CTRI/2023/12/060768
Recruiting
Phase 4
ow Birthweight and Preterm Infant Feeding Trial and Supportive Care Package (LIFT-UP) - LIFT-UP
Bill and Melinda Gates Foundation0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: P071- Other low birth weight newbornHealth Condition 2: P073- Preterm [premature] newborn [other]
- Sponsor
- Bill and Melinda Gates Foundation
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •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
Outcomes
Primary Outcomes
Not specified
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