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 range

22 Weeks – 32 Weeks

Sex

ALL

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

22 Weeks – 32 Weeks

Sex

ALL

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