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Impact of Hindmilk on Weight Gain Among Moderate to Very Preterm Infants in Zambia

NCT05403684 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2023-02-14

No results posted yet for this study

Summary

The primary hypothesis is that very preterm infants between 28 0/7 to 31 6/7 weeks with a birth weight from 1000-1999 grams allocated to the HV breastmilk group (200-240 mL/kg/day) until hospital discharge or 40 weeks' post-menstrual age (PMA), whichever comes first, will have increased growth velocity compared to those given UV breastmilk (140-180 mL/kg/day).

Conditions

  • Postnatal Growth Restriction

Interventions

OTHER

High-volume breastmilk

Preterm infants will be given high-volume breastmilk

Sponsors & Collaborators

  • Centre for Infectious Disease Research in Zambia

    collaborator OTHER

  • Chiesi Foundation

    collaborator UNKNOWN

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Waldemar Carlo, MD · University of Alabama at Birmingham

  • Colm Travers, MD · University of Alabama at Birmingham

  • Albert Manasyan, MD, MPH · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
7 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-13
Primary Completion
2022-12-28
Completion
2023-02-10

Countries

  • Zambia

Study Locations

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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 NCT05403684 on ClinicalTrials.gov