NCT04541095招募中不适用
A Randomized, Multicenter, Controlled Clinical Trial to Assess Weight Gain of Preterm Infants Fed a New Infant Milk Formula Containing High Amounts of Beta-palmitate Versus a Standard Infant Milk Formula Containing Low Amounts of Beta-palmitate
Ospedali Riuniti Ancona4 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年1月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Weight gain
研究概览
简要总结
The aim of this study is to assess weight gain of preterm infants (gestational age lower than 32 weeks) fed infant milk formula with about 60% beta-palmitate (EX_IMF) vs infant milk formula with similar macronutrient, mineral and fatty acid composition but lower amounts of beta-palmitate (ST_IMF). Own mother milk (OMM) fed infants will serve as reference group.
详细描述
A large number of low birth weight infants during their hospital stay experience poor growth and this has been linked to reduced neurodevelopment scores.
Several enriched infant milk formulas are available for preterm infants who cannot be fed human milk. The use of infant milk formulas (IMF) enriched with triglycerides similar to human milk lipids have shown to be associated with better fatty acid and mineral intestinal absorption.
In this multicenter, randomized, controlled clinical trial, preterm infants (gestational age lower than 32 weeks), who can not be fed human milk, will be randomized to receive IMF with high or low amounts of beta-palmitate (about 60% vs 10%, respectively). A non-randomized own human milk-fed group will be included as a reference. Patients will be on the study diet as soon as possible after birth and till 36 weeks of gestation. Neurodevelopment follow-up will be performed at 24 months corrected 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
- 24 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •gestational age between 24 and 32 weeks of gestation at enrollment,
- •birth weight greater than 750 grams,
- •singleton or twin birth (no triplet or higher),
- •fraction of inspired oxygen lower than 0.60 at enrollment,
- •feasible enteral feeding,
- •cardiovascular stable condition,
- •informed consent form signed by at least one parent or legal guardian.
排除标准
- •congenital malformations, genetic, metabolic and endocrine disorders,
- •suspicious infection at enrollment,
- •intrauterine growth restriction (<10th centile) at enrollment,
- •maternal diabetes requiring insulin therapy,
- •neonatal asphyxia.
结局指标
主要结局
Weight gain
时间窗: From birth to 36 weeks of gestational age or until discharge if this occurred before.
Body weight will be daily measured by using an electronic balance (g/kg).
次要结局
- Stooling pattern(At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.)
- Stool biochemical composition - Total fatty acids(At 32 and then at 36 weeks of gestational age or until discharge if this occurred before.)
- Parenteral nutrition intakes - amino acids(From birth to 36 weeks of gestational age or until discharge if this occurred before.)
- Stool biochemical composition - Palmitic acid(At 32 and then at 36 weeks of gestational age or until discharge if this occurred before.)
- Total body length(At 32, 34 and 36 weeks of gestational age or until discharge if this occurred before and then at 24 months of corrected age.)
- Head circumference(At 32, 34 and 36 weeks of gestational age or until discharge if this occurred before and then at 24 months of corrected age.)
- Blood biochemistry - Triglycerides(At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.)
- Blood biochemistry - Urea(At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.)
- Crying(For 1 consecutive day at 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.)
- Parenteral nutrition intakes - lipids(From birth to 36 weeks of gestational age or until discharge if this occurred before.)
- Stool biochemical composition - Magnesium(At 32 and then at 36 weeks of gestational age or until discharge if this occurred before.)
- Physical activity(For 1 consecutive day at 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before..)
- Stool biochemical composition - Phosphorus(At 32 and then at 36 weeks of gestational age or until discharge if this occurred before.)
- Stool biochemical composition - Hydroxylic acids(At 32 and then at 36 weeks of gestational age or until discharge if this occurred before.)
- Human milk intakes(From birth to 36 weeks of gestational age or until discharge if this occurred before.)
- Blood biochemistry - Phospholipids(At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.)
- Total body water(At 36 weeks of gestational age or until discharge if this occurred before.)
- In-hospital death(Daily from birth to 36 weeks of gestational age or until discharge if this occurred before.)
- Parathyroid hormone(At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.)
- Parenteral nutrition intakes - cumulative volume(From birth to 36 weeks of gestational age or until discharge if this occurred before.)
- Blood biochemistry - Cholesterol(At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.)
- Blood biochemistry - Calcium(At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.)
- Stool bifidobacteria(At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.)
- Gastrointestinal problems(Daily from birth to 36 weeks of gestational age or until discharge if this occurred before.)
- Stool biochemical composition - Calcium(At 32 and then at 36 weeks of gestational age or until discharge if this occurred before.)
- Infant formula intakes(From birth to 36 weeks of gestational age or until discharge if this occurred before.)
- Parenteral nutrition intakes - glucose(From birth to 36 weeks of gestational age or until discharge if this occurred before.)
- Parenteral nutrition duration(From birth to 36 weeks of gestational age or until discharge if this occurred before.)
- Body weight(At 32, 34 and 36 weeks of gestational age or until discharge if this occurred before and then at 24 months of corrected age..)
- Blood biochemistry - Fatty acids(At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.)
- Blood biochemistry - Bilirubin(At 7 and 42 days of postnatal age.)
- Blood biochemistry - Electrolytes(At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.)
- Neurodevelopmental assessment(At 24 months of corrected age.)
- Liver function tests(At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.)
- Urinary dicarboxylic acid excretion(At 32 and then at 36 weeks of gestational age or until discharge if this occurred before.)
- Blood biochemistry - Glycaemia(At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.)
- Blood biochemistry - Phosphorus(At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.)
- Complications of prematurity(Daily from birth to 36 weeks of gestational age or until discharge if this occurred before.)
- Urinary calcium(At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.)
- Urinary urea(At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.)
- Urinary phosphorus(At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.)
- Metabolic complications(Daily from birth to 36 weeks of gestational age or until discharge if this occurred before.)
研究者
Virgilio Paolo Carnielli
The Director of Neonatology
Ospedali Riuniti Ancona
研究点 (4)
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