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NCT Number: NCT06226051

Growing Little PEAPODS Study

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.

Recruiting

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Key information

Conditions

Premature Birth Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Fetal Growth Retardation Growth Disorders Intrauterine Growth Restriction Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Premature Infant Small for Gestational Age at Delivery Urogenital Diseases

Age range

22 week–32 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Meriter Hospital, Inc.

Madison, Wisconsin, 53715, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEAPOD Infant Body Composition measuring device

Device

PEAPOD is a device to that collects body composition measurements.

Primary outcomes

  1. 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

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

  2. 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

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

  3. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Whitley Hulse, MD

CONTACT

[email protected]

608-620-4924

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Meriter Hospital, Inc.

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jan 26, 2024
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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