Impact of Hindmilk on Weight Gain Among Moderate to Very Preterm Infants in Zambia
Condition: Postnatal Growth Restriction
MeSH terms: Weight Gain
Study type: Interventional

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.
    

Intervention name(s): High-volume breastmilk
Intervention type(s): Other
Intervention description(s): Preterm infants will be given high-volume breastmilk
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: breastmilk; hindmilk; high-volume breastfeeding; postnatal growth restriction; preterm