Growing Little PEAPODS Study

NCT06226051 | Recruiting DMC

• 5 other identifiers: 2023-0931A536757SMPH/PEDIATRICS/PEDIATRICSProtocol Version 9/11/20242023-023
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

  The least absolute shrinkage and selection operator technique will be utilized to determine whether fat intake predicts a percent increase in fat-free mass

  Birth to 2 weeks

• 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)

  The least absolute shrinkage and selection operator technique will be utilized to determine whether higher nutritional intake predicts Bayley cognitive scores

  Birth to 36 months

• To evaluate the correlation between the percent increase in fat-free mass and the GMA and/or Bayley scores.

  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.

  Birth to 36 months

Study Arms (1)

PEAPOD device

Premature babies will be evaluated using the PEAPOD Infant Body Composition measuring device

Device: PEAPOD Infant Body Composition measuring device

Interventions

PEAPOD Infant Body Composition measuring device DEVICE

PEAPOD is a device to that collects body composition measurements.

PEAPOD device

Eligibility Criteria

• Age: 22 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

120 neonates born inpatient at Meriter Hospital, Inc. ≤ 32 weeks 6 days (32w6d) GA (possible gestational age range from 22w0d-32w6d)

You may qualify if:

• 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)

You may not qualify if:

• 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 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
• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Meriter Hospital, Inc.: collaborator

Study Sites (1)

Meriter Hospital, Inc.

Madison, Wisconsin, 53715, United States

RECRUITING

MeSH Terms

Conditions

Premature Birth; Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Whitley Hulse, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Whitley Hulse, MD

CONTACT

608-620-4924; whulse@wisc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: January 26, 2024
• Study Start: September 4, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)