RecruitingNCT06226051

Growing Little PEAPODS Study

Growing Little PEAPODS Study: Association Between Prematurity and Body Composition, Nutrition Practices, and Neurodevelopmental Outcomes

Sponsor

University of Wisconsin, Madison

Enrollment

120 participants

Start Date

Sep 4, 2024

Study Type

OBSERVATIONAL

Conditions

Premature Infant Premature Birth Intrauterine Growth Restriction Small for Gestational Age at Delivery Premature

Summary

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.

Eligibility

Min Age: 22 WeeksMax Age: 32 Weeks

Inclusion Criteria7

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)
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

Exclusion Criteria6

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
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

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