Growth and Feeding Tolerance of Infants Consuming a Formula Supplemented With Human Milk Oligosaccharides (HMOs): An Uncontrolled, Open-label, Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 207
- 试验地点
- 11
- 主要终点
- World Health Organization (WHO) based weight-for-age z-scores
研究概览
简要总结
Human milk oligosaccharides (HMOs) represent the third largest solid component of breast milk. Technology advancements made it possible to supplement infant formulas with HMOs (2'FL, LNnT). Two published RCTs have demonstrated that infant formulas supplemented with 2'FL or 2'FL+LNnT are safe, well-tolerated, support normal grow, and may support healthy GI function and confer immune benefits. The performance of HMOs-supplemented formulas assessed in a real-world setting is complementary to previously conducted RCTs conducted in highly controlled clinical settings. Main objectives will be to monitor the safety & tolerance of HMOs-supplemented formulas in larger and diverse infant populations; to assess the performance of HMOs-supplemented formulas in mixed-fed infants, a population that was not studied in previous RCTs but likely represents a relatively common feeding regimen. Finally, considering the potential health/immune benefits of HMOs, it is also important explore the incidences of illnesses (i.e., respiratory illnesses, GI illnesses, and fever) associated with consuming HMOs-supplemented formulas and compare with breastfed infants data.
详细描述
Objectives:
The main objective of this study is to document the growth and feeding tolerance of healthy term infants consuming an infant formula supplemented with HMOs for 8 weeks (56 days), in a real-world setting.
Main endpoints:
- Growth documented via monitoring the anthropometric parameters including weight, length, head circumference, BMI and their corresponding z-scores (i.e., z-scores for weight-for-age, length-for-age, weight-for-length, head circumference-for-age, and BMI-for-age) calculated using the 2006 WHO Growth Standards
- Feeding tolerance assessed via monitoring parent-reported overall GI symptom burden measured by the Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score (13-item summary score)
Additional objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 7 Days 至 2 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Evidence of personally signed and dated informed consent document indicating that the infant's parent(s) have been informed of all pertinent aspects of the study
- •Parent(s) are willing and able to fulfill the requirements of the study protocol
- •Healthy full term (37-42 weeks gestation) infant
- •Be between post-natal age (Date of Birth = Day 0) 7 days to 2 months
- •Parent(s) must have independently elected, before enrollment, to formula feed
排除标准
- •Evidence of personally signed and dated informed consent document indicating that the infant's parent(s) have been informed of all pertinent aspects of the study
- •Parent(s) are willing and able to fulfill the requirements of the study protocol
- •Healthy full term (37-42 weeks gestation) infant
- •Be between post-natal age (Date of Birth = Day 0) 7 days to 2 months
- •Infants must have been exclusively consuming breast milk since birth, and their parent(s) must have made the decision to continue exclusively breastfeeding until at least 4 month of age
研究组 & 干预措施
Breast-fed infants
Reference group of exclusively breastfed
Formula-fed infants
Infants fed exclusively with experimental formula
干预措施: HMO-supplemented infant formula (Other)
Mixed-fed infants
Infants receiving breastmilk and experimental formula
干预措施: HMO-supplemented infant formula (Other)
结局指标
主要结局
World Health Organization (WHO) based weight-for-age z-scores
时间窗: 8 weeks (study end)
Weight-for-age z-scores using WHO growth standards
World Health Organization (WHO) based length-for-age z-scores
时间窗: 8 weeks (study end)
Length-for-age z-scores using WHO growth standards
World Health Organization (WHO) weight-for-length z-scores
时间窗: 8 weeks (study end)
Weight-for-length z-scores using WHO growth standards
World Health Organization (WHO) head-circumference-for-age z-scores
时间窗: 8 weeks (study end)
head-circumference-for-age z-scores using WHO growth standards
World Health Organization (WHO) based body-mass-index (BMI)-for-age z-scores
时间窗: 8 weeks (study end)
Weight and height will be combined to calculate BMI in kg/m\^2, then BMI-for-age z-scores will be derived using WHO growth standards
Feeding tolerance
时间窗: 8 weeks (study end)
The Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score will be used to assess GI distress. This is a validated 13-item questionnaire where each item is scored on a scale of 1 to 5 with higher values indicating greater GI distress. A composite IGSQ score is derived from summing the individual scores with a possible range of 13 to 65 where higher values indicate greater GI distress and values ≤23 indicate no digestive distress.
次要结局
- Formula acceptability(4 weeks (study midpoint), 8 weeks (study end))
- Standard adverse events (AEs) reporting for safety assessment(From the time the informed consent form has been signed at enrollment infant age less than 7 days to 2 months through the 8 weeks of intervention)
- Weight(8 weeks (study end))
- Length(8 weeks (study end))
- Head circumference(8 weeks (study end))
- Body-mass-index (BMI)(8 weeks (study end))