Impact of Hindmilk on Weight Gain Among Moderate to Very Preterm Infants in Zambia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 214
- 试验地点
- 2
- 主要终点
- Weight gain
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Weight gain
时间窗: 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.
次要结局
- Length(Baseline up to 40 weeks PMA.)
- Head circumference(Baseline up to 40 weeks PMA.)
- Length of hospital stay(Baseline up to 40 weeks PMA.)
- Characterise feasibility of HV breastfeeding by healthcare workers (HCWs)(Through study completion, on average 8 weeks after enrolment)
- Mid-arm circumference(Baseline up to 40 weeks PMA.)
- Characterise acceptability, feasibility, and feeding tolerance by breastfeeding women and their infants(Through study completion, on average 8 weeks after enrolment)
研究者
Albert Manasyan, MD, MPH
Associate Professor
University of Alabama at Birmingham