Clinical trial NCT05403684: Impact of Hindmilk on Weight Gain Among Moderate to Very Preterm Infants in Zambia
Official title: Impact of Hindmilk on Weight Gain Among Moderate to Very Preterm Infants in Zambia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postnatal Growth Restriction
Keywords: breastmilk
hindmilk
high-volume breastfeeding
postnatal growth restriction
preterm
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Centre for Infectious Disease Research in Zambia
name: Chiesi Foundation
First posted: 2022-06-03
Enrollment: 214
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Weight gain
timeFrame: Baseline up to 40 weeks PMA.
Secondary outcomes:
measure: Head circumference
timeFrame: Baseline up to 40 weeks PMA.
measure: Mid-arm circumference
timeFrame: Baseline up to 40 weeks PMA.
measure: Length
timeFrame: Baseline up to 40 weeks PMA.
measure: Length of hospital stay
timeFrame: Baseline up to 40 weeks PMA.
measure: Characterise acceptability, feasibility, and feeding tolerance by breastfeeding women and their infants
timeFrame: Through study completion, on average 8 weeks after enrolment
measure: Characterise feasibility of HV breastfeeding by healthcare workers (HCWs)
timeFrame: Through study completion, on average 8 weeks after enrolment
Other outcomes:
measure: Neonatal mortality
timeFrame: 28 days after birth
measure: Weight at 40 weeks PMA
timeFrame: 40 weeks PMA
measure: Postpartum Depression
timeFrame: 6-8 weeks postnatal
Locations:
city: Lusaka
country: Zambia
facility: University Teaching Hospital
Study officials:
affiliation: University of Alabama at Birmingham
name: Waldemar Carlo, MD
role: STUDY_CHAIR
affiliation: University of Alabama at Birmingham
name: Colm Travers, MD
role: STUDY_DIRECTOR
affiliation: University of Alabama at Birmingham
name: Albert Manasyan, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: