Effect of two different thresholds to initiate nutritional interventions for postnatal growth faltering on neurodevelopmental disability in very preterm infants: a multicenter randomized controlled trial.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 654
- 试验地点
- 3
- 主要终点
- Major neurodevelopmental disability at 18-20 months corrected age, defined as one or more of the following:
研究概览
简要总结
This randomized, parallel-arm trial aims to compare the effect of two weight loss thresholds to initiate interventions for postnatal growth faltering (PGF), on major neurodevelopmental disability at 18-20 months corrected age in very preterm infants born at a gestational age of <33 completed weeks. Enrolment in this RCT is expected to happen at three centres.
Research question: In very preterm infants born at a gestational age of <33 completed weeks (Population), is an aggressive strategy of initiation of nutritional interventions when the postnatal weight z-score drops >1 z-score below the birth z-score (Intervention), compared with a conservative approach of only intervening if the weight z-score drops >1.5 z-score below the birth z-score (Comparator) associated with a lower incidence of major neurodevelopmental disability (Outcome) at 18-20 months corrected age (Time)?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 10.00 Day(s) 至 77.00 Day(s)（—）
- 性别
- All
入选标准
- •Birth gestational age <33 completed weeks.
- •Postnatal weight >1 z score below the birth z score between 10 days of age and 36 weeks postmenstrual age.
排除标准
- •Major congenital anomalies or genetic conditions.
- •Infants on comfort care who are not expected to survive.
- •NICU admission after 48 hours of age.
结局指标
主要结局
Major neurodevelopmental disability at 18-20 months corrected age, defined as one or more of the following:
时间窗: 18 to 20 months corrected age.
1. Bayley-4 standard score less than 70 in Cognitive or Motor or Language domain.
时间窗: 18 to 20 months corrected age.
2. Cerebral palsy GMFCS more than class I.
时间窗: 18 to 20 months corrected age.
3. Hearing loss requiring hearing aid.
时间窗: 18 to 20 months corrected age.
4. Blindness (vision of less than 3/60 in the better eye)
时间窗: 18 to 20 months corrected age.
次要结局
- Death before discharge(First hospital discharge)
- Neonatal death(28 days)
- Death(18-20 months)
- Retinopathy of prematurity requiring treatment(18 months)
- Necrotizing enterocolitis Stage 2 or higher(First hospital discharge)
- Bronchopulmonary dysplasia(First hospital discharge)
- Microcephaly(18-20 months)
- Underweight(18-20 months)
- Overweight(18-20 months)
- Hypertension(18-20 months)
研究者
Nishad Plakkal
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)