Understanding how nutrition affects growth in premature infants
Growing Little PEAPODS Study: Association Between Prematurity and Body Composition, Nutrition Practices, and Neurodevelopmental Outcomes
This study looks at how the food that premature babies eat in the NICU affects their growth and development over three years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 22 Weeks to 32 Weeks |
| Sex | All |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT06226051 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the impact of nutrition on the growth and development of premature infants in the Neonatal Intensive Care Unit (NICU). Participants will have their body growth measurements taken using the PEAPOD device, and nutritional information will be collected to assess its influence on weight gain and fat-free mass. The study will follow these infants for neurodevelopmental outcomes over a period of 36 months.
Who should consider this trial
Good fit: Ideal candidates for this study are neonates born at Meriter Hospital between 22 and 32 weeks of gestational age.
Not a fit: Patients with known genetic conditions affecting neurodevelopment or those requiring transfer to another hospital before 36 weeks post-menstrual age may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved nutritional strategies that enhance growth and development in premature infants.
How similar studies have performed: While similar studies have explored nutrition in premature infants, this specific approach using the PEAPOD device for body composition measurement is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Madison, Wisconsin
- Meriter Hospital, Inc. — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Whitley Hulse, MD — University of Wisconsin, Madison
- Study coordinator: Whitley Hulse, MD
- Email: whulse@wisc.edu
- Phone: 608-620-4924
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.