Actively Recruiting
Growing Little PEAPODS Study: Association Between Prematurity and Body Composition, Nutrition Practices, and Neurodevelopmental Outcomes
Led by University of Wisconsin, Madison · Updated on 2025-08-12
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Wisconsin, Madison
Lead Sponsor
M
Meriter Hospital, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to learn how the food and nutrition premature babies receive while in the Neonatal Intensive Care Unit (NICU) affect their ability to gain weight, increase fat-free mass, and their future growth and development. The study focuses on babies born between 22 and 32 weeks gestational age and will follow them for up to 36 months to assess these factors and neurodevelopmental outcomes. Premature babies in the study will be evaluated using the PEAPOD Infant Body Composition measuring device, which collects body composition measurements. Nutritional information will also be collected during the first two weeks of life. Researchers will study the relationship between nutritional intake, changes in fat-free mass, and neurodevelopmental scores using tools like the General Movement Assessment and Bayley Scales of Infant and Toddler Development. Participants and their caregivers can expect body growth measurements, nutritional data collection, and neurodevelopmental follow-up over a 36-month period. The study measures how nutrition early in life relates to physical growth and brain development. Caregivers will provide consent and agree to comply with study procedures, which include periodic assessments and use of the PEAPOD device at the hospital.
CONDITIONS
Brief Title
Growing Little PEAPODS Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Born inpatient at Meriter Hospital at or above 22 gestational weeks and up to 32 weeks 6 days gestational age
- Birthing parent speaks English or Spanish
- Birthing parent is able and willing to sign informed consent
- Birthing parent is the primary caregiver of the eligible neonate
- Birthing parent agrees to enroll neonate and comply with study procedures
- Birthing parent is age 15 or older
You will not qualify if you...
- Known genetic condition affecting neurodevelopment or brain structure
- Multiple major congenital anomalies
- Likely transfer to American Family Children's Hospital before 36 weeks postmenstrual age
- Unable to provide informed consent, including subjects in foster care or state custody
- Does not plan to maintain custody of the child after birth, such as adoption or surrogacy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Birth to 2 weeks
Premature babies are evaluated using the PEAPOD Infant Body Composition measuring device to collect body composition measurements.
1 to 2 visits depending on nutritional intake assessments
Duration - Birth to 36 months
Participants are observed and assessed for neurodevelopmental outcomes using the General Movement Assessment and Bayley Scales of Infant and Toddler Developmental Scores.
Periodic visits over 36 months for developmental assessments
Trial Site Locations
Total: 1 location
1
Meriter Hospital, Inc.
Madison, Wisconsin, United States, 53715
Actively Recruiting
Research Team
W
Whitley Hulse, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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