Q. The Recommendations of the lAP Working Group on the Management of the newborn of a mother with active tuberculosis(1) differs somewhat from that of other authorities and hence has generated active debate. This communication is an attempt to look into the principles and controversies on this subject.

The mother invariably will be having reactivation tuberculosis and hence the disease will be localized to the lung. Unlike primary infection, blood borne dissemination is unlikely in reactivation tuberculosis and hence the fetus is unlikely" to be infected in utero. Thus congenital tuberculosis, which is the acquisition of infection in utero, is extremely rare. In most instance the newborn of mother with tuberculosis gets air borne infection after birth. Thus there is a school of thought that the child should be separated from mother soon after birth(2). However this is not practical in most Indian homes and it deprives the child of beneficial effects of breast-feeding. Hence the lAP rightly recommends. the breast feeding to be continued. In addition INH treatment for the newborn has been so effective that separation of the mother and child is not mandatory(2).

Many authorities recommend that such children must be given preventive treatment with INH even if the X-ray is normal(3). There is always a doubt that if the child is infected the bacilli may acquire resistance while on mono therapy with INH. As the infant most often gets infection post natally, the INH therapy can be considered as a "preventive therapy" started even before the organisms establish themselves. A resistant mutant occurs once every 10⁸ replications only(4). Here the treatment is started even before bacilli had a foothold and hence bacterial divisions of this magnitude is not possible. Thus the argument had been that there is no danger of resistant mutant even if INH was used as a single drug. Now the scenario has changed and there are organisms with primary drug resistance to INH in the community and hence the working group recommended 2 drugs (HR) even for preventive therapy. The chance of the bacilli being resistant to both INH and rifampicin is 10¹⁶. This number of organisms are not seen even in. adults with extensive cavities(4) and hence a 3rd drug is unnecessary.

Giving BCG at birth will not protect the child as it takes 1-3 months for its protective efficacy(1,3) by which time the organisms might have spread to various regions- a fact well known in primary infection. Hence there is need for additional preventive chemotherapy.

The standard recommendation is to give BCG after completion of chemo- therapy of appropriate duration(3). However, the Working Group recommends that BCG be given along with the start of chemotherapy which should in all probability kill the BCG organisms. The Working Group itself recommends INH for BCG adenitis thus recognizing it's potential to kill the BCG organisms. BCG being attenuated organism with limited capacity for division it is easy to tackle these and hence just a single drug therapy is enough. Thus, it is clear that simultaneous BCG and chemotherapy will inactivate the live BCG vaccine. There is no literature to show that killed BCG is effective. Attenuated organ- isms are not-known to remain dormant and alive for the whole period of treatment (If it is true the same should apply to the wild organisms making the disease flare up once the treatment is stopped!).

The convener of the Working Group asserts that BCG will provide the immunity and chemotherapy administered con-currently will prevent the natural infection(5). This does not stand to reason. However the Working Group must have reasons for their recommendation and I would be glad to update myself with relevant published works in this regard. On the other hand if this protocol has not been adequately field tested, the Working Group must consider revising their recommendation.
 

A. Santosh Kumar,
Assistant Professor,
Department of Pediatrics,
S.A.T. Medical College,
Thiruvananthapuram 695 011, India.

REFERENCES

1. Treatment of childhood tuberculosis: Consensus statement of lAP Working Group. Indian Pediatr 1997; 34: 1093- 1096.

2. Starke JR. Tuberculosis. In: Nelson Text Book of Pediatrics, 15th edn. Eds. Behrman RE, Kliegman RM, Arvin AM. Phildelphia, W.B. Saunders Company, 1996; pp 834-846. -

3. Tuberculosis in children. Guidelines for diagnosis, prevention and treatment (A statement of the scientific committees of the IUATLD). Bull Int Union Tuberc Lung Dis 1991; 66: 61-67.

4. Iseman MD. Treatment of multi drug resistant tuberculosis. N Engl J Med 1993; 329: 784-791.

5. Amdekar YK. Baby born to mother with tuberculosis. Indian Pediatr 1998; 35: 491- 494.

 

We have read with interest the letter by Yash Paul(1) and have considered carefully the points raised on the subject. In reply Amdekar(2) has stated. "It has been recommended to give BCG vaccine at birth to a baby born to mothers suffering from tuberculosis, along with chemoprohylaxis for 6 months even if the chest X-ray is normal. This is because such a baby may be infected or not. If not infected, chemoprophylaxis will prevent risk of maternal infection and BCG vaccine will provide immunity".

However, it is likely that the bactericidal drugs (RH) used in chemoprophylaxis will kill the live attenuated bacilli of the BCG vaccine administered, before it can evoke the desired immunity. In this context, we quote below some recent recommendations:

1. While the child is on treatment with isoniazid, BCG should not be given(3). Do not vaccinate with BCG at the same time as isoniazid is being administered(4).

2. Newborn infants born to mothers with sputum positive for acid fast bacilli should be on chemoprophylaxis until the mother's sputum becomes bacteriologically negative. Thereafter chemo- prophylaxis is stopped and BCG vaccination is given(5).

3. BCG should not be given during isoniazid prophylaxis because isoniazid inhibits multiplication of BCG(6).
All the above recommendations are on the use of isoniazid alone in chemoprophylaxis. The possible additive bactericidal effect of inclusion of rifampicin in the regimen in strengthening the above views should also be considered. Further clarification of this important issue is needed.

M.K. Das,
R.M.O. Cum Clinical Tutor,
Department of Pediatrics,
Bankura Saminilani Medical College, Bankura, (West Bengal), India,
N. Bhattacharyya,
Post-graduate Student (PSM),
All India Institute of Hygiene and
Public Health, Calcutta, India.

REFERENCES

1. Yash Paul. BCG vaccination with anti- tubercular therapy. Indian Pediatr 1998; 35: 493.

2. Amdekar YK. Reply. Indian Pediatr 1998; 35: 493-494.

3. Samu N, Subramanya L. BCG. In: Child- hood Tuberculosis: A Practical Approach, 1st edn. Madras, Sira and Co, 1991; p 38.

4. Crofton J, Horne N, Miller F. General guide to treatment: The newborn child. In: Clinical Tuberculosis, 1st Indian edn. ,New Delhi, CBS Publisher and Distributors, 1996; pp 152-153.

5. Ghai OP. Tuberculosis in childhood. In: Essential Pediatrics, 4th edn. New Delhi, Interprint Publishers, 1996; p 166.

6. Speck WT. Infants born to mothers with active tuberculosis.' In: Nelson Textbook of Pediatrics, 13th edn. Eds. Behrman RE, Vaughan VC, Nelson WE. Philadelphia, W.B. Saunders Company, 1987; pp 637- 638.

 

The lAP Working Group in its Consensus Statement on Treatment of Childh09d Tuberculosis has recommended use of BCG vaccine and two-drug chemoprophylaxis for a baby born to a mother suffering from active tuberculosis. This was formulated after due consideration of the following facts(1-4):

1. With increasing incidence of drug resistance, two-drug (HR) chemoprophylaxis has become essential.

2. At the end of three months of chemoprophylaxis, negative tuberculin reaction may not guarantee absence of natural infection or disease. Tuberculin negative tuberculosis is not rare. Therefore it is ideal to extend the duration of chemoprophylaxis for a period of six months. It provides adequate cover as a preventive therapy for the uninfected and a curative therapy for the infected. Hence the recommendation of 6HR.

3. Protective efficacy of BCG vaccine depends upon many variable factors including age at vaccination and chance of exposure to atypical Mycobacterial infection from the environment. Protective efficacy, may be reduced if vaccinated at 6 months of age than at birth. Ideally, vaccine should be used only in tuberculin negative older infant, thus necessitating tuberculin test. Thus ideal age for vaccination is at birth or as early as possibly after birth.

4. BCG vaccine given along with chemo- prophylaxis does induce immune response though may lessen the protective efficacy as compared to standard vaccination at birth without drug therapy.

5. In effect, protective efficacy of BCG vaccine is either way reduced - whether given after 6 months of age at the completion of therapy or given at birth along with chemotherapy. Thus, choice rests equally between the two modalities of management as both the methods sacrifice some benefits of BCG vaccination as compared to a standard dose.

6. Considerihg the simplicity of implementing a standard protocol, the Working Group suggested 6 HR drug therapy with BCG vaccine at birth. It entails no further tuberculin testing with its inherent problems and limitations of interpretation.
 

Y.K. Amdekar,
Convenor,
lAP Working Group of Tuberculosis,
Honorary Professor of Pediatrics,
Grant Medical College and J.J. Hospital,
Mumbai, India.
 

REFERENCES

1. Joshua B, Satya Sri S. Tuberculosis and Pregnancy. In: Textbook of Tuberculosis, 2nd edn. New Delhi, Interprint, 1995; p 103.

2. Seth V. BCG vaccination. In: Essentials of Tuberculosis in Children. New Delhi, Jaypee Brothers, 1997; p 42.

3. RF, Jacobs. Abernathy R. Management of tuberculosis in pregnancy and the newborn. Clin Perinatal 1988; 15:305-317.

4. Kendig EL. The place of BCG vaccine in the management of infants born to tuberculous mothers. N Engl J Med 1969; 281: 520-523.