RecruitingNot Applicable

Growing Little PEAPODS Study

United States120 participantsStarted 2024-09-04

Plain-language summary

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.

Who can participate

Age range22 Weeks – 32 Weeks

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 s…

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

Timeframe: 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)

Timeframe: Birth to 36 months

To evaluate the correlation between the percent increase in fat-free mass and the GMA and/or Bayley scores.

Timeframe: Birth to 36 months

Trial details

NCT IDNCT06226051

SponsorUniversity of Wisconsin, Madison

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-01

Contact for this trial

Whitley Hulse, MD

608-620-4924 whulse@wisc.edu

View on ClinicalTrials.gov More Premature Birth trials

Plain-language summary

Who can participate

Age range22 Weeks – 32 Weeks

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Timeframe: Birth to 2 weeks

Timeframe: Birth to 36 months

To evaluate the correlation between the percent increase in fat-free mass and the GMA and/or Bayley scores.

Timeframe: Birth to 36 months