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Completed

NCT Number: NCT05403684

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

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).

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Key information

Conditions

Postnatal Growth Restriction Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

1 day–7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Teaching Hospital

Lusaka, 10101, Zambia

About this study

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. The study will enrol a total of 214 study participants including 190 preterm infants randomized controlled trial of HV feedings and 24 mothers of enrolled infants and healthcare workers for in-depth interviews. We will also screen mothers to study participants for postpartum depression using the Edinburgh Postnatal Depression Scale (EPDS) screening tool.

Study aims are:

Aim 1: To evaluate the impact of high volume (HV) feedings using additionally expressed milk at the end of feeding (hind-milk) vs usual volume (UV) feedings on growth velocity from birth to discharge or 40 weeks' PMA, whichever comes first, among very preterm infants.

Through a 1:1 randomization, the study will enrol 190 preterm infants weighing between 1,000g - 1,999g in both study arms and follow them until hospital discharge or 40 weeks' PMA, whichever comes first.

Aim 2: To evaluate the impact of HV vs UV breastfeeding until 40 weeks' PMA on all-cause neonatal mortality and morbidity (including sepsis, NEC, intestinal perforation, and hypoglycaemia).

All study participants (n=190) will be until 40 weeks' PMA to estimate its impact on all-cause neonatal mortality and morbidity.

Aim 3: To characterize the acceptability, feasibility, and feeding tolerance among HV breastfeeding women and their infants at the hospital and its feasibility by healthcare workers.

A total of 24 mothers and healthcare workers will be interviewed through in-depth interviews (IDIs) to better understand the acceptability of this intervention by the feeding mothers, the feeding tolerance by their newborns, and the feasibility of the same by the healthcare workers.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

High-volume breastmilk

Other

Preterm infants will be given high-volume breastmilk

Primary outcomes

  1. Weight gain

    Time frame: Baseline up to 40 weeks PMA.

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

Secondary outcomes

  1. Head circumference

    Time frame: Baseline up to 40 weeks PMA.

    Average change in head circumference (in centimetres using measuring tape) between enrolment (baseline) and 40 weeks post-menstrual age (PMA) or hospital discharge, whichever comes first.

  2. Mid-arm circumference

    Time frame: Baseline up to 40 weeks PMA.

    Average change in mid-arm circumference (in centimetres using measuring tape) between enrolment (baseline) and 40 weeks post-menstrual age (PMA) or hospital discharge, whichever comes first.

  3. Length

    Time frame: Baseline up to 40 weeks PMA.

    Average change in length (in centimetres using measuring tape) between enrolment (baseline) and 40 weeks post-menstrual age (PMA) or hospital discharge, whichever comes first.

  4. Length of hospital stay

    Time frame: Baseline up to 40 weeks PMA.

    Average change in length of hospital stay between enrolment (baseline) and 40 weeks post-menstrual age (PMA) or hospital discharge, whichever comes first.

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

    Time frame: Through study completion, on average 8 weeks after enrolment

    To characterize the acceptability, feasibility, and feeding tolerance among HV breastfeeding women and their infants at the hospital.

  6. Characterise feasibility of HV breastfeeding by healthcare workers (HCWs)

    Time frame: Through study completion, on average 8 weeks after enrolment

    To characterize the feasibility of HV breastmilk by mothers to the infants (patients) by HCWs

Other outcomes

  1. Neonatal mortality

    Time frame: 28 days after birth

    Newborn status at 28 days after birth

  2. Weight at 40 weeks PMA

    Time frame: 40 weeks PMA

    For infants discharged prior to 40 weeks PMA, their birthweight will be taken at 40 weeks PMA during study exit.

  3. Postpartum Depression

    Time frame: 6-8 weeks postnatal

    Maternal postpartum depression at at 6-8 weeks postnatally using Edinburgh Postnatal Depression Scale screening tool (scale ranges from 0-30, with 11+ indicative of depressive symptoms)

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Centre for Infectious Disease Research in Zambia
  • Chiesi Foundation

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jun 3, 2022
Registry last updated
Feb 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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