NCT02028156终止不适用
Evaluation of Feeding Intolerance in Formula-Fed Infants: A Non-Randomized, Single-Group, Multi-Center Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 3
- 主要终点
- Improvement in Fussiness
研究概览
简要总结
This is a non-randomized, single-group, multi-center, two phased study to evaluate formula intolerance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- — 至 60 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria for Stage 1:
- •Singleton full term birth with birth weight of > 2500g.
- •Infant between 0 and 60 days of age.
- •Discontinuation of medications that might affect gastrointestinal (GI) tolerance.
- •Infant is exclusively formula-fed a full-lactose, intact cow milk protein-based infant formula (CMF) for less than 7 days prior to enrollment.
- •Inclusion Criteria for Stage 2:
- •Infant was fed according to protocol in Stage 1 of the study.
- •Infant was identified as being fussy using the Intolerance Assessment Tool in Stage 1.
排除标准
- •Exclusion Criteria for Stage 1:
- •Chromosomal or major congenital anomalies.
- •Suspected or known metabolic or physical diseases affecting infant feeding and/or metabolism.
- •Hospitalization, other than for delivery, prior to enrollment.
- •Severe uncontrolled eczema, visible bloody stools or milk protein allergy prior to enrollment.
- •More than 1 substitution of an infant formula other than full-lactose, intact cow milk formula (CMF) since birth.
- •Use of a prokinetic drug within 7 days before enrollment.
- •Exclusion Criteria for Stage 2:
- •Infant's intolerance symptom was caused by another reason, for example known infection/illness, food allergy, or response to vaccination(s).
- •Infant has immunization(s) within 3 days of enrollment in Stage 2.
结局指标
主要结局
Improvement in Fussiness
时间窗: 0 to 15 days
Study phase 2; Parent completed questionnaire.
次要结局
- Constipation(0 to 4 weeks)
- Gassiness(0 to 4 weeks)
- Diarrhea(0 to 4 weeks)
- Spit-up(0 to 4 weeks)
研究者
研究点 (3)
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