Improving feeding and care for low birthweight and preterm infants
Low Birthweight and Preterm Infant Feeding Trial and Supportive Care Package (LIFT-UP): Implementation Research of an In-facility and Community Supportive Care Package in India, Malawi and Tanzania
This study is testing a new care and feeding program for low birthweight and preterm babies in neonatal units to see if it helps them grow better and supports their families after they go home.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 695 (estimated) |
| Ages | 1 Minute and up |
| Sex | All |
| Sponsor | Harvard School of Public Health (HSPH) Academic / other |
| Locations | 5 sites (Kanpur and 4 other locations) |
| Trial ID | NCT06390943 on ClinicalTrials.gov |
What this trial studies
The Low Birthweight and Preterm Infant Feeding Trial and Supportive Care Package aims to enhance feeding and growth outcomes for low birthweight or preterm infants in neonatal intensive care units across India, Malawi, and Tanzania. This study focuses on supporting maternal lactation, providing Kangaroo Mother Care, and ensuring proper water, sanitation, and hygiene practices. It also includes post-discharge feeding counseling to assist families in continuing care at home. The research employs a mixed-methods approach to evaluate the effectiveness and acceptability of these interventions.
Who should consider this trial
Good fit: Ideal candidates for this study are low birthweight or preterm infants admitted to NICUs within 24 hours of birth, along with their consenting mothers.
Not a fit: Patients with congenital anomalies or conditions that interfere with feeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the health and growth outcomes of low birthweight and preterm infants.
How similar studies have performed: Other studies have shown success with similar approaches in improving outcomes for low birthweight and preterm infants, indicating a promising avenue for this research.
Eligibility criteria
Show full inclusion / exclusion criteria
OBJECTIVE 1 (FACILITY-BASED) Inclusion criteria Infants * Low birthweight (≤2.5kg) or preterm (\<37 weeks) infants admitted to NICU at study facility * In-born infants admitted to the NICU within 24 hours of birth) * Mother and infant alive during screening * Mother consents for herself and infant * Women (mothers) who are age of majority: Tanzania and India: 18+; Malawi: 16-17 and married OR 18+ Healthcare providers * Healthcare provider who was trained to deliver the facility-based FSP+ * Healthcare provider consents for him/herself Exclusion criteria Infants * Out-born infants referred to study facility NICU * Congenital anomalies or acquired conditions that interfere with feeding or placement of nasogastric/ orogastric (NG/OG) tube \[e.g., cleft lip/palate, toxoplasmosis,other agents, rubella, cytomegalovirus, and herpes (TORCH), Trisomy 21, Congenital cardiac defect, neural tube defect, gastrointestinal (GI) tract anomalies, hydrocephalus, necrotizing enterocolitis\] * Severe birth asphyxia * Unknown date of birth and unknown gestational age OBJECTIVE 2 (TRANSITION-TO-HOME) Inclusion criteria Infants * Infants in India-Uttar Pradesh site * LBW (\<2.5kg) or preterm (\<37 weeks) infants discharged from a study facility and fulfilling all objective 1 inclusion criteria (exposed to objective 1 intervention) * Lives within catchment areas of study facility (50km) * Mother intends to stay in the catchment areas for 3 months post-birth with infant Community providers * Community provider who was trained to deliver the transition-to-home FSP+. * Community provider consents for him/herself Exclusion criteria Infants * Not screened and was not exposed to objective 1 intervention (and meet all eligibility criteria) * Lives outside the defined catchment area * Mother does not intend to stay in the catchment areas for 3 months post-birth with infant Community providers -Community provider who was not trained to deliver the transition-to-home FSP+.
Where this trial is running
Kanpur and 4 other locations
- Ganesh Shankar Vidyarthi Memorial Medical College — Kanpur, India (Recruiting)
- King George Medical College — Lucknow, India (Recruiting)
- Institute of Medical Sciences, Banaras Hindu University — Varanasi, India (Recruiting)
- Bwaila District Hospital — Lilongwe, Malawi (Recruiting)
- Amana Regional Hospital — Dar Es Salaam, Tanzania (Recruiting)
Study contacts
- Principal investigator: Katherine Semrau, PhD, MPH — Ariadne Labs
- Study coordinator: Ilana Dzuba, MHS
- Email: idzuba@ariadnelabs.org
- Phone: (617) 384-6555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.