Growing Little PEAPODS Study

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Premature Birth; Intrauterine Growth Restriction; Premature Infant; Premature; Small for Gestational Age at Delivery
• Intervention / Treatment: Device: PEAPOD Infant Body Composition measuring device

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Whitley Hulse, MD; Phone Number: 608-620-4924; Email: whulse@wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53715
      • Meriter Hospital, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• 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)

Description

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
• Not suitable for study participation due to other reasons at the discretion of the investigator

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PEAPOD device; Premature babies will be evaluated using the PEAPOD Infant Body Composition measuring device	Device: PEAPOD Infant Body Composition measuring device; PEAPOD is a device to that collects body composition measurements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: Meriter Hospital, Inc.
• Investigators: Principal Investigator: Whitley Hulse, MD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: January 17, 2024
• First Submitted That Met QC Criteria: January 17, 2024
• First Posted (Actual): January 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fetal Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Growth Disorders; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth; Fetal Growth Retardation
• Other Study ID Numbers: 2023-0931; 2023-023 (Other Identifier: Meriter); A536757 (Other Identifier: UW Madison); SMPH/PEDIATRICS/PEDIATRICS (Other Identifier: UW Madison); Protocol Version 11/20/2023 (Other Identifier: UW- Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No