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Recruiting NCT06226051

Growing Little PEAPODS Study

— Observational Premature Birth Premature Infant Premature Intrauterine Growth Restriction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PEAPOD Infant Body Composition measuring device.
Who it may be relevant to
Registry conditions: Premature Birth, Premature Infant, Premature, Intrauterine Growth Restriction. Basic parameters: 22 Weeks — 32 Weeks · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device PEAPOD Infant Body Composition measuring device
    PEAPOD is a device to that collects body composition measurements.

Primary outcome 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 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Meriter Hospital, Inc. — Madison

Identifiers

NCT: NCT06226051 · 2023-0931 · A536757 · SMPH/PEDIATRICS/PEDIATRICS · Protocol Version 9/11/2024 · 2023-023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗