Growing Little PEAPODS Study

Launched by UNIVERSITY OF WISCONSIN, MADISON · Jan 17, 2024

Keywords

ClinConnect Summary

The Growing Little PEAPODS Study is a clinical trial aimed at understanding how the nutrition that premature infants receive while they are in the Neonatal Intensive Care Unit (NICU) affects their growth and development. Researchers want to see how the food these babies eat helps them gain weight and develop properly over time. The study will track body growth using a special device and gather information about the babies' nutrition and their future development over the course of 36 months.

To participate, babies need to be born at Meriter Hospital between 22 and 32 weeks of gestation and must not have certain genetic conditions or serious birth defects. The baby's primary caregiver, who must be at least 15 years old and speak English or Spanish, will need to agree to the study and provide consent. Throughout the study, caregivers can expect to help with body measurements and provide information about the baby's diet while they are in the NICU. This research is important as it aims to improve the care and outcomes for premature infants in the future.

Gender

ALL

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