Growth and Tolerance in New Born Fed Formula Supplemented With Alpha-Lactalbumin and Containing a Symbiotic
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sodilac
- 入组人数
- 97
- 试验地点
- 8
- 主要终点
- Growth Parameters
研究概览
简要总结
The purpose of the study is to assess growth and tolerance in new born and infant fed an experimental infant formula with reduced total protein concentration, enriched in alpha-lactalbumin and containing a symbiotic.
详细描述
This prospective, randomized, double blind, controlled study evaluated the safety and effect on growth and tolerance to an infant formula supplemented with alpha-lactalbumin and containing a symbiotic, in term infants.
Term infants with a gestational age ranging from 37 to 42 weeks and whose parents chose formula feeding were enrolled during their first eight days of life.
Both parents provided informed written consent. Infants were randomly assigned to receive either the new test formula or a control, a regular formula adapted for term infants (Modilac®1). The control formula is formulated to meet the nutritional needs of infants.
For each neonates, neonatal parameters were collected.
5 visits took place : V1 (inclusion), V2 (randomization), V3 (1 month), V4 (3 months) and V5 (6 months). During each visit, the investigator filled in observational book the anthropometric parameters (weight, height, head circumference, BMI) and pieces of information collected 3 days before by the parents (gastrointestinal tolerance parameters, daily infant behaviour and milk consumption). Global parents' contentment was evaluated as well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 8 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Term health newborn infant with gestational age ranging from 37 to 42 weeks
- •Eutrophic
- •Non breastfed children
- •Apgar score > 5 to 7 minutes
排除标准
- •Infant presenting a metabolic, nervous, digestive or organic disease able to interfere with study
- •Evidence of protein cow milk allergy
- •Infant presenting lactose intolerance
- •Newborn whose parents did not provide informed consent
- •Newborn currently participating in another trial
结局指标
主要结局
Growth Parameters
时间窗: 1, 3 and 6 months
次要结局
- Sensitization or allergy(1, 3 and 6 months)
- Atopic diseases (eczema atopic, asthma, allergic rhinitis)(1, 3 and 6 months)
- Describe the intestinal flora according to the nutrition group(1 and 6 months)
- Clinical Tolerance(1 and 6 months)