NCT04389606已完成不适用
Follow-up Study of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants
ByHeart27 个研究点 分布在 1 个国家目标入组 311 人开始时间: 2020年5月12日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 311
- 试验地点
- 27
- 主要终点
- Weight Gain Velocity
研究概览
简要总结
The purpose of this two-month follow-up study is to continue to follow growth, safety, and other health outcomes of infants fed a new infant formula for term infants or comparator formula. A reference group of human milk-fed infants will also be followed. This study is designed in accordance with Good Clinical Practice guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Weeks 至 19 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who enrolled and completed the previous phase of the clinical trial: NCT04218929 "Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants"
排除标准
- •Subjects who did not enroll in the previous phase of the clinical trial: NCT04218929 "Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants"
研究组 & 干预措施
Comparator Formula (CF)
Active Comparator
Commercially available infant formula for term infants
干预措施: Study Formula (SF) (Other)
Study Formula (SF)
Experimental
New infant formula for term infants
干预措施: Study Formula (SF) (Other)
Study Formula (SF)
Experimental
New infant formula for term infants
干预措施: Comparator Formula (CF) (Other)
Comparator Formula (CF)
Active Comparator
Commercially available infant formula for term infants
干预措施: Comparator Formula (CF) (Other)
Human Milk Reference Group
No Intervention
Human milk
结局指标
主要结局
Weight Gain Velocity
时间窗: up to 24 weeks
G/D
次要结局
- Human milk composition (concentrations of proteins, lipids, carbohydrates, vitamins, and minerals(24 weeks)
- Weight Measures(20 weeks, 24 weeks)
- Weight for length Z-scores(20 weeks, 24 weeks)
- Parent report of infant stool frequency at each study visit(20 weeks, 24 weeks)
- Weight for age Z-scores(20 weeks, 24 weeks)
- Stool microbiome(24 weeks)
- Head Circumference Measures(20 weeks, 24 weeks)
- Length for age Z-scores(20 weeks, 24 weeks)
- Blood concentrations of amino acids (umol/L)(24 weeks)
- Length Measures(20 weeks, 24 weeks)
- Length Gain Velocity(20 weeks, 24 weeks)
- Head circumference for age Z-scores(20 weeks, 24 weeks)
- 72-hr record of formula intake at each study visit(20 weeks, 24 weeks)
- Blood concentrations of Interleukin-6 (pg/mL), Interleukin-10 (pg/mL), and tumor necrosis factor-alpha (pg/mL)(24 weeks)
- Medically-diagnosed adverse events collected throughout the study period(16-24 weeks)
- Parent rating of infant stool consistency at each study visit(20 weeks, 24 weeks)
- Parent report of infant disposition (fussiness, crying, gas, spit up, Infant Characteristics Questionnaire) at each study visit(20 weeks, 24 weeks)
- Stool metabolome(24 weeks)
研究者
研究点 (27)
Loading locations...
相似试验
已完成
1 期
Follow-up Study of Safety and Efficacy in Subjects Who Completed NEUROSTEM® Phase-I/IIa Clinical Trial.Alzheimer's DiseaseNCT03172117Medipost Co Ltd.36
Unknown
不适用
Clinical Extend Study to Evaluate Safety and Effectiveness of TnR Nasal Mesh for Correction of Nasal Septum on PatientsNasal ObstructionSeptal DeformityNCT04332575T&R Biofab Co., Ltd.20
招募中
不适用
Performance and Safety Assessment of SPRING THREAD® Elastic Tensor Thread in Patients with Mild to Moderate Facial Ptosis.PtosisPtosis, MildNCT057460781st SurgiConcept99
已完成
3 期
Follow up Study to Assess Long Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment StudiesObstetric Labour, PrematureNCT02292784GlaxoSmithKline98
已完成
不适用
Registry On Efficacy and Safety Of Rosuvastatin, and Atorvastatin and Simvastatin In HypercholesterolaemiaHypercholesterolaemiaNCT01352897AstraZeneca800