Low-birthweight Infant Feeding Exploration

NCT04002908 | Completed Results

• 1 other identifier: HSPH OPP1192260
• Study Type: observational
• Target: 3,188
• Locations: 3 countries
• Sites: 3

Brief Summary

Globally, 15% of all babies, amounting to 20 million infants each year, are born low birthweight (LBW), defined less than 2500 grams (5.5 lbs). Compared to normal weight infants, LBW infants are at higher risk of morbidity, mortality, and poor growth (Risnes et al 2011; Larroque et al 2001; WHO 2006). The main causes of LBW are preterm birth, intrauterine growth restriction (IUGR), or their combination. Unfortunately, there is a paucity of information around feeding practices and optimal feeding strategies for this population, particularly for LBW infants who struggle with breastfeeding or growth. This study hopes to address these gaps.

Conditions

Low Birthweight; Pre-Term

Keywords

Infant Health; Low and Middle Income Countries [LMIC]; Maternal Health; Infant Feeding; Low Birthweight

Outcome Measures

Primary Outcomes (2)

• Length-for-Age Z-score

  A Child's length-for-age z-score at 6 months of age. Length-for-age z-scores (LAZ) are based on World Health Organization (WHO) child growth standards for term infants and INTERGROWTH-21st standards were used for preterm infants. A LAZ Z-score of 0 represents the population mean and scores below 0 represent a worse outcome. Further, Z-scores less than -2.0 indicates stunting in the infant.

  At 6 month of age

• Length-for-Age Z-score

  A Child's length-for-age z-score at 12 months of age. A Child's length-for-age z-score at 12 months of age. Length-for-age (LAZ) z-scores were based on World Health Organization (WHO) growth standards for term infants and preterm infants; we corrected for gestational age (GA) for preterm infants. A LAZ z-score of 0 represents the population mean and scores below 0 represent a worse outcome. Further, Z-scores less than -2.0 indicates an infant who is underweight.

  At 12 month of age

Secondary Outcomes (1)

• Incidence of Diarrheal Disease

  6 month postpartum

Other Outcomes (4)

• Weight-for-age Z-score

  At 6 month of age

• Percentage of Infants Malnourished at 6 Months

  6 months of age

• Percentage of Infants Malnourished at 12 Months

  12 months of age

Study Arms (5)

In-facility Observations

Mothers and their LBW babies will be observed starting within 6 hours of birth until the baby is discharged from the health facility.

Prospective cohort study - Quantitative

Mothers and their low-birth weight babies will be enrolled 72 hours after birth and followed through 12 months postpartum. The prospective cohort survey (which includes anthropometric measurements and feeding observations) occurs at multiple time points over this 12-month period.

Prospective cohort study - Qualitative

Research specialists at each site will be speaking to key informants (includes doctors, nurses, midwives, community health workers (CHWs), Ministry of Health (MOH) officials, supply chain \& milk bank experts) who are knowledgeable about breastfeeding policy, supply chain, or milk banks. Clinicians in study health facilities who work on labor and delivery, postnatal, newborn and neonatal ICU wards. They participate in In-depth interviews. Mothers, family members and health care workers of LBW babies, as well as community leaders (including religious leaders) who are knowledgeable about infant feeding in their communities will participate in focus group discussions. Focus group discussion will take up to 2 hours. In-depth interviews will take up to 1 hour. Mothers (6-month extension): Mothers chosen and consented for in-depth interviews (IDIs) will include those currently enrolled in the prospective cohort. Additionally, their infants need to be between 9 and 12 months of age.

Retrospective Chart review

The retrospective chart review is a review of secondary data of mothers and their LBW babies who were born in the study health facilities prior to the start of the study.

Donor Human Milk Readiness Assessment

Key stakeholders in the area of newborn health who determine policy and procedures or who are directly involved with the provision of care. This includes clinicians, nurses, lactation/nutrition specialists, hospital leadership and/or Ministry of Health officials present in the study health facilities. This is a one-time data collection exercise in the form of either: (1) a largely qualitative facility readiness assessment tool with some qualitative questions for facility staff or (2) a facility tool observing the "flow of milk" along with key informant interviews in the study facilities. This could take anywhere from 1hr to a day depending on the tool administered, key informants involved and size of the study facility.

Eligibility Criteria

• Age: 16 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Mothers and their LBW babies who are either born in the study health facilities or arrive within 72 hours of birth and meet eligibility criteria

You may qualify if:

• Infant birthweight between 1500 and \<2500g (according to chart and then verified by study staff).
• Residence within catchment area of facility.
• Mother's consent obtained for herself and infant.
• Newborns must be enrolled within 72 hours of birth.
• Women (mothers) who are of age of majority in their respective countries.

You may not qualify if:

• Mother does not meet the local age of majority.
• Infant very low birthweight \<1500g.
• Infant has congenital abnormality that interferes with feeding, which includes: Cleft lip or palate; Hydrocephalus; Gastrointestinal tract anomalies including gastroschisis, omphalocele, or anal atresia; Neural tube defects; Congenital cardiac defects; Suspected Trisomy 21; Suspected TORCH infection such as congenital rubella, cytomegalovirus (CMV), toxoplasmosis, or syphilis.
• Critical or severe illness jeopardizing early survival, specifically, investigators will exclude infants with severe encephalopathy as determined by modified Sarnat criteria.
• If the Infant dies before enrollment can occur.
• Infant has a twin or triplet that has died.
• Plans to leave the study area before end of data collection.
• Infants must be enrolled in the prospective study within 72 hours of birth. If the infant is older than 72 hours at the time of screening, s/he will be ineligible for the study.
• Maternal death: The study will exclude cases of maternal death that occur during labor and delivery (or at any time before the consenting process would begin for this study).
• Month Extension Study Criteria:
• Mother's or surrogate consent obtained for herself and infant for another 6 months of follow up.

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead
• Bill and Melinda Gates Foundation: collaborator
• Emory University: collaborator
• Boston Children's Hospital: collaborator
• Brigham and Women's Hospital: collaborator
• PATH: collaborator
• University of North Carolina, Chapel Hill: collaborator
• Jawaharlal Nehru Medical College: collaborator
• Muhimbili University of Health and Allied Sciences: collaborator
• University of North Carolina: collaborator
• Ariadne Labs: collaborator

Study Sites (3)

Jawaharlal Nehru Medical College

Belagavi, India

Location

UNC Project Malawi (UNCPM)

Lilongwe, Malawi

Location

Muhas/ Hsph

Dar es Salaam, Tanzania

Location

Related Publications (3)

• Mvalo T, Dhaded SM, Manji KP, Vesel L, Semrau KEA, Kisenge R, Somji S, Chiume M, Saidi F, Hoffman IF, Vernekar S, Bellad R, Koppad B, Tuller DE, Mokhtar R, Lee ACC, North K, Sudfeld CR. Mortality, morbidity and growth among moderately low birthweight infants in India, Malawi, and Tanzania. BMC Pediatr. 2025 Apr 23;25(1):316. doi: 10.1186/s12887-025-05668-8.

  PMID: 40264138 DERIVED

• Vesel L, Bellad RM, Manji K, Saidi F, Velasquez E, Sudfeld CR, Miller K, Bakari M, Lugangira K, Kisenge R, Salim N, Somji S, Hoffman I, Msimuko K, Mvalo T, Nyirenda F, Phiri M, Das L, Dhaded S, Goudar SS, Herekar V, Kumar Y, Koujalagi MB, Guruprasad G, Panda S, Shamanur LG, Somannavar M, Vernekar SS, Misra S, Adair L, Bell G, Caruso BA, Duggan C, Fleming K, Israel-Ballard K, Fishman E, Lee ACC, Lipsitz S, Mansen KL, Martin SL, Mokhtar RR, North K, Pote A, Spigel L, Tuller DE, Young M, Semrau KEA; LIFE study team. Feeding practices and growth patterns of moderately low birthweight infants in resource-limited settings: results from a multisite, longitudinal observational study. BMJ Open. 2023 Feb 15;13(2):e067316. doi: 10.1136/bmjopen-2022-067316.

  PMID: 36792338 DERIVED

• Vesel L, Spigel L, Behera JN, Bellad RM, Das L, Dhaded S, Goudar SS, Guruprasad G, Misra S, Panda S, Shamanur LG, Vernekar SS, Hoffman IF, Mvalo T, Phiri M, Saidi F, Kisenge R, Manji K, Salim N, Somji S, Sudfeld CR, Adair L, Caruso BA, Duggan C, Israel-Ballard K, Lee AC, Martin SL, Mansen KL, North K, Young M, Benotti E, Marx Delaney M, Fishman E, Fleming K, Henrich N, Miller K, Subramanian L, Tuller DE, Semrau KE. Mixed-methods, descriptive and observational cohort study examining feeding and growth patterns among low birthweight infants in India, Malawi and Tanzania: the LIFE study protocol. BMJ Open. 2021 Dec 2;11(12):e048216. doi: 10.1136/bmjopen-2020-048216.

  PMID: 34857554 DERIVED

Related Links

• Harvard Dataverse with LIFE study data available.

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: Katherine Semrau
• Organization: Ariadne Labs

ksemrau@ariadnelabs.org

6177805311

Study Officials

• Katherine Semrau, PhD, MPH

  Ariadne Labs

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of BetterBirth Program at Ariadne Labs; Assistant Professor

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: July 1, 2019
• Study Start: July 31, 2019
• Primary Completion: July 29, 2021
• Study Completion: July 29, 2021
• Last Updated: April 27, 2025
• Results First Posted: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available 12 months after study completion and available indefinitely.
• Access Criteria: Those who wish to use the dataset must register for access through Harvard Dataverse. There are no fees or charges associated with data access.

Locations

IN (1); TA (1); MA (1)