A Multicenter Randomized Clinical Trial Comparing Two Human Milk Volumes to Optimize Growth and Gut Health in Infants Born Very Preterm
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 486
- 试验地点
- 8
- 主要终点
- Fat-free Mass (FFM)-For-age-Z-score
研究概览
简要总结
The goal of this multi-center randomized, parallel group trial is to determine the effect of human milk diets ranging between 180 and 200 mL/kg/day on the body composition outcomes of moderately preterm infants born between 27 and 31 weeks of gestation.
详细描述
Participants will be randomized once they reach 120 mL/kg/day. Clinicians will be able to increase feeds each day as they see fit, until the patient reaches the target goal of 140-160 mL/kg/day or 180-200 mL/kg/day. They will then maintain this volume until 34 weeks postmenstrual age. Researchers will compare these two targets to see if higher feeding volumes prevent faltering growth without causing adverse metabolic outcomes.
Participants will:
- Have a feeding volume of 180-200 mL/kg/day or a volume of 140-160 mL/kg/day until 34 weeks corrected age
- Have four body composition assessments with a bioelectrical impedance analyzer throughout study period
- Have four stool samples collected throughout study period
- Have four maternal breastmilk samples collected and analyzed throughout the study period
- Have one blood sample collected at 36 weeks corrected age
- Have the option to participate in a follow-up survey completed by parents at 2-3 years of age
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Hours 至 4 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age between 27 0/7 and 31 6/7 weeks
- •Birthweight of 1500 grams or less
- •Human milk feeding during the first 14 days after birth
- •Full enteral feeding (120mL/kg/day or more) within the first 14 days after birth
排除标准
- •Necrotizing enterocolitis stage 2 or greater
- •Spontaneous intestinal perforation
- •Major congenital/chromosomal anomalies
- •Terminal illness requiring limited or withheld support
- •Intention to restrict fluid intake after the first 14 postnatal days due to the presence of a symptomatic patent ductus arteriosus (PDA)
- •Any formula feeding within the first 14 days after birth
结局指标
主要结局
Fat-free Mass (FFM)-For-age-Z-score
时间窗: 36 weeks post menstrual age or hospital discharge, up to 120 days following birth, whichever is longer
Estimated by bioelectric impedance analysis. FFM measurements will be converted into Z-scores using updated, sex specific reference curves of body composition in preterm infants
次要结局
- Body fat percentage(Birth to 36 weeks postmenstrual age)
- Anthropometric Measurements(Birth to 36 weeks postmenstrual age)
- Number of Participants with Postnatal Faltering Growth(36 weeks or hospital discharge (whichever occurs first))
- Death(Birth to 120 days)
- Culture-proven Sepsis(Birth to 120 days)
- Post discharge growth outcomes(22-26 months corrected age)
- Body Fat (BF)-For age Z-score(36 weeks post menstrual age or hospital discharge, up to 120 days following birth, whichever is longer)
- Number of Days Alive and Receiving Full Enteral Feeding(Birth to 28 days)
- Duration of Hospital Stay in Days(Birth to 120 days or discharge, whichever occurs first)
- Fat Mass (FM)- For age Z-score(36 weeks or hospital discharge, up to 120 days following birth, whichever is longer)
- Duration of parenteral nutrition(Birth to 28 days of life)
- Bronchopulmonary Dysplasia(36 weeks post menstrual age or hospital discharge, up to 120 days following birth, whichever is longer)
- Growth Rate(Birth to 36 weeks postmenstrual age or hospital discharge (whichever occurs first).)
- Number of Participants diagnosed with Necrotizing Enterocolitis(From birth up to 120 days following birth)
- Number of Participants with Diagnosis of Intestinal Perforation(From birth up to 120 days following birth)
研究者
Ariel A. Salas
Associate Professor
University of Alabama at Birmingham