Clinical outcomes related to human milk fortification in very low birth weight preterm infants post discharge- a prospective observational study
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- gain in weight per day
研究概览
简要总结
Advancements in medical care over the past two decades has led to an improved survival of preterm infants globally. However, these preterm infants especially very low birth weight (VLBW) infants are at a higher risk of growth faltering during their neonatal intensive care unit (NICU) stay and infancy post discharge. Supplementation of expressed breast milk with a multi-nutrient bovine-based human milk fortifier (HMF) to meet these additional nutritional needs in preterm VLBW infants is currently the standard practice worldwide.Infants are discharged on full oral feeds along with iron, calcium and Vitamin D supplementation. These preterm infants are followed up in the preterm follow up centre and are at high risk of growth faltering due to early stoppage of HMF at discharge. . Hence, we decided to study the feasibility and effects of continuing HMF till these infants reach postnatal weight of 1800 gram or PMA of 40 weeks which was feasible only as post discharge fortification.Neonates meeting the inclusion criteria were allotted in one of the two groups two days prior to discharge: 1) intervention group where HMF was continued post discharge till infant reached 1.8 Kg 2) control group: HMF was stopped at discharge and infants were discharged on calcium, iron and vitamin D supplementation according to their weight.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 0.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •Inborn neonates ≤ 37 completed weeks of gestation with birth weight < 1.5 Kg who were on either mother’s own milk (MOM) or pasteurized donor human milk (PDHM) supplemented with bovine derived human milk fortifier (HMF) were enrolled in the study within 24 hours of life.
排除标准
- •Preterm infants who were not compliant with HMF, infants with severe intraventricular hemorrhage (IVH), post hemorrhagic ventricular dilatation (PHVD), meningitis, and poor neurological outcomes at discharge were excluded.
- •We also excluded surgical infants and those with congenital anomalies.
结局指标
主要结局
gain in weight per day
时间窗: 28 days
次要结局
- gain in length(28 days)
- gain in head circumference(28 days)
- incidence of NEC as per Bell’s stage ≥II(28 days)
- feed intolerance(28 days)
- late onset sepsis(28 days)
- mortality(28 days)
- anaemia of prematurity (AOP),(28 days)
- retinopathy of prematurity (ROP)(28 days)
- osteopenia of prematurity (OOP)(28 days)
- bronchopulmonary dysplasia (BPD)(28 days)
研究者
Anitha Haribalakrishna
Seth GS Medical College and KEM Hospital