Benefit of oral colostrum in very preterm infants: A trial
Not Applicable
Completed
- Conditions
- Health Condition 1: null- Very premature infants if they meet the following inclusion criteria: gestational age 26-31 completed weeks at birth
- Registration Number
- CTRI/2017/11/010396
- Lead Sponsor
- JIPMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 260
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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