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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Low Birthweight and Preterm Infant Feeding Trial and Supportive Care Package (LIFT-UP) aims to improve feeding and growth outcomes among low birthweight (LBW; \<2.5kg) or preterm (\<37 weeks gestational age) infants admitted to neonatal intensive care units (NICU) in India, Malawi, and Tanzania by (1) supporting the initiation, establishment, and maintenance of maternal lactation and prioritized provision of human milk, Kangaroo Mother Care (KMC) and appropriate water, sanitation and hygiene (WASH) practices; and (2) facilitating feeding counseling at home post-discharge from the facility.

Eligibility
Participation Requirements
Sex: All
Minimum Age: Newborn
Healthy Volunteers: t
View:

⁃ 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

⁃ 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

Locations
Other Locations
India
Ganesh Shankar Vidyarthi Memorial Medical College
RECRUITING
Kanpur
King George Medical College
RECRUITING
Lucknow
Institute of Medical Sciences, Banaras Hindu University
RECRUITING
Varanasi
Malawi
Bwaila District Hospital
RECRUITING
Lilongwe
United Republic of Tanzania
Amana Regional Hospital
RECRUITING
Dar Es Salaam
Contact Information
Primary
Ilana Dzuba, MHS
idzuba@ariadnelabs.org
(617) 384-6555
Backup
Linda Vesel, PhD, MPH
lvesel@ariadnelabs.org
(617) 384-6555
Time Frame
Start Date: 2024-05-08
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 695
Treatments
Other: Obj 1 Infants receiving facility-based FSP+; Obj 2 infants receiving transition-to-home FSP+
Related Therapeutic Areas
Sponsors
Collaborators: PATH, Muhimbili University of Health and Allied Sciences, University of North Carolina, Emory University, Boston Children's Hospital, Brigham and Women's Hospital, Community Empowerment Lab, Jawaharlal Nehru Medical College
Leads: Harvard School of Public Health (HSPH)

This content was sourced from clinicaltrials.gov