Recruiting

Nutritional Influence

Sponsor:

University of Wisconsin, Madison

Code:

NCT06226051

Conditions

Premature Birth

Premature Infant

Premature

Intrauterine Growth Restriction

Small for Gestational Age at Delivery

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

PEAPOD Infant Body Composition measuring device

Study Details

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

Study ID

NCT06226051

Start date

Sep 4, 2024

Status verified date

Aug, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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)

Neonate Exclusion Criteria:

  • 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

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

PEAPOD device

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

Interventions

PEAPOD Infant Body Composition measuring device

PEAPOD is a device to that collects body composition measurements.

Primary outcome measure

  • 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 [ Time Frame: 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) [ Time Frame: Birth to 36 months ]
  • To evaluate the correlation between the percent increase in fat-free mass and the GMA and/or Bayley scores. [ Time Frame: Birth to 36 months ]

Central Contacts and Locations

Central contacts

Whitley Hulse, MD

608-620-4924whulse@wisc.edu

Locations

Meriter Hospital, Inc.

Recruiting

Madison, Wisconsin, United States, 53715

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-08-19.