MaxiMoM: Individualized Fortification of Human Milk for Infants Born ≤ 1250 g; a Three Arm Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 615
- 试验地点
- 40
- 主要终点
- Cognitive Composite Score
研究概览
简要总结
Very low birth weight infants have increased nutritional needs. Extra nutrients are added to their human milk feeds to help improve their nutritional status, growth and neurodevelopment. Standard fortification of human milk is routine in most neonatal units in North America, but despite the added nutrients, infants are often discharged from hospitals with poor growth, and their neurodevelopment remains suboptimal. Two individualized fortification methods, target and BUN adjustable, have been proposed to improve the nutrient supply to infants. However, there is currently insufficient evidence to support the implementation of individualized fortification or one method over the other. Therefore, this study will randomly assign very low birth weight infants to receive feeds fortified according to standard, target or BUN adjustable fortification methods until the end of the feeding intervention. Feedings will be prepared in milk preparation rooms to ensure caregivers and outcomes assessor remain blinded to feeding allocation. Growth, morbidities, and nutrient intakes will be determined throughout hospitalization and skinfolds assessed at 36 weeks. At 4 months CA, growth and body composition will be determined by air displacement plethysmography on a subset of infants. Neurodevelopment will be assessed using the Bayley Scales of Infant and Toddler Development, at 18-24 months CA.
详细描述
The end of the feeding intervention is defined as: the infant is 36+0 weeks CA, is discharged home, or receives two oral feeds daily for three consecutive days without top-up. The exception to the 36+0 weeks intervention end-date is in the situation where an infant remains hospitalized but has not completed at least four weeks of the feeding intervention (i.e. 4 weeks following Study Day 1).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 21 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≤1250 g birth weight or Gestational Age <30+0 weeks and <1500 g birth weight.
- •Parental/guardian consent to participate.
- •Consent for the use of pasteurized donor milk if mother's milk is not available.
排除标准
- •Infant received fortifier or formula before Study Day
- •Study Day 1 anticipated to occur after postnatal day
- •Infants with congenital or chromosomal anomalies or brain injury that may affect growth or neurodevelopment.
- •Enrollment in any other clinical study affecting nutritional management during the feeding intervention.
- •Reasonable potential that the infant will be transferred to a NICU where the study protocol will not be continued before they have completed at least 4 weeks of the feeding intervention.
研究组 & 干预措施
Standard fortification
干预措施: Standard fortification (Other)
Target fortification
干预措施: Target fortification (Other)
BUN adjustable fortification
干预措施: BUN adjustable fortification (Other)
结局指标
主要结局
Cognitive Composite Score
时间窗: 18-24 months corrected age
Bayley Scales of Infant and Toddler Development
次要结局
- Language Composite Score(18-24 months CA)
- Motor Composite Score(18-24 months CA)
- Weight Gain during the intervention(Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first)
- Length gain during the intervention(Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first)
- Head circumference gain during the intervention(Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first)
- Body composition at the end of the intervention(36 weeks corrected age)
- Serious Morbidity(Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first)
- Health Economics(Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first)
- Weight at follow-up(4 months corrected age)
- Length at follow-up(4 months corrected age)
- Head Circumference at follow-up(4 months corrected age)
- Body composition at follow-up (approximated)(4 months corrected age)
- Body composition at follow-up (direct measurement)(4 months corrected age)
研究者
Deborah O'Connor
Senior Associate Scientist
The Hospital for Sick Children