Growing Little PEAPODS Study for Premature Infants

This observational study, called the Growing Little PEAPODS Study, aims to understand how nutrition in the Neonatal Intensive Care Unit (NICU) affects the growth and development of premature babies. Researchers will use a device called PEAPOD to measure body composition (how much fat and fat-free mass a baby has). They will look at how nutritional intake in the first two weeks of life relates to changes in fat-free mass and later developmental scores. The study is looking for 120 premature infants born between 22 and 32 weeks of gestation at Meriter Hospital, Inc. The goal is to see if better nutrition leads to better growth and development outcomes up to 36 months of age.

Study design: This is an observational study with a planned enrollment of 120 participants. It is not a randomized or blinded study.
What's involved: Participants will have body growth measurements collected using the PEAPOD device, nutritional information collected, and will be followed for neurodevelopmental outcomes. Participants can expect to be in the study for 36 months.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for neurodevelopmental outcomes for 36 months.

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Growing Little PEAPODS Study

Recruiting

Not specifiedAges 22–32Observational

University of Wisconsin, Madison

~120 participants

Updated 2026-08-19 on ClinicalTrials.gov

What's tested:PEAPOD Infant Body Composition measuring device

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

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

Measured over Birth to 2 weeks

+2 more outcomes measured

Conditions

Premature Birth

Premature Infant

Premature

Intrauterine Growth Restriction

Small for Gestational Age at Delivery

Where it's being run

1 sites across 1 states

Wisconsin1

Study leadership

Whitley Hulse, MD · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Madison

Who to contact

Whitley Hulse, MD

[email protected]

608-620-4924

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Eligibility criteria

Inclusion

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

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

What this trial measures

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 PEAPODBirth 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)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.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.

Trialytics