A Randomized Controlled Trial of Oral Immunotherapy Therapy with Colostrum or Breast milk and Clinical Outcomes among Preterm Babies.

Background: Extreme Low birth infants are vulnerable to a series of morbidities like LOS, CLD, IVH, NEC which result in prolonged hospitalization. The value of breastmilk in reducing the severity of these morbidities have been studied. The use of mothers’ own colostrum early after birth by oropharyngeal route in small frequent doses is suggested to have immunomodulatory effect through OLFAT and possible reduction in morbidities.Objective: The study is a single centre, double blinded randomized controlled trial to assess the effectiveness of oral therapy with colostrum or breast milk on clinical outcomes in preterm babies less than 33 weeks’ gestation. Methods: 48 babies were randomly assigned to receive 0.2 ml of own mother’s colostrum, breast milk; or sterile water by oropharyngeal route every 4 hours, until independent feeding at breast or bottle was achieved. Eligibility included inborn preterm babies less than 33 weeks and below 1500 grams. Exclusion criteria were congenital anomalies, congenital viral infection, out born babies, babies of single mothers with unknown partners (mothers were incarcerated based on the country’s laws and breast milk was unavailable), confirmed immunodeficiency disorder, inborn error of metabolism, parental refusal to participate, and preterm babies with overt bleeding.The clinical outcomes studied were NEC, Culture-proven LOS, IVH, ROP, CLD, Jaundice requiring phototherapy, mortality, age at discharge home and length of hospital stay. Results: OIT with colostrum or Breastmilk did not show a statistical improvement in the clinical outcomes between the two groups or length of hospital stay. Conclusion: Oral therapy with colostrum is an alternative method of providing mothers’ milk for neonates who are kept nil per oral that could allow mothers to engage in the infants’ care in the early critical period of their life.