The Impact of Pre-Pregnancy Weight Loss on Infant Sucking Behavior in Response to a Challenging Nipple
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Suck effect
研究概览
简要总结
This study will help researchers learn more about how babies respond to bottle nipples with larger or smaller holes. Researchers guess that infants of mothers with obesity who did not lose weight prior to pregnancy will have the greatest Suck Effect on the challenging compared with the typical nipple.
详细描述
The researchers will recruit babies from the original cohort in the PLAN study (NCT03244722), regardless of which arms they participated in. However, the researchers will test the study arms from the original PLAN study for effects on the study's dependent variables. Their between-subjects arms included Pre-pregnancy obesity with intensive weight loss intervention, pre-pregnancy obesity with standard of care intervention, and pre-pregnancy healthy weight with no intervention. So, although the researchers are not assigning babies to any arms, their original assignment will still be assessed the study analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
Order of nipple size use is counter-balanced, caregivers are blind to nipple size and amount of milk in the bottle (i.e., the bottle is covered) to minimize their influence over the infant's consumption. Research assistants will not be blind to nipple size as they will need to set the bottles ups for the mothers.
入排标准
- 年龄范围
- 3 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To be eligible to participate in this study...
- •Current or previous participation in the PLAN study resulting in a live birth.
- •Mother participated in PLAN study during child's gestation
- •Infant birth weight (From PLAN study records) appropriate (≥ 3rd percentile and ≤ 97th percentile) for gestational age and sex based on US Natality Data set (Oken et al, BMC Pediatrics 2003).
- •Infant is 3.0 to 6.0 months old at Consent.
- •Biological mother is legal guardian by maternal report.
- •Biological mother is full time custodial guardian by maternal report (versus sharing custody such that infant does not live with her full time).
- •Infant typically consumes at least 2 ounces in one feeding from an artificial nipple and bottle at least once per week by maternal report.
- •Stated willingness by mother to comply with all study procedures and availability for the duration of the study.
排除标准
- 未提供
研究组 & 干预措施
Nipple order 2
First the challenging nipple and then the typical nipple
干预措施: Typical Nipple (Behavioral)
Nipple order 1
First the typical nipple and then challenging nipple
干预措施: Typical Nipple (Behavioral)
Nipple order 1
First the typical nipple and then challenging nipple
干预措施: Challenging Nipple (Behavioral)
Nipple order 2
First the challenging nipple and then the typical nipple
干预措施: Challenging Nipple (Behavioral)
结局指标
主要结局
Suck effect
时间窗: Up to 6 weeks
Sucking will be measured with the NFANT® Feeding Solution
次要结局
- Total Night Wake-ups within 24 hours of intervention(Up to 6 weeks)
- Milk/Formula consumption rate(Up to 6 weeks)
- Sucking pressure(Up to 6 weeks)
- Sucking frequency(Up to 6 weeks)
- Milk/Formula intake(Up to 6 weeks)
- Number of Feedings Over 24 Hours(Up to 6 weeks)
- Total Hours of Sleep per 24 Hours within 24 hours of intervention(Up to 6 weeks)
研究者
Amanda Kinney Crandall
Research Fellow, Pediatrics
University of Michigan