Topical oil massage is routinely practiced
in many countries. For hundreds of years, populations especially in
the Indian subcontinent have routinely applied natural oils to the
skin of newborn. The practice of oil massage has gained favor in
neonatal intensive care units in the developed countries as well(1).
The putative benefits to the newborn are twofold,
those related to the oil application per se, and those related to
tactile kinesthetic stimulation due to the massage. Topical oil
application has been shown to improve skin barrier function,
thermoregulation and also is suggested to have a positive effect on
growth(2,3). A role for absorption of fats through the thin skin of
the preterm has also been suggested. Moreover, a number of studies
have also demonstrated superior growth and development in preterm
infants receiving tactile kinesthetic stimulation(4-8). Oil
application may occasionally cause adverse effects in the form of skin
rashes and a greater propensity for bacterial colonization(1).
This study was, therefore, undertaken to compare
the effect of massage with coconut oil versus mineral oil and placebo
(powder) on growth velocity and neuro-behaviour as well as adverse
effects if any on well preterm and term babies.
Subjects and Method
This open randomized controlled trial was conducted
in the premature unit and the postnatal wards of a major tertiary care
center in a metropolitan city between 1st August 2003 to 31st January
2004. The study was approved by the hospital ethics committee.
Inclusion criteria
Intramural preterm appropriate for gestational age
babies weighing between 1500-2000 grams and full term neonates
weighing 2500 grams or more were included if they fulfilled the
following inclusion criteria:
1. Apgar score >7 at 1 and 5 minutes with no
resuscitation required at birth.
2. Medically stable with no requirement of
drugs (other than mineral and vitamin supplements for the preterm
babies), or any interventions/procedures.
3. On breastfeeds or ‘spoon-wati’ feeds with
expressed breastmilk (preterms).
4. Adequate family support.
Exclusion criteria
Sick babies, those with congenital anomalies or
neuromuscular disorders were excluded. Babies of parents who were
staying far away from the hospital and were therefore less likely to
follow-up were excluded, as were babies of parents who refused consent
for the study.
Outcome variables
The primary outcome measure was the weight gain
velocity over the first thirty-one days of life. Secondary outcome
measures included length gain velocity , head growth, neuro-behavioral
outcome and incidence of adverse events.
Sample size
A sample size of 36 infants would be required in
each group of preterm and term infants in order to detect a difference
in weight gain velocity of 2 g/kg/day with a SD of 2.7 g/kg/day (based
on observations from a pilot study), a power of 80% and error of 0.05
and allowing for a 20% loss to follow-up.
Randomization
Infants in preterm and term group were randomized
in blocks of three by computer-generated numbers in closed opaque
envelopes, to either coconut oil, mineral oil , or placebo (powder)
groups
Details of the antepartum period including the
obstetric history, mode of delivery, adequacy of family support, the
socio-economic status, presence of risk factors for sepsis and the
need for resuscitation at birth were recorded.
Massage technique
Oil massage was given by a trained person from day
2 of life till discharge, and thereafter by the mother (who was taught
the technique) until 31 days of age. Babies in the placebo group
received a massage using baby powder and the method of application and
the monitoring was the same as in the oil groups. Sessions began an
hour after a feed. The total duration of each session was 5 minutes
and was done four times a day.
The oil massage was given in the prone and supine
positions to include head, neck, trunk and the extremities. At the end
of the massage kinesthetic stimulation was provided in the supine
position by passive flexion and extension movements of the limbs at
each large joint (shoulder, elbow, hip, knee and ankle) as 5 events of
2 seconds. The procedure for the massage and stimulation were as per
the procedure described by Mathai et al.(4). If the baby
started crying or passed urine or stools during the session it was
temporarily stopped till the baby was comfortable again.
During the massage, preterm infants were nursed
naked and under a radiant warmer with skin mode of temperature
control. Oxygen saturation was continuously monitored through out the
duration of the procedure using pulse oximeter (Novametrix 515 C).
Readings were recorded of heart rate, respiratory rate, temperature
and oxygen saturation in the three subgroups before, during and
immediately after the massage. Term infants were massaged in a draught
free room. Similar parameters were recorded.
In accordance with unit protocols all term and
preterm neonates above 1700 grams were breast fed from day1. Babies
between 1500 - 1700 gram birth weight were put on enteral feeds of
expressed /banked human milk starting at 80 mL/kg /day on day one. The
milk was fed by wati and spoon or gavage till babies were able
to accept full volume per feed by wati-spoon /breastfeeds. All
preterm infants were given oral calcium, phosphorus and vitamin
supplements. Mothers were allowed to touch and hold their infants as
often as they wished in all the subgroups. On discharge all mothers
were advised to carry out the massage in a draught-free room and limit
the procedure to 5 minutes per session.
Weight of infants was taken without clothes on an
electronic weighing scale (Phillips) with an accuracy of ± 5 grams.
Head circumference was measured with a non-stretchable cloth-tape and
length with an infantometer.
Babies were followed up daily during their stay in
the hospital and then once every week till 31 completed days of life.
Neonatal behavioral assessment
The Brazelton Neonatal Behavioral Assessment Scale
(BNBAS)(9,10) was administered to each infant in the study on three
occasions before the first massage, on day 7-10 and on follow-up (at
28-31 days). All the tests were done by a single trained person.
Infants were tested mid-way between two feeds in a quiet room. The
parameters assessed included ‘habituation’, ‘orientation’, ‘motor’
maturity, ‘range of state’, ‘regulation of state’, autonomic
stability’, ‘reflexes’ and ‘inter-active behavior’.
Statistical Analysis
Data collected was entered in Microsoft Excel 97
worksheet. Characteristics of infants included in the study were
tabulated as averages (means) with standard deviation (SD). The groups
were compared on each parameter using ‘t’ test (2-tailed unpaired) for
parametric data and chi square test for non-parametric data. The
analysis was done using the SPSS version 11 for windows. A ‘P’
value of <0.05 was considered as statistically significant and < 0.001
as highly significant.
Results
A total of 224 babies (112 preterm and 112 term
babies) were enrolled. In each gestation strata, there were 38 babies
in the coconut oil, 37 in the mineral oil and 37 babies in the placebo
groups. In the preterm group, 32 (84.2%) babies completed the follow
up in the coconut oil and mineral oil subgroups and 31 (83.8%) in the
placebo group. In the term babies, 33 (86.8%) completed the follow up
in the coconut oil group and 32 babies (86.5%) completed the follow up
in the mineral oil and placebo groups. The difference was not
statistically significant.
Table I shows the baseline characteristics of
babies enrolled in the study groups. There was no statistically
significant difference between babies enrolled in each of the groups
as far as the birthweight, gestational age, total length and head
circumferences were concerned.
Table III shows the growth characteristics of
term babies in the three groups. There was no statistically
significant difference in the weight at 14 and 31 days. Weight gain
velocity over the first 31 days was higher in the coconut oil group as
compared to the placebo group (P = 0.02). However, the weight
gain velocity was not significantly different between the coconut oil
and mineral oil groups. There was no statistically significant
difference in the length and head circumference at 14 and 31 days in
the three groups. No significant difference was noted in the length
and head circumference gain velocities.
TABLE III
Growth Characteristics in Term Group
Variable |
Coconut oil |
Mineral oil |
Placebo |
Weight (g) |
|
|
|
at 14 days |
3007.58 ± 366.60 |
2913.04
± 246.90 |
2940.63
± 332.27 |
at 31 days |
3538.46 ± 413.82 |
3473.00
± 289.60 |
3518.52
± 336.60 |
Weight gain
velocity (g/kg/day) |
9.19
± 1.55 £ |
8.78
± 1.67 |
8.22
± 1.76 |
Length (cm) |
|
|
|
at 14 days |
49.49 ± 2.37 |
49.49
± 1.86 |
49.92
± 2.20 |
at 31 days |
51.13 ± 2.64 |
51.26
± 1.97 |
51.83
± 2.13 |
Length gain
velocity (cm/week) |
0.64
± 0.18 |
0.66
± 0.19 |
0.71
± 0.21 |
Head circumference
(cm) |
|
|
|
at 14 days |
33.33 ± 1.09 |
33.15
± 0.82 |
32.89
± 1.02 |
at 31 days |
34.42 ± 0.96 |
34.31
± 0.92 |
34.46
± 1.13 |
Head circumference
gain velocity (cm/week) |
0.48
± 0.05 |
0.49
± 0.06 |
0.47
± 0.09 |
Chest circumference
(cm) |
|
|
|
at 14
days |
31.15 ± 0.94 |
30.64
± 0.92 |
30.67
± 1.09 |
at 31 days |
31.77 ± 0.93 |
31.54
± 0.94 |
31.82
± 1.09 |
Values are as mean ± standard deviation.
£: p<0.05 coconut oil vs placebo
Neuro-behavioral outcome as assessed by the
Brazelton scale was similar in the three groups for both preterm and
term babies.
Adverse events
In the preterm group, adverse events occurred in 6
babies, 2 each in the coconut oil, mineral oil and the placebo group.
All the adverse events were mild rash and did not require
discontinuation of application. Among the term babies, 3 in the
coconut oil group, 3 in the mineral oil group and 2 in the placebo
group developed mild rash that did not require discontinuation of
application.
Discussion
We studied the growth and neuro-behavioral benefits
of coconut versus mineral oil massage oil in term and preterm babies.
Several studies have already documented the somatic and
neurodevelopmental benefits of tactile kinesthetic stimulation in
preterm infants(4,11). To determine whether the benefits were due to
the effect of the massage or due to the type of oil used, these two
groups were compared with the placebo group who received massage with
powder.
The weight of preterm babies in the three groups
was comparable at baseline. However, at 14 days there was significant
weight gain in the coconut oil subgroup as compared to the placebo
subgroup whereas at 31 days, the weight was significantly higher in
the coconut oil subgroup as compared to placebo as well as the mineral
oil group. As weight gain in preterm neonates is also a function of
their birth weight, we calculated the weight gain velocity over the
31-day period. We found that the weight gain velocity was
significantly higher in the coconut oil subgroup as compared to the
other subgroups and the difference was statistically significant. The
length gain velocity was also significantly higher in the coconut oil
subgroup as compared to the placebo subgroup.
Other studies have found better somatic growth
after oil application. Application of a barrier such as oil or
emollient prevents insensible water loss from the skin and helps to
maintain temperature(12-14). Better thermo-regulation may promote
better weight gain.
Though most studies have looked at weight gain in
preterm neonates, we also wanted to study the growth in term neonates
after oil application so that the benefits, if any, could be extended
to this group. There was no significant difference in the weight at 14
and 31 days between the three groups. On analysis of the weight gain
velocity, there was a statistically significant difference between the
coconut oil and placebo groups. Though babies in the coconut oil group
had a better weight gain velocity as compared to the mineral oil
group, the difference was not statistically significant.
The findings of this study suggest that coconut oil
application improves the weight gain velocity in preterm and fullterm
neonates over and above the benefits of tactile kinesthetic
stimulation due to massage alone (placebo group). Preterm neonates
also showed a higher weight gain velocity after application of coconut
oil as compared to mineral oil application. This suggests a role for
transcutaneous absorption of vegetable oil through the thin skin of
the preterm neonate. The skin of a preterm baby allows significant
absorption of fat, as it is thinner and more vascular(15,16).This may
also result in greater caloric intake and hence a better weight
gain(17).
Fernandez, et al.(17) reported a
significantly higher serum triglyceride levels in preterm neonates
weighing 1500-2250 g after application of corn oil every four hours
for three days suggesting the likelihood of fatty acid absorption
through the skin of preterm neonates. Soriano, et al(18)
reported a significant increase in anthropometric parameters at one
month of age in 30 consecutive preterm infants who were treated
cutaneously with soybean oil compared to a control group, which
received no cutaneous treatment. An increase in linoleic acid level in
their blood was also observed
In preterm neonates, the length gain velocity was
significantly higher in the coconut oil subgroup as compared to the
placebo group. No significant difference was observed in the head
circumference in the three groups at 14 and 31 days. There was no
significant difference in the rate of head growth. In term neonates,
there was no statistically significant difference in the length gain,
head circumference, or in the in the rate of head growth, between the
three subgroups at 14 and 31 days. In contrast, Agarwal, et al.(6)
observed that full term infants at 6 weeks massaged with sesame oil
showed a significant increase in length, midarm and midleg
circumferences compared to infants receiving herbal oil, mustard oil,
or mineral oil for massage daily for 4 weeks.
In the preterm group as well as in the term group,
neurobehavioral outcome as assessed by the Brazelton Neonatal
Behavioral Assessment Scale (BNBAS) did not show any statistical
significance in the groups receiving oil massage compared to placebo.
Mathai, et al.(4) have shown better neurobehavioral outcome
after tactile kinesthetic stimulation with oil. However they compared
the benefits after tactile kinesthetic stimulation with oil or powder
with a control group who did not receive stimulation at all.
Therefore, the benefits observed in their study were probably because
of the tactile kinesthetic stimulation rather than the oil used.
Acknowledgements
The authors acknowledge and thank the Dean,
Lokmanya Tilak Municipal General Hospital, Dr. M.E. Yeolekar, for
granting them permission to undertake this study at LTMGH. The authors
also acknowledge with thanks the guidance and technical help provided
by R.B. Mohile, Head Research & Development, Marico Industries Ltd. We
also thank Ms. Sunanda Suryavanshi for training the mothers in the
technique of massage.
Contributors: SK participated in designing the
study, supervising the randomization and data collection and drafted
this paper. JM designed and coordinated the study and drafted the
paper. MMC helped in designing the study and supervised data
collection and analysis. JM will act as the guarantor for the
manuscript. BMM, ARM and RYS were involved in designing the study,
providing logistic support, supervising dispatch of samples, data
management and manuscript preparation.
Funding: Marico Industries Ltd. provided the
oils and placebo for the study.
Competing interests: Marico Industries Ltd. Is
involved in the production of coconut oil. BM, AM and RS Mohile are
employees of Marico Industries. None of the authors from Sion Hospital
have any shares in the company.