Health Condition 1: P073- Preterm [premature] newborn [other]
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Premature infants born less than 32 weeks gestational age and/or Birth Weight less than 1500 grams On human milk At 2 weeks of age , tolerating 150ml/kg/day of enteral feeds
Exclusion criteria
Exclusion criteria: Parents do no consent. Confounders for poor growth such as congenital heart disease, GI diagnoses such as gastroschisis and omphalocele, and or major congenital anomalies Grade III or IV intraventricular hemorrhage diagnoses prior to randomization Failure to initiate fortified feeds prior to 3 weeks of life Diagnosis of necrotizing entercolitis prior to randomization Diagnosis of early onset sepsis confirmed with positive culture
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight : Percentile; z score Weight gain (g/kg/day) change in z-score from week-to-week Length : Percentile; z score Gain in length (cm/week) change in z-score from week-to-week Head Circumference: Head circumference change in cm/week, z-score value, and change in z-score from week-to-week. Head Circumference: Head circumference change in cm/week, z-score value, and change in z-score from week-to-week. Timepoint: Baseline at 1 week at 4 weeks at Discharge | — |
Secondary
| Measure | Time frame |
|---|---|
| Total Number of Days of Length of Stay in NICU Rate of Mortality Number of Feeding Intolerance Events defined as 1 or more feeds held. Number of Necrotizing Enterocolitis Events Incidence of Bronchopulmonary dysplasia Incidence of supplemental oxygen requirement at 36 weeks corrected gestational age. Incidence of Retinopathy of prematurity Timepoint: From 2 weeks of age till discharge | — |
Countries
India
Contacts
Chettinad Hospital And Research Institute