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

NCT05403684 | Completed

• 1 other identifier: IRB-300007476
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

breastmilk; hindmilk; high-volume breastfeeding; postnatal growth restriction; preterm

Outcome Measures

Primary Outcomes (1)

• Weight gain

  Average change in weight between enrolment (baseline) up to 40 weeks post-menstrual age (PMA) or hospital discharge, whichever comes first.

  Baseline up to 40 weeks PMA.

Secondary Outcomes (6)

• Head circumference

  Baseline up to 40 weeks PMA.

• Mid-arm circumference

  Baseline up to 40 weeks PMA.

• Length

  Baseline up to 40 weeks PMA.

• Length of hospital stay

  Baseline up to 40 weeks PMA.

• Characterise acceptability, feasibility, and feeding tolerance by breastfeeding women and their infants

  Through study completion, on average 8 weeks after enrolment

Other Outcomes (3)

• Neonatal mortality

  28 days after birth

• Weight at 40 weeks PMA

  40 weeks PMA

• Postpartum Depression

  6-8 weeks postnatal

Study Arms (2)

Usual-volume breastfeeding (UV Group)

NO INTERVENTION

Infants will receive cup-feeding (to standardize the volume at each feeding) per standard of care guidelines (SOC: 140-180 mL/kg/day) with volumes adjusted for weight and infant age.

High-volume breastfeeding (HV Group)

EXPERIMENTAL

Along with SOC volume provided via cup-feeding, the mother will continue to express and feed the baby hind-milk reaching 240 mL/kg/day with volumes adjusted for weight and infant age (200-240 ml/kg/day).

Other: High-volume breastmilk

Interventions

High-volume breastmilk OTHER

Preterm infants will be given high-volume breastmilk

High-volume breastfeeding (HV Group)

Eligibility Criteria

• Age: 1 Day - 7 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Between 28 0/7 to 31 6/7 weeks of age or weighing between 1000-1999 grams,
• Admitted to the UTH NICU within 24 hours after birth, and
• Infants who have reached feeding volume ≥120 mL/kg/day at time of randomization

You may not qualify if:

• Who are deemed unstable by the neonatologist,
• With necrotizing enterocolitis or intestinal perforation
• Known gastrointestinal malformations,
• Major malformations or congenital anomalies, and
• Whose parents do not provide informed consent

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Centre for Infectious Disease Research in Zambia: collaborator
• Chiesi Foundation: collaborator

Study Sites (1)

University Teaching Hospital

Lusaka, 10101, Zambia

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Study Officials

• Waldemar Carlo, MD

  University of Alabama at Birmingham

  STUDY CHAIR

• Colm Travers, MD

  University of Alabama at Birmingham

  STUDY DIRECTOR

• Albert Manasyan, MD, MPH

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The proposed study is a non-blinded randomized controlled trial with a 1:1 parallel allocation of infants to higher-volume feedings (200-240 ml/kg/day) or usual-volume feedings (140-180 ml/kg/day) using computer-generated random-block sequences.

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: June 3, 2022
• Study Start: June 13, 2022
• Primary Completion: December 28, 2022
• Study Completion: February 10, 2023
• Last Updated: February 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available for sharing following publication of study findings (or during submission for publication if requested by the journal)
• Access Criteria: Following a reasonable request to the study PI.

Locations

ZA (1)