| NCT ID | NCT06226051 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Wisconsin, Madison |
| Condition | Premature Birth |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-09-04 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2024-09-04 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Whitley Hulse, MD
PRINCIPAL INVESTIGATOR
University of Wisconsin, Madison
Frequently Asked Questions
Who can join the NCT06226051 clinical trial?
This trial is open to participants of all sexes, aged 22 Weeks or older, up to 32 Weeks, studying Premature Birth. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06226051 currently recruiting?
Yes, NCT06226051 is actively recruiting participants. Contact the research team at whulse@wisc.edu for enrollment information.
Where is the NCT06226051 trial being conducted?
This trial is being conducted at Madison, United States.
Who is sponsoring the NCT06226051 clinical trial?
NCT06226051 is sponsored by University of Wisconsin, Madison. The principal investigator is Whitley Hulse, MD at University of Wisconsin, Madison. The trial plans to enroll 120 participants.