Health Condition 1: P073- Preterm [premature] newborn [other]
Conditions
Interventions
Intervention1: Aggressive threshold: Initiation of nutritional interventions when the postnatal weight z-score drops 1 z-score below the birth z-score. The study is pragmatic, and the exact duration a
Sponsors
Indian Council of Medical Research (ICMR)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Birth gestational age 2. Postnatal weight >1 z score below the birth z score between 10 days of age and 36 weeks postmenstrual age
Exclusion criteria
Exclusion criteria: 1. Major congenital anomalies or genetic conditions. 2. Infants on comfort care who are not expected to survive. 3. NICU admission after 48 hours of age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major neurodevelopmental disability at 18-20 months corrected age, defined as one or more of the following: 1. Bayley-4 standard score less than 70 in Cognitive or Motor or Language domain. 2. Cerebral palsy GMFCS more than class I. 3. Hearing loss requiring hearing aid. 4. Blindness (vision of less than 3/60 in the better eye) Timepoint: 18 to 20 months corrected age. | — |
Secondary
| Measure | Time frame |
|---|---|
| Bronchopulmonary dysplasiaTimepoint: First hospital discharge;DeathTimepoint: 18-20 months;Death before dischargeTimepoint: First hospital discharge;HypertensionTimepoint: 18-20 months;MicrocephalyTimepoint: 18-20 months;Necrotizing enterocolitis Stage 2 or higherTimepoint: First hospital discharge;Neonatal deathTimepoint: 28 days;OverweightTimepoint: 18-20 months;Retinopathy of prematurity requiring treatmentTimepoint: 18 months;UnderweightTimepoint: 18-20 months | — |
Countries
India
Contacts
Public ContactNishad Plakkal
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
Outcome results
None listed