Clinical trial NCT06226051: Growing Little PEAPODS Study
Official title: Growing Little PEAPODS Study: Association Between Prematurity and Body Composition, Nutrition Practices, and Neurodevelopmental Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Premature Birth
Premature Infant
Premature
Intrauterine Growth Restriction
Small for Gestational Age At Delivery
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Meriter Hospital, Inc.
First posted: 2024-01-26
Enrollment: 120
Sex: ALL
Minimum age (years): 22
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 120 neonates born inpatient at Meriter Hospital, Inc. ≤ 32 weeks 6 days (32w6d) GA (possible gestational age range from 22w0d-32w6d)

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

Primary outcomes:
measure: 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
measure: 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
measure: To evaluate the correlation between the percent increase in fat-free mass and the GMA and/or Bayley scores.
timeFrame: Birth to 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: Meriter Hospital, Inc.
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Whitley Hulse, MD
role: PRINCIPAL_INVESTIGATOR
References: