NCT05551975尚未招募不适用
Growth and Tolerance of Preterm Infants Fed an Experimental Human Milk Fortifier
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 321
- 试验地点
- 28
- 主要终点
- Weight
研究概览
简要总结
This is a double-blind, randomized, multi-center, controlled, parallel study to evaluate the growth and tolerance of preterm infants fed human milk fortifier (HMF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birth weight between 700 g-1500 g.
- •≤ 32 weeks and 0 days GA at birth.
- •Participant has been classified as appropriate for GA (AGA).
- •Enteral feeding of human milk must be initiated by 21 days of life (birth date is day of life 0)
- •Mother agrees to provide human milk as the exclusive feeding during the study period; use of donor milk is permitted if fortified with study fortifier and use of mother's own milk (when available) is prioritized.
- •Parent(s) agrees to allow infant to receive both human milk and study HMF.
- •Singleton or twin births only.
- •Infant's parent(s) or a LAR has voluntarily signed and dated an ICF, approved by an IRB/IEC and provided HIPAA (or other applicable privacy regulation) authorization prior to any participation in the study.
排除标准
- •Enteral feeding of preterm infant formula or HMF for > 7 days.
- •Expected to be transferred to another facility within 30 days of randomization.
- •Serious congenital abnormalities or underlying disease that may affect growth and development.
- •5-minute APGAR ≤
- •Receiving systemic steroids at time of randomization.
- •Receiving probiotics at time of randomization.
- •Grade Ill or IV PVH/IVH.
- •Dependent on invasive ventilation at time of randomization.
- •Maternal incapacity.
- •Mother or infant is currently receiving treatment consistent with HIV therapy.
- •Documentation of maternal use of alcohol or marijuana during pregnancy that in the opinion of the physician is considered abuse.
- •Positive toxicology report for cocaine, opiates, or methamphetamine in mother or infant.
- •Infant has a history of major surgery (intra-thoracic or intra-abdominal procedures or other surgery requiring general anesthesia).
- •Asphyxia defined as progressive hypoxemia and hypercapnia with significant metabolic acidemia characterized by APGAR score <3 at 10 minutes, seizures within the first 12 hours of life, or a cord blood gas < 7.0 and seizures and/or severe tonic abnormalities in the first 12 hours of life.
- •Confirmed NEC (Bell's Stage II or III).
- •Confirmed current sepsis.
- •Infant has any other condition that, in the opinion of the investigator, precludes participation in the study.
- •Participation in another study that has not been approved as a concomitant study by AN.
- •Participant has an allergy or intolerance to any ingredient in study fortifier.
结局指标
主要结局
Weight
时间窗: Study Day 1 to Study Day 29 or Hospital Discharge if first
Weight gain per day
次要结局
- Head Circumference(Study Day 1 to Study Day 15 and Study Day 29)
- Feeding Intolerance(Study Day 1 to Study Day 29)
- Length(Study Day 1, 8, 15, 22, 29 and Hospital Discharge)
- Head Circumference (HC)(Study Day 1, 8, 15, 22, 29 and Hospital Discharge)
- Full Enteral Feeds(Study Day 1 to Study Day 29)
- Weight(Study Day 1 to Study Day 15)
- Stool Characteristics(Study Day 1 to Study Day 29)
研究者
研究点 (28)
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