Improving Lung Health in Premature Babies Through Early Nutrition: The More & Early Nutritional Delivery for Bronchopulmonary Dysplasia (MEND-BPD) Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Severity of respiratory morbidity
研究概览
简要总结
This Phase II, parallel-group, masked, randomized clinical trial aims to evaluate whether a DHA/ARA-enriched, fortified human milk diet administered during the first 14 days of life reduces respiratory morbidity and improves lung function in extremely preterm (EPT) infants (born at ≤28 weeks gestation).
详细描述
This is a masked randomized clinical trial in which extremely preterm infants fed human milk will be randomly assigned to receive either a docosahexaenoic acid/arachidonic acid (DHA/ARA)-enriched, fortified human milk diet (intervention group) or a standard fortified human milk diet (control group) during the first 14 days after birth.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
To maintain trial integrity, nutrition room staff that are independent of clinical care will prepare the feeding syringes without DHA/ARA labels to ensure clinicians, parents, and evaluators remain masked.
入排标准
- 年龄范围
- 1 Day 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age ≤ 28 weeks of gestation
- •Postnatal age < 72 hours
排除标准
- •Congenital malformations
- •Chromosomal anomalies
- •Terminal illness needing to limit or withhold support
研究组 & 干预措施
Standard-energy Group
The control group receives a standard fortified human milk (maternal or donor) diet for the first 14 days.
干预措施: Standard-energy group (Other)
High-energy Group
The intervention group receives a standard fortified human milk (maternal or donor) diet plus the DHA/ARA supplement for the first 14 days. Infants in this group will be secondarily assigned to either a low-dose (60/120 mg/kg/day) or high-dose (120/240 mg/kg/day) DHA/ARA supplement.
干预措施: High-energy group (Dietary Supplement)
结局指标
主要结局
Severity of respiratory morbidity
时间窗: 0 - 120 days
A scoring system that defines severity of respiratory morbidity (bronchopulmonary dysplasia severity) based on the amount of ventilatory support and the need for supplemental oxygen at 36 weeks postmenstrual age using the Jensen criteria, an ordinal scale ranging from 0 (no respiratory support) to 1 (mild BPD: low-flow nasal cannula ≤2 L/min requirement); 2 (moderate BPD: non-invasive respiratory support, including high-flow nasal cannula \>2 L/min, CPAP, or non-invasive positive pressure ventilation); 3 (severe BPD - invasive mechanical ventilation); or 4 (death), with progressively higher scores indicating increasing respiratory morbidity and worse clinical outcomes.
Non-invasive impulse oscillometry measurements of pulmonary mechanics
时间窗: 40 - 120 days
Using the N-100 Neo Oscillometry device, we will determine the area under the reactance curve (AX)
次要结局
- Bronchopulmonary dysplasia(40 - 120 days)
研究者
Ariel A. Salas
Associate Professor
University of Alabama at Birmingham