Health Condition 1: P071- Other low birth weight newborn Health Condition 2: P073- Preterm [premature] newborn [other]
Conditions
Interventions
Intervention1: Fortification of human milk with Lactodex: Dosage: Powdered HMF will be added to the cup with the human milk (either MOM or PDHM if available) per the manufacturers specifications-One g
Sponsors
Bill and Melinda Gates Foundation
Eligibility
Inclusion criteria
Inclusion criteria: For RCT 1. Very LBW ( 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For RCT Mean (Standard Deviation [SD]) Length-for-age Z score (LAZ) at 3 months For Qualitative Research 1. Perceived acceptability & utility of probiotic interventions 2. Feasibility of implementation of probioticsTimepoint: At 3 months of chronological age | — |
Secondary
| Measure | Time frame |
|---|---|
| For RCT Mean (SD) length of stay from randomization to facility discharge Feeding intolerance between randomization & facility discharge (yes/no) Weight growth velocity (attaining 15 g/kg/d) from randomization to facility discharge (yes/no) Mean (SD) weight growth velocity between randomization & facility discharge Mean (SD) length gain (mm per wk) from randomization to facility discharge Mean (SD) head circumference gain (mm per wk) from randomization to facility discharge NEC from randomization to facility discharge (yes/no) Sepsis/ possible serious bacterial infection (PSBI) from randomization to facility discharge (yes/no) Infant mortality from randomization to facility discharge (yes/no)Timepoint: Randomization to facility discharge;For RCT Birthweight regain by 2 weeks (yes/no)Timepoint: 2 weeks of age;For RCT Mean (SD) weight growth velocity from randomization to 4 weeks Neonatal mortality from randomization to 4 weeks (yes/no) Sepsis/PSBI from randomization to 4 weeks (yes/no)Timepoint: 4 weeks of age;For RCT Mean (SD) weight-for-age Z score (WAZ) at 3 months Mean (SD) weight-for-length Z score (WLZ) at 3 months Mean (SD) head circumference-for-age Z score (HcAZ) Change in WAZ between randomization & 3 months Change in LAZ between randomization & 3 monthsTimepoint: 3 months of age;For Qualitative Research Facilitators/benefits & barriers/risk of introducing probiotics Existing use of probiotics or similar interventions & successes/failures Regulatory & administrative requirements for new intervention use & associated policy change Risks mitigation Supply chain & impact of availability of electricity, transportation issues, & seasonality Guideline review processes Required infrastructure/support for implementation (e.g., water, sanitation, & hygiene (WASH), policy, guideline changes)Timepoint: Over the study period | — |
Countries
India, Malawi, Tanzania
Contacts
Public ContactDr Roopa M Bellad
J N Medical College KAHER Belagavi
Outcome results
None listed