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

NCT ID: NCT05403684

Last Updated: 2023-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 214 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-13
• Study Completion Date: 2023-02-10

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).

Detailed Description

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.

Conditions

Postnatal Growth Restriction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Usual-volume breastfeeding (UV Group)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

High-volume breastfeeding (HV Group)

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).

Group Type: EXPERIMENTAL

High-volume breastmilk

Intervention Type: OTHER

Preterm infants will be given high-volume breastmilk

Interventions

High-volume breastmilk

Preterm infants will be given high-volume breastmilk

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 7 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre for Infectious Disease Research in Zambia

OTHER

Sponsor Role: collaborator

Chiesi Foundation

UNKNOWN

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Albert Manasyan, MD, MPH

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Waldemar Carlo, MD

Role: STUDY_CHAIR

University of Alabama at Birmingham

Colm Travers, MD

Role: STUDY_DIRECTOR

University of Alabama at Birmingham

Albert Manasyan, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University Teaching Hospital

Lusaka, , Zambia

Countries

Zambia

Other Identifiers

IRB-300007476

Identifier Type: -

Identifier Source: org_study_id