Long term neurodevelopmental outcome in Very Low Birth Weight (VLBW) preterm infants receiving post-discharge fortification in a resource limited setting: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Neurodevelopmental outcome at 12 months corrected age in very low birth weight preterm infants receiving post discharge fortification and those receiving unfortified feeds after discharge.
研究概览
简要总结
This prospective randomized controlled trial aims to study the neurodevelopmental outcomes of very low birth weight preterm infants receiving post-discharge human milk fortification versus those receiving standard unfortified feeds.
Preterm VLBW infants often experience growth faltering and extrauterine growth restriction despite improved NICU survival rates. While human milk fortification during NICU stay is standard practice, most centers discontinue fortification at discharge, potentially compromising post-discharge growth and development.
The 18-month study will be conducted at KEM Hospital’s Level 3 NICU, enrolling 200 inborn preterm infants weighing less than 1500 grams at 37 weeks gestation or less. Participants will be randomized into two groups namely intervention group receiving continued HMF supplementation until reaching 1800 grams weight, and control group receiving standard calcium, iron, and vitamin D supplementation post-discharge.
Primary Outcome is to compare neurodevelopmental outcomes at 12 months corrected age using Bayley Scales of Infant and Toddler Development 4th edition between both groups.
Secondary Outcomes are to Assess weight gain, length and head circumference growth until 40 weeks postmenstrual age, feed intolerance incidence, mortality, anemia of prematurity, retinopathy of prematurity, and osteopenia of prematurity.
Methodology will be that Infants will receive bovine-based HMF at 1 gram per 25ml of human milk. Follow-up includes twice-weekly visits until 1.5kg, then bi-weekly until 1.8kg, with neuromotor assessments at term, 3, 6, 9, and 12 months corrected age.
Sample size of 174 infants calculated with 80% power, accounting for 15% loss to follow-up, totaling 200 participants. Analysis will follow intention-to-treat principle using appropriate statistical tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 7.00 Day(s) 至 99.00 Day(s)（—）
- 性别
- All
入选标准
- •Inborn neonates less than 37 completed weeks of gestation with birth weight less than 1500 grams who were on either mother’s milk or pasteurized donor human milk supplemented with bovine-derived HMF will be enrolled in the study within 48 hours before discharge.
排除标准
- •Preterm infants who do not tolerate HMF, infants with severe intraventricular hemorrhage (IVH), posthemorrhagic ventricular dilatation (PHVD), meningitis, surgical conditions, congenital anomalies and cyanotic congenital heart disease will be excluded.
结局指标
主要结局
Neurodevelopmental outcome at 12 months corrected age in very low birth weight preterm infants receiving post discharge fortification and those receiving unfortified feeds after discharge.
时间窗: 12 months corrected age
次要结局
- 1. Gain in weight, length and head circumference till 40 weeks postmenstrual age(40 weeks gestation, 3,6,9 and 12 months of age)
- Incidence of feed intolerance post discharge(Any time after discharge while infant is still on human milk fortification)
- Anemia of prematurity(within 3 months post discharge)
- Retinopathy of prematurity(3 weeks till 12 weeks)
- Mortality(Any time after discharge while infant is still on human milk fortification)
研究者
Anitha Haribalakrishna
Seth GS Medical College and King Edward Memorial Hospital