Use of a Liquid Supplement Containing 2 Human Milk Oligosaccharides (HMOs) in Preterm Infants: a Double-blind, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 14
- 主要终点
- Feeding tolerance
研究概览
简要总结
This is a prospective, randomized, double-blind, placebo-controlled trial in preterm infants conducted at least 4 centers in France, consisting of 2 parallel groups. The experimental group will receive a neonatal supplement containing 2 specific HMOs. The control group will receive a placebo neonatal supplement that does not contain any HMOs, but matched to the experimental product in energy content.
This study will include a total of approximately 86 male and female preterm infants born between 27 and 32 weeks' gestational age with birth weight ≤1700 g, who are younger than 7 days of age.
The primary objective of the study is to demonstrate the safety and tolerance of HMOs in preterm infants by monitoring weight gain rates in both of the two randomized groups.
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)
入排标准
- 年龄范围
- — 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infant's birth weight ≤1700 g.
- •Infant's gestational age ≥ 27 weeks + 0 days and ≤ 32 weeks + 6 days.
- •Infant is clinically stable
- •Infants are eligible to start HMOs / placebo as soon as possible after birth, but still within the first 7 days of life.
- •Written informed consent has been obtained from the parents/legally acceptable representative (LAR).
排除标准
- •Parents not willing / not able to comply with the requirements of study protocol.
- •Infants receiving ongoing prophylactic antifungal therapies.
- •Infants experiencing early onset sepsis.
- •Major congenital or chromosomal abnormality known to affect growth.
- •Liver failure.
- •Severe intrauterine growth restriction (IUGR) as defined by having birth weight less than 2nd percentile on the Fenton growth chart.
- •Peri-/intra-ventricular haemorrhage (grade 3-4 in Papille classification) .
- •Infant in critical condition needing intubation or inotropic agents for treatment.
- •Infant requiring prolonged (more than 3 doses) of steroid treatment.
- •Infants' participation in another interventional clinical trial that would have significant impact on current study's results.
- •Infants who have already achieved Full Enteral Feeding (FEF) prior to enrolment, using the definition accepted by neonatal unit as per standard practice (150 mL/kg/day).
结局指标
主要结局
Feeding tolerance
时间窗: Change from Full Enteral Feeding (FEF) Day 1 (start of FEF defined as achieving 150ml/day/kg of enteral feeding and discontinuation of parenteral feeding) and FEF Day 21 (approximately 5 weeks after enrollment)
The primary objective is to demonstrate non-inferiority in feeding tolerance (defined as number of days to reach full enteral feeding) of preterm infants receiving a liquid supplement composed of 2 HMOs compared to those receiving the placebo.
次要结局
- Tolerance to feeding regimen(Change from enrolment (baseline) (if feasible) through study completion, average of 4 months)
- Length(Change from enrolment (baseline) (if feasible) through study completion, average of 4 months)
- Head circumference(Change from enrolment (baseline) (if feasible) through study completion, average of 4 months)
- Breast milk composition such as energy, carbohydrate, proteins and fats using mid-infrared transmission methods(Change from enrolment (baseline) (if feasible) until FEF Day 21, average of 5 weeks)
- Standard Adverse Event reporting for safety assessment(Change from enrolment (baseline) (if feasible) through study completion, average of 4 months)
- Fecal microbiota composition and diversity(Change from enrolment (baseline) through two-months corrected age visit)
- Fecal metabolic profile(Change from enrolment (baseline) through two-months corrected age visit)
- Markers for gut health, gut maturation and immune status(Change from enrolment (baseline) (if feasible) until FEF Day 21)
- Weight gain(Change from enrolment (baseline) (if feasible) through study completion, average of 4 months)
- Assessment of infant illnesses and infections(Change from enrolment (baseline) (if feasible) through study completion, average of 4 months)
- Physical signs of gastrointestinal tolerance(Change from enrolment (baseline) (if feasible) through study completion, average of 4 months)
- Early life development outcomes(At 12 Months Corrected age Visit, 18 Months Corrected age Visit, and 24 Months Corrected age Visit)
- Cognitive development outcomes(24 Months Corrected age Visit)