Trial on feeding for Low birth and premature babies

Phase 4

Conditions: Health Condition 1: P071- Other low birth weight newbornHealth Condition 2: P073- Preterm [premature] newborn [other]

Registration Number: CTRI/2023/12/060768

Lead Sponsor: Bill and Melinda Gates Foundation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

For RCT

1. Very LBW ( <1.5 kg) or very preterm ( <32 weeks) admitted to NICU at study facility <24 hours after birth for in-born infants and up to 48 hours for out-born (timing of admission may be extended to meet sample size goals)

2. Mother and infant alive during screening

3. Mother age 18+ years (India and Tanzania) or 16-18 and married (Malawi only)

4. Lives within catchment areas of the facility (50km)

5. Infant receiving at least 60 mL/kg/day of human milk

For Qualitative Research

1. Stakeholders with some familiarity with or expertise regarding the use of probiotics for very preterm infants within the study country

2. Key stakeholder consents for him/herself

Exclusion Criteria

For RCT

1. Lives outside the defined catchment area

2. Congenital abnormalities or acquired conditions that interfere with feeding or placement of NG/OG tube [cleft lip/palate, Toxoplasmosis, other agents, rubella, cytomegalovirus, and herpes (TORCH), Trisomy 21, Congenital cardiac defect, neural tube defect, gastrointestinal (GI) tract anomalies, hydrocephalus, NEC]

3. Severe birth asphyxia

4. Critically ill (i.e. not on enteral feeds)

5. Unknown date of birth and unknown gestational age

For Qualitative Research

N/A

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
For RCT <br/ ><br>Mean (Standard Deviation [SD]) Length-for-age Z score (LAZ) at 3 months <br/ ><br> <br/ ><br>For Qualitative Research <br/ ><br>1. Perceived acceptability & utility of probiotic interventions <br/ ><br>2. Feasibility of implementation of probioticsTimepoint: At 3 months of chronological age

Secondary Outcome Measures