RECRUITING

Growing Little PEAPODS Study

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Conditions

Premature BirthPremature InfantPrematureIntrauterine Growth RestrictionSmall for Gestational Age At Delivery

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-09-04
Study Completion:2027-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06226051

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Weeks to 32 Weeks
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * 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)
  1. * Known genetic condition that impacts neurodevelopmental outcomes or brain structure development
  2. * Multiple major congenital anomalies
  3. * Per the investigator's opinion, the subject will likely require transfer to American Family Children's Hospital (AFCH) before 36 weeks PMA
  4. * 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

Contacts and Locations

Study Contact

Whitley Hulse, MD
CONTACT
608-620-4924
whulse@wisc.edu

Principal Investigator

Whitley Hulse, MD
PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Wisconsin, Madison

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-04
Study Completion Date2027-01

Study Record Updates

Study Start Date2024-09-04
Study Completion Date2027-01

Terms related to this study

Additional Relevant MeSH Terms

  • Premature Birth
  • Premature Infant
  • Premature
  • Intrauterine Growth Restriction
  • Small for Gestational Age At Delivery