Coronaviruses are RNA viruses
with glycoprotein spikes that give them a crown like
appearance [1,2]. Four species have been in circulation for
a long time and cause mild respiratory disease. They have a
lot of genetic diversity and have jumped the species barrier
leading to severe respiratory disease (the SARS virus in
2002-2003 and the MERS virus in 2012-2013). In December,
2019, a novel coronavirus emerged in Wuhan City of Hubei
Province in China; this was later termed as SARS-CoV-2 or
COVID-19. This virus has subsequently spread throughout the
world causing more than 3.7 million cases and 2,64,000
deaths (till May 07, 2020) [3]. More than 52,000 cases and
1700 deaths have been reported from India [4].
The disease spreads by droplets generated by
infected people during sneezing and coughing. These are
large droplets that travel for 1-2 m and settle on surfaces
on which the virus can remain alive for hours to days [5].
Infected persons can also spread the infection even before
the onset of symptoms. Infection is acquired by either
inhalation of infected droplets or touching surfaces/fomites
contaminated with the infected droplets and then touching
the eyes, nose or mouth. Incubation period varies from 2-14
days with a median of 5 days. The average number of people
infected by one infected individual is between two to three.
The clinical symptoms are variable, ranging from
asymptomatic state to acute respiratory distress syndrome
and multi-organ dysfunction. In adults, common symptoms
include fever, cough, breathlessness, fatigue, myalgia,
headache and sore throat, while vomiting, diarrhea, sneezing
and conjunctivitis are uncommon. Current evidence suggests
that 80-85% of cases are mild, 10-15 % are severe with lower
respiratory tract involvement, and 5% are critical, needing
ICU care. The fatality rate is reportedly between 2-3% but
can vary from 0.5-10% depending on the number tested, the
percentage of elderly people in the population and
availability of critical care support in the hospitals. The
severity and fatality are higher in the elderly, especially
above the age of 60 (among those aged more than 80 years,
fatality rate was 15%), and those with comorbidities like
heart disease, hypertension, diabetes etc. There is paucity
of data on COVID-19 in pregnancy and neonates. Available
data suggests that in general the outcome among pregnant
women and neonates is good. A large proportion of infected
pregnant women are likely to be asymptomatic or have mild
symptoms [6]. However, severe disease needing admission to
intensive care unit has been reported among pregnant women.
Emerging evidence indicates that among women infected with
COVID-19 in the third trimester, the risk of vertical
transmission is low. Reported clinical features of COVID-19
infection in neonates include fever, lethargy, cough,
vomiting and respiratory distress, thus mimicking the
presentation of bacterial sepsis [2,7,8].
METHODS
These guidelines have been developed jointly by the
Federation of Obstetric and Gynaecological Societies of
India, National Neonatology Forum of India, and Indian
Academy of Pediatrics. The GRADE approach recommended by
World Health Organization (WHO) was used to develop the
guideline [9]. A Guideline development group (GDG)
comprising of obstetricians, neonatologists and
pediatricians was constituted. The GDG drafted a list of
questions which are likely to be faced by clinicians
involved in obstetric and neonatal care.
An e-survey was carried out amongst a wider group of
clinicians to invite more questions and prioritize.
Literature search was carried out in PubMed combining the
search term (“coronavirus”[MeSH Terms] OR “coronavirus” [All
Fields])) AND 2019/12 [PDAT]: 2030 [PDAT]) OR 2019-nCoV [All
Fields] OR 2019nCoV [All Fields] OR COVID-19 [All Fields] OR
SARS-CoV-2 [All Fields]) with other key words relevant to
the practice question being answered (search updated on 30
April, 2020). In addition, websites of the relevant
international and national professional organizations were
searched [10-20]. Guidelines, systematic reviews, trials,
narrative reviews and other descriptive reports were
reviewed. For PICO (participants, intervention, control and
outcome) questions, the evidence was extracted into evidence
profiles. The context, resources required, values and
preferences were considered for developing the
recommendations.
OBECTIVES
The objective of these guidelines is to provide guidance on
the short-listed clinical practice questions (Box
I).
Box I Short-listed clinical
Practice Questions Addressed in the Guidelines |
Pregnant women with
travel history, clinical suspicion or confirmed
infection
1. What should be the care of
pregnant women with history of travel or exposure to
a confirmed/suspected case of COVID-19? 2. Which
pregnant women need testing for COVID-19? 3.
Where in a healthcare facility should a pregnant
woman with suspected or active COVID-19 infection
deliver? 4. What infection control measures
should be undertaken in triage, labor and delivery
of pregnant women with active or suspected COVID-19
infection? 5. What should be the method of labor
induction and mode of delivery in pregnant women
with active or suspected COVID-19 infection? 6.
What should be the specific care of pregnant women
with active COVID-19 infection?
Neonatal
care
7. What precautions should the neonatal
resuscitation team take when attending the delivery
of a woman with suspected or confirmed COVID-19
infection? 8. What should be the feeding policy
for stable neonates born to COVID-19 mothers? 9.
Is it necessary to separate the mother and baby if
mother is suspected or confirmed to be COVID-19
positive? 10. Should symptomatic neonates needing
intensive or special care be nursed in common room
NICU/SNCU or isolation facility? 11. What are the
special precautions to be taken while providing
respiratory support to neonates exposed to COVID-19
infection? 12. In symptomatic neonates, what is
the role of specific treatment in case of perinatal
exposure and in case of confirmed infection with
COVID-19?
Prevention and infection control
13. What should be the specific disinfection
practices in NICU /SNCU? 14. When should Personal
protective equipment (donning and doffing) be used?
15. What should be the biomedical waste disposal
protocol while managing a suspected or confirmed
case of COVID-19?
Diagnosis
16. What
should be the testing protocol for neonates born to
mothers with suspected or confirmed COVID-19?
General questions
17. What should be the
visitation policy and preventive measures for
visitors during the COVID-19 outbreak? 18. What
should be the discharge policy of neonates born to
suspected or confirmed COVID-19 mothers? 19. What
should be the occupational health policy specific to
COVID-19 pandemic? 20. What should be the
immunization policy for neonates born to suspected
or COVID-19 positive women? |
Pregnant Women
Of the 3323 articles on the coronavirus infection, 80
addressed the issue in pregnant women. No clinical trials
have compared specific care including isolation strategies
in pregnant women. A total of 13 studies (12 case
series/reports and 1 retrospective cohort study) reported
outcome in 113 women with pregnancy and coronavirus
infection [21-26]. Due to absence of comparative group it is
not possible to estimate the effect of COVID-19 infection in
pregnancy. However, almost all pregnant women had mild
infection. One died due to severe disease. No clinical
trials have compared specific care including isolation
strategies in pregnant women. Majority of women in these
studies were delivered by C-section; however, in the only
case-control study, all controls were also delivered by
C-section. Incidence of C-section is high in China, from
where all studies have originated, and it is not possible to
infer that Covid-19 infection increases the probability of
C-section.
Literature indicates possibility of higher incidence of
fetal distress in infected pregnant women. However, due to
small sample size and lack of comparison group, no definite
inference can be made. As severe disease and pneumonia have
been reported in few reports, pregnant women with infection
need to be monitored for respiratory compromise during
childbirth.
The treatment of COVID-19 viral infection has been
attempted by two approaches. The first approach is the use
of a combination of hydroxychloroquine and azithromycin
[27]. These drugs are readily available in India and are
cost-effective. The other approach has been to use antiviral
drugs, some of which are difficult to procure.
Hydroxychloroquine in a dose of 600 mg (200 mg thrice a day
with meals) and azithromycin (500 mg once a day) for 10 days
has been shown to give virologic cure on day 6 of treatment
in 100% of treated patients in one study. The study included
20 treated patients with upper and lower respiratory
symptoms. In this study, pregnancy was an exclusion
criterion. However, as such, both these drugs have been used
in pregnancy and during breastfeeding without significant
effects on the mother or fetus. Alternative dosage regimens
for hydroxy-chloroquine are to give 400 mg twice a day on
day 1 and then 400 mg once a day for the next four days.
Chloroquine can also be used as an alternative. The dose is
500 mg twice a day for 7 days. Some authorities recommend
that azithromycin should be added only where there is a
clinical suspicion of superadded bacterial infection.
Lopinavir-ritonavir was the first antiviral combination used
to treat COVID-19 infection. However, there was no
difference in time to clinical improvement or mortality at
28 days in a randomized trial of 199 patients with severe
COVID-19 given lopinavir-ritonavir (400/100 mg) twice daily
for 14 days in addition to standard care versus those
who received standard care alone [28]. Other agents such as
remdesivir are being evaluated in randomized trials [29].
Clinicians should follow the latest updated national
guidelines released by Indian Council of Medical
Research/Ministry of Health and Family Welfare.
Maternal-fetal Transmission and Neonatal Cases
Among 707 neonates reported born to Covid-19 positive women,
111 (15.7%) were admitted to NICU, 20 had pneumonia and 3
died. However, in majority of neonates, the reason of
admission to NICU was isolation from the infected mother or
other morbidities unrelated to COVID-19 infection. Among the
707 births, vertical transmission is suspected in 17
neonates (pooled rate of 2.4%), based on virologic and
serological reports [30-37]. However, two individual case
series have reported higher transmission rates of 7.1% (3 of
42) and 9.1% (3 of 33)
[36].
Of the 17 neonates with suspected vertical
transmission, infection was confirmed by a positive RT-PCR
in 11 (Web Table
I). In 3 neonates, infection was suspected based
on elevated anti-COVID-19 IgM and IgG levels at birth
[33,34]. In another 3 neonates, only IgG levels were
elevated [33]. In these 6 neonates with elevated antibodies,
RT-PCR was repeatedly negative indicating possibility of
intrauterine infection of the fetus. Pneumonia was the most
common manifestation of infection with 9 neonates of 11 with
positive RT-PCR showing clinical and/or radiological
evidence of pneumonia. Other clinical features included
fever, lethargy and gastrointestinal symptoms. However, the
disease was mild in most neonates with only one neonate
needing short duration respiratory support and all being
discharged alive from the hospital.
Isolation from mother was practiced in all but two
of these 17 neonates [35]. Maternal infection was confirmed
only in the postnatal period in mothers of these two
neonates. Breastfeeding was given by these mothers without
wearing masks. In one neonate RT-PCR was positive on day 1
and in second neonate it was positive on day 3.
Neonatal exposure definitions: As per the Chinese consensus guidelines, neonates
are said to be exposed to COVID-19 if they are born to
mothers with a history of COVID-19 infection
diagnosed within 14 days before delivery or 28 days after
delivery, or if the neonate is directly exposed to close
contacts with COVID-19 infection (including family members,
caregivers, medical staff, and visitors) [38]. They should
be managed as patients under investigation (PUI)
irrespective of whether they are symptomatic or not.
RECOMMENDATIONS
Pregnant Women With Travel History, Clinical
Suspicion or Confirmed Infection
Recommendation 1
•
Pregnant women with a history of travel or exposure
to a confirmed/suspected case of COVID-19 should be isolated
by using the ICMR guidelines for non-pregnant adults.
•
In the absence of community spread, isolation at the
designated facility and in the presence of community spread,
isolation by home quarantine may be preferred. For home
quarantine, the guidelines issued by ICMR/MoHFW should be
adhered to.
Recommendation 2
•
Testing for pregnant women should be done as per ICMR
testing strategy [39].
•
In addition, ICMR recommends pregnant women residing
in clusters/containment area or in large migration
gatherings/evacuation centres from hotspot districts
presenting in labor or likely to deliver in next five days
should be tested even if asymptomatic [40].
Asymptomatic pregnant women should be tested in the health
facilities where they were expected to deliver, and all
arrangements should be made to collect and transfer samples
to testing facilities. Women should not be referred for lack
of testing facility.
Recommendation 3
•
COVID care facilities should be identified in the
public and private sector. These would be large
multispecialty hospitals with adequate space, infrastructure
and logistics. Referral pathways from non-COVID facilities
should be well established.
•
In such COVID care facilities, three demarcated
zones, each housing all the needed equipment and services
(wards, labor rooms, operation theatres, neonatal
resuscitation areas and mother and neonatal ICU) are
required for management of healthy, suspected and confirmed
COVID-19 mothers.
The standards and facilities required for infection
control in these areas should be same as that for other
adults with suspected or confirmed COVID-19.
•
Every pregnant woman should be triaged at entry and
then allotted into one of the zones depending on the
presentation.
•
If a woman who delivers in a non-COVID facility turns
out to be Covid-19 positive, actions should be taken as per
MOHFW’s ‘Guidelines to be followed on detection of
suspect/confirmed COVID-19 case in a non-COVID health
facility’[41].
Recommendation 4
•
When providing healthcare to women in labor with
confirmed or suspected COVID-19 infection, follow standard
universal precautions to prevent contact with body fluids.
In addition, use personal protective equipment (PPE) to
prevent acquiring infection through respiratory droplets.
The PPE should include masks such as the N95
and face protection by a face shield or at least
goggles.
•
Reception and triage should be in the same room that
is to be used for admission in labor and delivery. Ideally,
this should be a room with negative pressure (If not
available, exhaust fans can be installed).
•
Keep the room free from any unnecessary items
(decorations, extra chairs, etc.) which could act as
infected fomites later.
•
There should be a restriction on the number of
attendants and non-essential staff into the room.
•
There should be facilities for health care providers
to remove and safely discard PPE at the exit of the room in
which the patient is being cared for.
Recommendation 5
•
Mode of delivery in pregnant women infected with
COVID-19 should be guided by their obstetric assessment and
physiological stability (cardiorespiratory status and
oxygenation). COVID-19 infection itself is not an indication
for induction of labor or operative delivery.
•
Continuous electronic fetal monitoring should be done
during labor. If facilities for continuous electronic fetal
monitoring are not available, manual monitoring by frequent
auscultation of fetal heart rate should be done during the
labor, as indicated for a high-risk delivery.
•
Adequate equipment and trained healthcare providers
should be available for intrapartum monitoring and obstetric
interventions as indicated in the separate childbirth
facilities for infected pregnant women.
•
Oxygenation status of women during labor should be
monitored by a pulse oximeter and oxygen therapy should be
titrated to maintain oxygen saturation of more than 94%.
Recommendation 6
•
Pregnant women with active COVID-19 infection should
be managed with supportive care recommended for non-pregnant
adults. Current guidelines by the Government of India do not
recommend use of hydroxychloroquine, chloroquine or
antiviral drugs in pregnant women.
•
Currently recommended national management includes: -
oxygen therapy/respiratory support for treatment of
hypoxemic respiratory failure, fluid therapy, antibiotics
and management of shock.
The choice of specific antiviral therapy is likely
to change with rapidly emerging evidence and updated
national guidance should be consulted. Updated guidance can
be accessed at the website of Ministry of Health and Family
Welfare: https://www.mohfw.gov.in/
Neonatal Care
Recommendation 7
Recommendations for neonatal resuscitation:
•
If possible, resuscitation of neonate can be done in
a physically separate adjacent room earmarked for this
purpose. If not feasible, the resuscitation warmer should be
physically separated from the mother’s delivery area by a
distance of at least 2 meters. A curtain can be used between
the two areas to minimize opportunities for close contact.
•
Minimum number of personnel should attend (one person
in low risk cases and two in high risk cases where extensive
resuscitation may be anticipated) and wear a full set of
personal
protective equipment including N95 mask.
•
Mother should perform hand hygiene and wear triple
layer mask.
•
The umbilical cord should be clamped promptly and
skin to skin contact avoided.
•
Delivery team member should bring over the neonate to
the resuscitation area for assessment by the neonatal team.
•
Neonatal resuscitation should follow standard
guidelines. If positive-pressure ventilation is needed,
self-inflating bag and mask or a T-piece resuscitator with
disposable tubing may be used. Disposable parts should be
discarded (even if not used) and reusable equipment/parts
should be disinfected after each delivery.
•
Routine suction is not indicated for clear or
meconium stained amniotic fluid.
•
Endotracheal administration of medications should be
avoided.
•
Indications for intubation shall not change because
of maternal COVID-19 status. Plexiglass boxes with access
portholes can be used to minimize aerosol spread during
intubation and suction.
•
Disposables like endotracheal tubes, suction
catheter, orogastric tube, tapes for fixing ET tube,
umbilical catheter, syringes placed near the resuscitation
area should be discarded even if unused. Reusable equipment
should be thoroughly disinfected as per hospital protocol.
•
Bathing is not recommended in view of risk of
hypothermia and hospital acquired infections.
Recommendation 8
A. Stable
neonates exposed to COVID-19 infection from mothers or other
relatives should be roomed-in with their mothers and be
exclusively breastfed. For supporting lactation, nurses
trained in essential newborn care and lactation management
should be provided. A healthy willing family member who is
not positive for COVID-19, and has not been in direct
contact with suspected or confirmed COVID-19 person and is
asymptomatic may be allowed in the room to provide support
for breastfeeding and helping in taking care of the neonate.
B. If rooming-in is not possible because of the
sickness in the neonate or the mother, the neonate should be
fed expressed breast milk of the mother by a nurse or a
trained family member who has not been in contact with the
mother or other suspected/proven case, provided the neonate
can tolerate enteral feeding.
Weak recommendation, based on consensus among
experts in the absence of evidence for any beneficial effect
or harm in the risk of COVID-19 following direct
breastfeeding or expressed breastmilk feeding.
Conditions to be met for safe breastfeeding:
•
Mothers should perform hand hygiene frequently, including
before and after breastfeeding and touching the baby.
•
Mothers should practice respiratory hygiene and wear a mask
while breastfeeding and providing other care to the baby;
they should routinely clean and disinfect the surfaces.
•
Mothers can express milk after washing hands and breasts and
while wearing a mask. If possible, a dedicated breast pump
should be provided. If not, it should be decontaminated as
per protocol. This expressed milk can be fed to the baby
without pasteurization. The collection and transport of EBM
to the baby should be done very carefully to avoid
contamination.
C. Mothers are not eligible to donate milk in any
of the following COVID-19 related
situations in addition to standard criteria [42].
•
COVID-19 positive donor till she is declared free of
infection.
•
History of having stayed or transited in a containment zone
during the previous 14 days.
•
History of close contact with a confirmed or probable case
of COVID-19 in previous 14 days.
•
Suffering from symptoms like cough, fever, sore throat,
running nose till found to be COVID-19 negative on
nasopharyngeal sample RT-PCR.
• Person
who worked in or attended a health care facility in which a
case of COVID-19 infection has been confirmed.
Recommendation 9
•
Healthy neonate may be roomed-in with mother. The
mother-baby dyad must be isolated from other suspected and
infected cases and healthy uninfected mothers and neonates.
•
Direct breastfeeding can be given. Mother should wash
hands frequently including before breastfeeding and wear
mask. If needed due to neonatal or maternal condition,
expressed breast milk may also be fed.
•
If safe, early discharge to home followed by
telephonic follow-up or home visit by a designated
healthcare worker may be considered.
Recommendation 10
•
Neonates who are symptomatic/ sick and are born to a
mother with suspected or proven COVID-19 infection should be
managed in separate isolation facility.
•
This area should be separate from the usual NICU/SNCU
with a transitional area in-between. This isolation facility
should preferably have single closed rooms.
•
In case enough single rooms are not available, closed
incubators (preferred) or radiant warmers could be placed in
a common isolation ward for neonates. The neonatal beds
should be at a distance of at least 1 meter from one
another. Suspected COVID-19 cases and confirmed COVID-19
cases should ideally be managed in separate isolations. If
it is not feasible to have separate facilities and the
neonates with suspected and confirmed infection are in a
single isolation facility, they should be segregated by
leaving enough space between the two cohorts.
•
The isolation ward should have a separate double door
entry with changing room and nursing station. It should be
away from routine NICU/SNCU/labor room/postnatal ward in a
segregated area which is not frequented by other personnel.
The access to isolation ward should be through dedicated
lift or guarded stairs.
•
Negative air borne isolation rooms are preferred for
patients requiring aerosolization procedures (respiratory
support, suction, nebulization). If not available, negative
pressure can also be created by exhaust fans driving air out
of the room.
•
Isolation rooms should have adequate ventilation. If
room is air-conditioned, ensure 12 air changes/ hour and
filtering of exhaust air. These areas should not be a part
of the central air-conditioning.
•
The doctors, nursing and other support staff working
in these isolation rooms should be separate from the ones
who are working in regular NICU/SNCU. The staff should be
provided with adequate supplies of PPE. The staff also needs
to be trained for safe use and disposal of PPE.
If the facilities of isolation intensive care are
not available in the hospital where symptomatic or sick
newborn is born or referred with COVID-19 infections, the
newborn should be immediately shifted to the closest state
designated COVID hospital where such facilities are
available. Complete safety, PPE policies and precautions
must be followed during transport.
Recommendation 11
•
Respiratory support for neonates with
suspected/proven COVID-19 infection is guided by principles
of lung protective strategy including use of non-invasive
ventilation.
•
NIPPV and high flow nasal cannulas should preferably
be avoided.
•
Healthcare providers should practice contact and
droplet isolation and wear N95 mask while providing care in
the area where neonates with suspected/proven COVID-19
infection are being provided respiratory support.
•
If intubation is needed:
•
Consider use of pre-medication for non-emergent intubation.
•
Intubation should be performed by the healthcare worker who
is most experienced with airway management.
•
Consider use of aerosol box during intubation and suction.
•
Consider using in-line suction device.
• Attach
a HEPA filter in the path of exhaled gas when using a
mechanical ventilator or positive pressure ventilation
device.
• The
area providing respiratory support should be a negative air
pressure area.
Recommendation 12
•
Specific anti-COVID-19 treatment - antivirals or
chloroquine/hydroxychloroquine - is NOT recommended in
symptomatic neonates with confirmed or suspected COVID-19.
Weak recommendation, based on consensus among
experts in the absence of evidence for any beneficial effect
or harm with the use of any of the options available.
•
Use of adjunctive therapy such as systemic
corticosteroids, intravenous gamma globulin and convalescent
plasma is NOT recommended in symptomatic neonates with
confirmed or suspected COVID-19.
Weak recommendation, based on consensus among
experts in the absence of evidence for any beneficial effect
or harm with the use of any of the options available.
Prevention and Infection Control
Recommendation 13
Disinfection of surfaces in the childbirth/neonatal care
areas for patients with suspected or confirmed Coronavirus
infection are not different from those for usual Labor
room/OT/NICU/SNCU areas and include the following [12]:
•
Wear personal protective equipment before
disinfecting
•
If equipment or surface is visibly soiled first clean
with soap and water solution or soaked cloth as appropriate
before applying the disinfectant
•
0.5% sodium hypochlorite (equivalent to 5000 ppm) can
be used to disinfect large surfaces like floors and walls at
least once per shift and for cleaning after a patient is
transferred out of the area.
•
70% ethyl alcohol can be used to disinfect small
areas between uses, such as reusable dedicated equipment.
•
Hydrogen peroxide (dilute 100 ml of H2O2 10%
v/v solution with 900 ml of distilled water) can be used for
surface cleaning of incubators, open care systems, infusion
pumps, weighing scales, standby equipment-ventilators,
monitors, phototherapy units, and shelves. Use H2O2 only
when equipment is not being used for the patient. For
ensuring the efficacy of disinfection with H2O2 use
the contact period recommended by manufacturer. Usually a
contact period of 1 hour is required.
Recommendation 14
Minimal composition of a set of PPE for the management of
suspected or confirmed cases of COVID-19 infection is
provided in Box II.
Box II Desired Protection
and Suggested Personal Protection Equipment for the
management of Suspected/Confirmed patient of
COVID-19 |
Respiratory
protection • Triple layered surgical mask
• N95 facemasks are needed when performing an
aerosol-generating procedure or in an area where
neonates are being provided respiratory support by
CPAP device/ventilator. Eye protection
Goggles (will not be usable by those using vision
glasses) or face shield Body protection
Full-sleeved water-resistant gown including head
and complete shoe cover. A single piece head to toe
water resistant body cover will be ideal for
attending resuscitation in delivery room or OT
Hand protection Well-fitting gloves
|
Recommendation 15
•
Follow routine biomedical waste disposal handling,
segregation, transport and final disposal guidelines as
prescribed by the Government of India [15].
Diagnosis
Recommendation 16
Guidelines on testing of neonates for COVID-19 are provided
in Box III.
Box III Guidelines for Testing of Neonates
for COVID-19 |
Which neonates?
• History of exposure to COVID-19 positive
adult (Irrespective of symptoms): o Mother had
COVID-19 infection within 14 days before birth, or
o History of contact with COVID-19 positive persons
(including mother, family members in same household
or direct healthcare provider) in postnatal period
• Irrespective of history of exposure: o
Presenting with pneumonia or SARI that requires
hospitalization, with onset at more than 48-72 h of
age, unless there is another underlying illness that
completely explains the respiratory signs and
symptoms. Features which suggest acute
respiratory illness in a neonate are respiratory
distress, with or without cough, with or without
fever.
When? • If symptomatic,
specimens should be collected as soon as possible
• If asymptomatic, take swab at 48 hours. If
neonate’s test at 48 hours is negative, repeat test
should be done between 5-14 days.
What
sample? Not mechanically ventilated: Upper
respiratory nasopharyngeal swab (NP). Collection of
oropharyngeal swabs (OP) is a lower priority and if
collected should be combined in the same tube as the
NP swab. Mechanically ventilated: Tracheal
aspirate sample should be collected and tested as a
lower respiratory tract specimen in addition to NP
swab.
How to collect? Upper
nasopharyngeal swab • Use only synthetic fiber
swabs with plastic shafts. Do not use calcium
alginate swabs or swabs with wooden shafts, as they
may contain substances that inactivate some viruses
and inhibit PCR testing. • Insert a swab into
nostril parallel to the palate. Swab should reach
depth equal to distance from nostrils to outer
opening of the ear. Leave swab in place for several
seconds to absorb secretions. Slowly remove swab
while rotating it. • Place swabs immediately into
sterile tubes containing 2-3 mL of viral transport
media. Oropharyngeal swab (e.g., throat swab)Swab
the posterior pharynx, avoiding the
tongue.Nasopharyngeal wash/aspirate or nasal
aspirateCollect 2-3 mL into a sterile, leak-proof,
screw-cap sputum collection cup or sterile dry
container.Other samples Currently not advised;
stool, urine and blood specimens, since the
isolation is less reliable than from respiratory
specimens. Do not take these specimens for testing
(based on current advisory recommendations)
What PPE is needed for sample collection?
Clinicians should wear appropriate personal
protective equipment during sampling.
Nasopharyngeal swab • Hand hygiene •
Disposable single use glove • Disposable plastic
apron • Surgical facemask • Eye protection
(surgical mask with integrated visor or full-face
shield or visor or goggles/safety spectacles) For
any sampling from lower respiratory tract in
intubated neonates, a full set of PPE is a must.
• Hand hygiene • disposable single use glove
• Long sleeved disposable gown • N95 mask or
another respirator mask • Eye protection
Labelling the sample Label each specimen
container with the patient’s name, hospital ID
number, specimen type and the date the sample was
collected. Handle the sample with precautions under
biosafety level 3 (BSL-3) conditions until is
rendered non-infectious by laboratory.
How to store? Samples should be collected in
viral transport media procured from microbiology
laboratory and transported immediately in icepacks.
One can use disposable thermocol cartons or plastic
bags with ice cubes for in-house transport. If
sending to another laboratory, store specimens at
2-8°C for up to 72 h after collection. Storage can
be done in a refrigerator dedicated for this
purpose. If a delay in testing or shipping is
expected, store specimens at -70°C or below. This
requires deep freezers.
How to send?
If transporting by shipping, the samples need to be
packed as per instructions Guidance for sample
Collection, Packaging and Transportation for Novel
Coronavirus.
Where to send?
Authorized laboratories (See MOHFW website for
latest list )
What test? Reverse
transcriptase PCR is a rapid test for detecting
COVID-19
|
General Questions
Recommendation 17
•
Parents and families of the COVID-19 exposed,
suspected and infected mothers and neonates should receive
informed healthcare. They should be aware of and understand
the isolation, monitoring, diagnostic and treatment plans of
the mothers/babies and be given a periodic update about the
health condition.
•
Visitors to both routine and COVID-19 specific
childbirth/neonatal care areas should be screened for
symptoms of COVID-19 infection.
•
Persons (including parents) with suspected or
confirmed COVID-19 infection should not be allowed entry in
the childbirth/neonatal care area where care to parturient
women/sick neonates is being provided.
•
For neonates roomed in with mother having
suspect/confirmed COVID-19 infection, one healthy family
member following contact and droplet precautions should be
allowed to stay with her to assist in baby care activities.
•
Visitation policy for COVID-19 infected mother to see
her neonate admitted in NICU. Mother may be allowed to visit
if
•
Resolution of fever without the use of antipyretics for at
least 72 hours AND
•
Improvement (but not full resolution) in respiratory
symptoms AND
•
Negative results of a molecular assay for detection of
SARS-CoV-2 from at least two consecutive nasopharyngeal swab
specimens collected
³24 hours apart
Recommendation 18
•
Stable neonates exposed to COVID-19 and being
roomed-in with their mothers may be discharged at time of
mothers’ discharge.
Weak recommendation, based on consensus among
experts based on the incubation period of SARS-CoV-2
infection in adults and older children.
•
Stable neonates in whom rooming-in is not possible
because of the sickness in the mother and are being cared by
a nurse or a trained family member may be discharged from
the facility by 24-48 hours of age.
Weak recommendation, based on consensus among
experts in the absence of evidence for any beneficial effect
or harm with early discharge following exposure to COVID-19
Remarks
•
Early discharge to home may be followed by a
telephonic follow-up or home visit by a designated
healthcare worker.
•
Mothers and family members should be counselled
regarding the danger signs and advised to report back to the
facility if the neonate develops any of the danger signs
•
If the neonate develops any danger signs or becomes
unwell during home isolation, he/she should be taken to a
designated hospital facility for assessment as well as
COVID-19 testing (if indicated)
•
Mothers and family members should perform hand
hygiene frequently including before and after touching and
feeding the baby
•
Mothers should practice respiratory hygiene and wear
a mask while breastfeeding and providing other care to the
baby; they should routinely clean and disinfect all the
surfaces.
•
If the discharged neonate is positive for COVID-19,
uninfected individuals >60 years of age (e.g.
grandparents) and those with comorbid conditions should not
be assigned to provide care if possible.
Recommendation 19
•
Healthcare professionals working in any childbirth or
neonatal area should report to their supervisor if they have
respiratory or other symptoms suggestive of COVID-19
infection. Such healthcare professional should not be put on
clinical duty and should be replaced by a healthy healthcare
professional to maintain appropriate patient-provider ratio.
•
Healthcare professionals directly involved in the
care of patients with suspect/proven COVID-19 infection may
consider taking hydroxychloroquine (HCQ) prophylaxis as
advised by Government of India, on medical prescription
[43]. However, this advisory is based on low-quality
evidence and may change in near future.
Recommendation 20
•
Follow routine immunization policy in healthy
neonates born to mothers with suspected/proven COVID-19
infection [44].
•
In neonates with suspected/proven infection,
vaccination should be completed before discharge from the
hospital as per existing policy.
Conclusion
This clinical practice guideline has been jointly developed
by FOGSI-IAP-NNF based on the current scientific literature,
advisories issued by ICMR and MoHFW and the ground realities
of Indian healthcare system. However, our understanding of
SARS-Covid-2 virus is incomplete and new insights are being
gained everyday. In due course, the guideline shall need to
be revised. Readers should check for latest updates.
Disclaimer:
The guidelines in this document are based on limited
evidence, as is available now. As new evidence accumulates,
some of the recommendations may change. Users should use
these guidelines in accordance with the latest government
regulations and ICMR advisories.
Funding:
None. Competing interests: None stated.
Annexure I
Use of Personal Protective Equipment
Sequence of Donning
Before wearing the PPE for managing a suspected or confirmed
COVID-19 case, proper hand hygiene should be performed. The
gown should be donned first. The mask or respirator should
be put on next and properly adjusted to fit; remember to fit
check the respirator. The goggles or face shield should be
donned next and the gloves are donned last. Keep in mind,
the combination of PPE used, and therefore the sequence for
donning, will be determined by the precautions that need to
be taken.
Steps in Removing PPE (Doffing)
Wearing the PPE correctly will protect the healthcare worker
from contamination. After the patient has been examined or
desired procedure is performed, the removal of the PPE is a
critical and important step that needs to be carefully
carried out in order to avoid self-contamination because the
PPE could by now be contaminated.
1. The gloves are
removed first because they are considered a heavily
contaminated item. Use of alcohol-based hand disinfectant
should be considered before removing the gloves. Dispose of
the gloves in a biohazard bin.
2. After the
removal of gloves, hand hygiene should be performed, and a
new pair of gloves should be worn to further continue the
doffing procedure. Using a new pair of gloves will prevent
self-contamination. Unbuttoning of the backside of the gown,
performed by an assistant. Removal of gown to be performed
by grabbing the back side of the gown and pulling it away
from the body. Single-use gowns can now be disposed of;
reusable gowns have to be placed in a bag or container for
disinfection
3. After the
gown, the goggles should be removed and either disposed if
they are single-use, or placed in a bag or container for
disinfection. In order to remove the goggles, a finger
should be placed under the textile elastic strap in the back
of the head and the goggles taken off. Touching the front
part of the goggles, which can be contaminated, should be
avoided. If goggles with temples are used, they should be
removed as per manufacturer's recommendations.
4. The
respirator/ mask should be removed next. In order to remove
the respirator/mask, a finger or thumb should be placed
under the straps in the back and the respirator taken off.
The respirator (or the surgical mask) should be disposed of
after removal. It is important to avoid touching the
respirator/mask with the gloves (except for the straps)
during its removal.
5. The last PPE items
that should be removed are the new set of gloves that were
worn after disposal of the contaminated gloves. Use of
alcohol-based solution should be considered before removing
the gloves. The gloves should be removed Dispose of the
gloves in a biohazard bin.
6.
After glove removal, hand hygiene should be performed.
Annexure II
Guideline Development Group (Alphabetical)
Chairperson:
Praveen Kumar,
Professor, Department of Pediatrics, PGIMER,
Chandigarh.
Deepak Chawla, Department of Neonatology,
GMCH Chandigarh; Dinesh Chirla, Intensive Care
Services, Rainbow Children's hospital group; Samir
Dalwai (National Joint Secretary IAP), Pediatrician,
Nanavati and Hinduja Hospitals, Mumbai; Ashok K Deorari
(President NNF), Department of Pediatrics, AIIMS, New
Delhi; Atul Ganatra (Vice-President FOGSI), Dr. R J
Ganatra's Nursing Home, Mumbai; Alpesh Gandhi
(President FOGSI), Department of Obstetrics & Gynecology,
Arihant Women's hospital, Ahmedabad;
Nandkishor S Kabra, Surya
Hospital, Mumbai; Pratima Mittal, Deppartment
of Obstetrics & Gynecology, VMMC and SJH, New Delhi;
Bakul Jayant Parekh (National President IAP), BPCH and
tertiary care Center, Mumbai; M Jeeva Sankar,
Deppartment of Pediatrics, AIIMS, New Delhi; Tanu
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