Postnatal Growth Restriction
Conditions
Keywords
breastmilk, hindmilk, high-volume breastfeeding, postnatal growth restriction, preterm
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.
Interventions
OTHERHigh-volume breastmilk
Preterm infants will be given high-volume breastmilk
Sponsors
Centre for Infectious Disease Research in Zambia
Chiesi Foundation
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
1 Days to 7 Days
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight gain | 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
| Measure | Time frame | Description |
|---|---|---|
| Length | 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. |
| Length of hospital stay | 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. |
| Characterise acceptability, feasibility, and feeding tolerance by breastfeeding women and their infants | 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. |
| Characterise feasibility of HV breastfeeding by healthcare workers (HCWs) | Through study completion, on average 8 weeks after enrolment | To characterize the feasibility of HV breastmilk by mothers to the infants (patients) by HCWs |
| Head circumference | 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. |
| Mid-arm circumference | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Postpartum Depression | 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) |
| Neonatal mortality | 28 days after birth | Newborn status at 28 days after birth |
| Weight at 40 weeks PMA | 40 weeks PMA | For infants discharged prior to 40 weeks PMA, their birthweight will be taken at 40 weeks PMA during study exit. |
Countries
Zambia
Outcome results
None listed