Understanding how nutrition affects growth in premature infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.