Health Condition 1: null- Very premature infants if they meet the following inclusion criteria: gestational age 26-31 completed weeks at birth
Conditions
Interventions
Intervention1: Colostrum: A measured 0.2 mL of colostrum or placebo will be administered via the oropharyngeal route.
Control Intervention1: Sterile water: A measured 0.2 mL of colostrum or placebo wi
Sponsors
JIPMER
Eligibility
Inclusion criteria
Inclusion criteria: Very premature infants if they meet the following inclusion criteria: gestational age 26-31completed weeks at birth; mother plans to provide milk; NICU admission <= 12 hours of life.
Exclusion criteria
Exclusion criteria: Birth asphyxia (cord pH/first hour arterial pH < 7.0 or chest compressions); presence of major congenital anomalies or chromosomal disorders; HIV positive mother; maternal age less than 18 years; maternal drug or substance abuse that precludes infant from receiving motherâ??s milk; suspected inborn error of metabolism; lack of parental consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the effect of oropharyngeal administration of colostrum versus placebo, on(1) a composite of death, late-onset sepsis or necrotizing enterocolitis in the neonatal period.Timepoint: 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of death, necrotizing enterocolitis, late-onset sepsis, clinical sepsis, intraventricular hemorrhage, ventilator-associated pneumonia, retinopathy of prematurity and broncho pulmonary dysplasia; time to full feeds; time to regain birth weight; duration of hospital stay; and survival without major neurosensory impairment at 6 months.Timepoint: 6 months | — |
Countries
India
Contacts
Public ContactRahul Aggarwal
JIPMER, Puducherry
Outcome results
None listed