Early Life Protein-enriched Human Milk Diets to Increase Lean Body Mass Accretion and Diversity of the Gut Microbiome in Extremely Preterm Infants: a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Fat-free Mass(FFM)-For-age Z-score
研究概览
简要总结
The central hypothesis of this clinical trial is that, in extremely preterm infants, protein-enriched human milk diets compared to usual human milk diets during the first 2 weeks after birth increase fat-free mass (FFM)-for-age Z scores and promote maturation of the gut microbiome at term corrected age.
详细描述
Masked randomized clinical trial in which extremely preterm infants fed human milk will be randomly assigned to receive either a protein-enriched diet (intervention group) or a usual diet (control group) within the first 96 hours 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
Caregivers and primary outcome evaluators will be masked. Nutrition room staff not involved in patient care will be responsible for determining participant allocation to one of the supplementation groups by opening sequentially numbered sealed envelopes, dispensing feeding syringes with the allocated human milk diet (protein-enriched or usual), and masking caregivers administering the assigned dietary intervention.
入排标准
- 年龄范围
- 1 Day 至 4 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 < 96 hours
排除标准
- •Congenital malformations
- •Chromosomal anomalies
- •Terminal illness needing to limit or withhold support
研究组 & 干预措施
Usual human milk diet
Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth.
干预措施: Usual human milk diet (Procedure)
Protein-enriched human milk diet
Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth.
干预措施: Protein-enriched human milk diet (Procedure)
结局指标
主要结局
Fat-free Mass(FFM)-For-age Z-score
时间窗: 36 weeks or hospital discharge, up to 120 days following birth, whichever is longer
Estimated by air displacement plethysmography. FFM measurements were converted into Z-scores using updated, sex-specific reference curves of body composition in preterm infants (Norris et al, 2019). A Z-score of 0 represents the population mean. Z-score values closer to 0 represent a better outcome. No relevant thresholds have been defined.
次要结局
- Body Fat(BF)-For-age Z-score(36 weeks or hospital discharge, up to 120 days following birth, whichever is longer)
- Number of Participants With Diagnosis of Necrotizing Enterocolitis(From birth up to 120 days following birth)
- Number of Days Alive and Receiving Full Enteral Feeding(Birth to 28 days)
- Serum BUN(Birth to 28 days)
- Number of Episodes of Feeding Intolerance(Birth to 28 days)
- Duration of Hospital Stay in Days(Birth to 120 days or discharge, whichever occurs first)
- Anthropometric Measurements(Birth to 36 weeks postmenstrual age or hospital discharge (whichever occurred first))
- Growth Rate(Birth to 36 weeks postmenstrual age or hospital discharge (whichever occurred first))
- Number of Participants With Postnatal Growth Failure(36 weeks or hospital discharge (whichever occurred first))
- Number of Participants With Diagnosis of Intestinal Perforation(From birth up to 120 days following birth)
- Fat Mass(FM)-For-age Z-score(36 weeks or hospital discharge, up to 120 days following birth, whichever is longer)
- Death(Birth to 120 days)
- Culture-proven Sepsis(Birth to 120 days)
研究者
Ariel A. Salas
Principal Investigator
University of Alabama at Birmingham