A Randomised, Controlled, Double-blinded, Multi-country, Multi-centre Trial to Study Growth and Health Outcomes of a New Infant- and follow-on Formula for Healthy Term Infants.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 579
- 试验地点
- 2
- 主要终点
- Weight gain
研究概览
简要总结
To demonstrate growth equivalence of a Baby formula Test Product when compared to the Control product after 16 weeks. And to demonstrate better neurocognitive development at 52 weeks post-baseline in subjects receiving the Test Product, compared to subjects receiving the Control Product. Also, other anthropometric parameters will be investigated up to 52 weeks.
A Breastfed reference group, exclusively breastfed for at least 16 weeks, will also be included.
详细描述
The study will include infants to be randomised to receive the Test or Control product for 52, and infants whose parents have the intention to provide exclusively breastfeeding for at least 16 weeks after enrolment. Baseline assessments will be done at Visit 1/enrolment visits.
Subjects will return for clinic visits at 2 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6) 26 (Visit 7), 39 (Visit 8), and 52 (Visit 9) weeks post-baseline. During these clinic visits the investigator will perform anthropometric measurements, interview parent(s) about their infant's product intake/breastfeeding, occurrence of (serious) adverse events, medication/nutritional supplement use, details of infections and antibiotic/antiviral usage (if applicable).
At selected visits the following will be assessed a) stool characteristics (V2, 4, 6, 7,8, 9)); b) type of weaning food introduction (as of V6); c) neurocognitive development (V9); d) a three-day 24 hour food recall for dietary intake; e) stool samples at (V1, 6, 9); and f) blood sample (V6).
Also, a follow-up phone call is planned 2 weeks after the last visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 0 Days 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, singleton, term born infants (gestational age ≥ 37 weeks + 0 days and ≤ 41 weeks + 6 days).
- •Infants aged ≤ 14 days at enrolment.
- •Weight at birth within 10th to 90th percentile per gestational age and sex, according to Intergrowth Standards
- •For formula feeding groups: Infants fully formula fed at the time of enrolment.
- •For breastfed reference group: Infants exclusively breastfed at the time of enrolment and parent(s) intend to exclusively breastfeed the infant at least until 16 weeks after Visit
- •Written informed consent (IC) from parent(s) and/or legally acceptable representative(s) aged ≥18 years at enrolment.
排除标准
- •. Infants who require a special diet other than IF with intact cow's milk protein.
- •Infants known or suspected to have cow's milk, fish, and/or soy allergy and/or lactose intolerance.
- •Infants with current or previous illnesses/conditions and/or known or suspected congenital diseases or malformations which could interfere with the study outcomes, as per investigator's clinical judgement.
- •Infants whose mother is known to suffer from an illness or condition which could interfere with the study outcomes, as per investigator's clinical judgement.
- •Infants with previous, current, or intended participation in any concomitant clinical study involving investigational or marketed products.
- •Investigator's uncertainty about the willingness or ability of parents or legally acceptable representative(s) to comply with the protocol requirements.
结局指标
主要结局
Weight gain
时间窗: Baseline to 16 weeks post-baseline
To demonstrate equivalence in mean weight gain per day from baseline to 16 weeks post-baseline in subjects receiving the Test product, compared to subjects receiving the Control product
次要结局
- Neurocognitive Development(52 weeks post baseline)