NCT04360967撤回不适用
Neurodevelopment, Growth, and Metabolic Syndrome Biomarkers in Term Small-for-gestational-age Infants Fed Standard or Nutrient-enriched Formula
Société des Produits Nestlé (SPN)0 个研究点开始时间: 2017年3月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Evaluation of neurodevelopment
研究概览
简要总结
The purpose of this study is to determine whether term SGA infants who are fed a nutrient-enriched pre-term formula will have a higher cognitive score, a more appropriate length-for-age Z-score (leading to a lower prevalence of Stunting) but higher blood pressure at 2 years of age compared to term SGA infants who are fed on a regular starter formula.
详细描述
This is multi-sites, interventional, double-blinded, randomized, 2-arm parallel-group clinical trial. Two HM fed groups will be included as comparator group.
The primary objectives are:
- To evaluate neurodevelopment at 2 years of age in term small-for-gestational age (SGA) infants fed standard formula or nutrient-enriched formula from 1 to 6 months of age and compare to each human milk (HM)-fed group.
- To evaluate length-for-age Z-score at 2 years of age in term SGA infants fed standard formula or nutrient-enriched formula from 1 to 6 months of age and compare to each HM-fed group.
- To evaluate systolic blood pressure at 2 years of age in term SGA infants fed standard formula or nutrient-enriched formula from 1 to 6 months of age and compare to each HM-fed group.
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
- 1 Day 至 44 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Having obtained his/her parents' (or his/her legally accepted representative's LAR's]) written informed consent and having evidence of a personally signed and dated informed consent document indicating that the infant's parents/LAR have been informed of pertinent aspects of the study.
- •For infants in formula fed groups only: infants who require formula feeding due to lactation failure after minimum 2 rounds of breastfeeding counselling.
- •Birth Weight < 10th percentile at term using the 2013 INTERGROWTH-21st Growth Charts for girls and boys.
- •Full term birth (gestational age ≥ 37 weeks and ≤ 41 weeks + 6 days), with gestational age estimated using fetal anthropometry by ultrasonography in early 1st trimester of pregnancy or calculated using the first day of the last menstrual period + 40 weeks if fetal anthropometry data for term calculation is not available or was collected after the 1st trimester.
- •Age <45 days at time of enrollment
- •For infants in the HM-fed AGA comparator group only: born to mothers with pre-pregnancy body mass index (BMI) ≥ 18.5 and <25kg/m2
排除标准
- •mothers with Type-1 Diabetes
- •mothers who smoked >10 cigarettes per day during pregnancy.
- •mothers who used Illicit drugs (e.g. marijuana, cocaine, amphetamines, or heroin) or alcohol (>3 alcoholic beverages per week) during pregnancy
- •Suspected or documented systemic or congenital infections (e.g Human Immunodeficiency virus, cytomegalovirus)
- •Genetic or any other type of congenital malformations, metabolic, cardiovascular, gastrointestinal, pancreatic or hepatic diseases or medical conditions that could compromise growth and/or food intake.
- •Fit to be discharged from neonatal intensive care unit (NICU) in > 5 consecutive days with the exception of infants in the NICU due to jaundice only.
- •Known or suspected intolerance/ allergy to milk protein or any ingredient in the study formulas
- •For infants in the HM-fed groups only: infants who are consuming fortified human milk or formula.
- •Participation in any other interventional clinical trial during the 14 days prior to enrollment.
- •Infants or infant's family who in the investigator's judgement cannot be expected to comply with the protocol or study procedures.
结局指标
主要结局
Evaluation of neurodevelopment
时间窗: at the baseline (2 years of age)
Assessed using Bayley Scales of Infant and Toddler Development® - Third Edition - (To compare with the standard Bayley scores).
Evaluation of length-for-age Z-score
时间窗: Evaluated once at 2 years of age
Using the WHO growth chart
Systolic Blood pressure
时间窗: at baseline (2 years of age)
Systolic and diastolic blood pressure measurement from 1 to 6 months of age
次要结局
- Neurodevelopment(At last visit ( 5 years of age))
- Safety (Adverse Event reporting)(From 1 to 6 months of age & 6 months to 5 years of age.)
- Evaluation of urinary markers of bone metabolism(At visit 4 (6 months))
- Evaluation of insulin sensitivity(at last visit ( 5 years of age).)
- Growth (Length)(At 2 years of age)
- Growth (Head circumference)(At 2 years of age)
- Growth (Weight)(At 2 years of age)
- Body fat mass (%)(evaluated until 5 years of age.)
- Growth (Z-Scores)(At 2 years of age)
- Evaluation of serum markers of bone metabolism(At visit 4 (6 months))
研究者
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