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Low-birthweight Infant Feeding Exploration

NCT04002908 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3188

Last updated 2025-04-27

Study results available
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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

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Emory University

    collaborator OTHER

  • Boston Children's Hospital

    collaborator OTHER

  • Brigham and Women's Hospital

    collaborator OTHER

  • PATH

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    collaborator OTHER

  • Jawaharlal Nehru Medical College

    collaborator OTHER

  • Muhimbili University of Health and Allied Sciences

    collaborator OTHER

  • University of North Carolina

    collaborator OTHER

  • Ariadne Labs

    collaborator OTHER

  • Harvard School of Public Health (HSPH)

    lead OTHER

Principal Investigators

  • Katherine Semrau, PhD, MPH · Ariadne Labs

Eligibility

Min Age
16 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-31
Primary Completion
2021-07-29
Completion
2021-07-29

Countries

  • India
  • Malawi
  • Tanzania

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04002908 on ClinicalTrials.gov