Rahul Aggarwal1,2, Nishad Plakkal2, Vishnu Bhat2,3. 1. Department of Neonatology, Apollo Cradle, Gurgaon, India. 2. Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India. 3. Department of Neonatology, Division of Research, Aarupadai Veedu Medical College and Hospital, Vinayaka Mission's Research Foundation, Pondicherry, India.
Abstract
AIM: To evaluate whether a strategy of oropharyngeal administration of colostrum reduces morbidity and mortality in very preterm infants. METHODS: A total of 260 neonates with gestational age 26-31 weeks at birth were randomised between August 2017 and August 2018 to receive0.2 mL of human milk or placebo respectively via the oropharyngeal route, beginning within 24 h after birth, and continued every 3 h until oral feeds were initiated. The primary outcome was a composite of death, late-onset sepsis (LOS) or necrotising enterocolitis (NEC) in the neonatal period. RESULTS: A total of 260 infants (mean gestational age 29.5 weeks, and mean birthweight 1201.7 g) were included in the primary analysis. The composite primary outcome occurred in 43 (33.6%) infants in the colostrum group and 38 infants (29.7%) in the placebo group, and the difference was not statistically significant (P = 0.50). Secondary outcomes including the incidence of death, NEC, LOS, probable sepsis, intraventricular haemorrhage, ventilator-associated pneumonia, retinopathy of prematurity, bronchopulmonary dysplasia, time to full feeds, time to regain birthweight, duration of hospital stay and survival to 6 months without major neurosensory impairment were also comparable between the two groups. CONCLUSION: A strategy of oropharyngeal administration of colostrum in very preterm and extremely preterm neonates did not decrease the composite primary outcome of death, LOS or NEC. This finding is consistent with most published literature in the area.
RCT Entities:
AIM: To evaluate whether a strategy of oropharyngeal administration of colostrum reduces morbidity and mortality in very preterm infants. METHODS: A total of 260 neonates with gestational age 26-31 weeks at birth were randomised between August 2017 and August 2018 to receive 0.2 mL of human milk or placebo respectively via the oropharyngeal route, beginning within 24 h after birth, and continued every 3 h until oral feeds were initiated. The primary outcome was a composite of death, late-onset sepsis (LOS) or necrotising enterocolitis (NEC) in the neonatal period. RESULTS: A total of 260 infants (mean gestational age 29.5 weeks, and mean birthweight 1201.7 g) were included in the primary analysis. The composite primary outcome occurred in 43 (33.6%) infants in the colostrum group and 38 infants (29.7%) in the placebo group, and the difference was not statistically significant (P = 0.50). Secondary outcomes including the incidence of death, NEC, LOS, probable sepsis, intraventricular haemorrhage, ventilator-associated pneumonia, retinopathy of prematurity, bronchopulmonary dysplasia, time to full feeds, time to regain birthweight, duration of hospital stay and survival to 6 months without major neurosensory impairment were also comparable between the two groups. CONCLUSION: A strategy of oropharyngeal administration of colostrum in very preterm and extremely preterm neonates did not decrease the composite primary outcome of death, LOS or NEC. This finding is consistent with most published literature in the area.