Growing Little PEAPODS Study: Association Between Prematurity and Body Composition, Nutrition Practices, and Neurodevelopmental Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- To evaluate the correlation between nutritional intake over the first two weeks of life and the percent increase in fat-free mass measured by the PEAPOD
研究概览
简要总结
The goal of this clinical trial is to learn more about how the food and nutrition babies receive while in the Neonatal Intensive Care Unit (NICU) influences their ability to gain weight and fat-free mass, and their future growth and development.
Participants will:
- have body growth measurements collected using the PEAPOD device
- have nutritional information collected, and
- be followed for neurodevelopmental outcomes
Participants can expect to be in the study for 36 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonate Inclusion Criteria:
- •Born inpatient at Meriter Hospital, Inc. at or above 22 gestational weeks. Upper limit is 32 weeks 6 days GA (possible gestational age range from 22w0d-32w6d)
排除标准
- •Known genetic condition that impacts neurodevelopmental outcomes or brain structure development
- •Multiple major congenital anomalies
- •Per the investigator's opinion, the subject will likely require transfer to American Family Children's Hospital (AFCH) before 36 weeks PMA
- •Any neonate who enrolls in the study and then unexpectedly requires transfer to AFCH before 36 weeks PMA will be excluded from the study if they are unable to obtain at least one body composition measurement before transfer. Body composition data points can only be collected at Meriter Hospital due to the location of PEAPOD
- •Birthing Parent Inclusion Criteria:
- •Birthing parent must speak English or Spanish due to consent documents
- •Able to understand and willing to sign a written informed consent document
- •Primary caregiver of a neonate who is eligible to participate in the study
- •Agrees to enroll neonate into the study
- •Willing to comply with all study procedures and be available for the duration of the study
- •Age 15 or older
- •Birthing Parent Exclusion Criteria:
- •Subject is unable to provide informed consent, including subjects in foster care and subjects within state custody
- •Does not plan to maintain custody of the child after birth, such as in instances of adoption or surrogacy
研究组 & 干预措施
PEAPOD device
Premature babies will be evaluated using the PEAPOD Infant Body Composition measuring device
干预措施: PEAPOD Infant Body Composition measuring device (Device)
结局指标
主要结局
To evaluate the correlation between nutritional intake over the first two weeks of life and the percent increase in fat-free mass measured by the PEAPOD
时间窗: Birth to 2 weeks
The least absolute shrinkage and selection operator technique will be utilized to determine whether fat intake predicts a percent increase in fat-free mass
To evaluate the correlation between higher nutritional intake in the first 2 weeks of life and the General Movement Assessment (GMA) and/or the Bayley Scales of Infant and Toddler Developmental Scores (Bayley)
时间窗: Birth to 36 months
The least absolute shrinkage and selection operator technique will be utilized to determine whether higher nutritional intake predicts Bayley cognitive scores
To evaluate the correlation between the percent increase in fat-free mass and the GMA and/or Bayley scores.
时间窗: Birth to 36 months
The least absolute shrinkage and selection operator technique will be utilized to determine whether the percent increase in fat-free mass predicts GMA scores and Bayley scores.
次要结局
未报告次要终点