A study to compare differences in neurological outcome after two different approaches to feeding support in preterm babies with slow growth.
Phase 2
- Conditions
- Health Condition 1: P073- Preterm [premature] newborn [other]
- Registration Number
- CTRI/2023/11/059743
- Lead Sponsor
- Indian Council of Medical Research (ICMR)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Birth gestational age <33 completed weeks.
2. Postnatal weight >1 z score below the birth z score between 10 days of age and 36 weeks postmenstrual age
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Major neurodevelopmental disability at 18-20 months corrected age, defined as one or more of the following: <br/ ><br>1. Bayley-4 standard score less than 70 in Cognitive or Motor or Language domain. <br/ ><br>2. Cerebral palsy GMFCS more than class I. <br/ ><br>3. Hearing loss requiring hearing aid. <br/ ><br>4. Blindness (vision of less than 3/60 in the better eye) <br/ ><br>Timepoint: 18 to 20 months corrected age. <br/ ><br>
- Secondary Outcome Measures
Name Time Method 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