Growing Little PEAPODS Study

University of Wisconsin (UW)

Status: Begins enrollment this month

Conditions: Premature; Intrauterine Growth Restriction; Small for Gestational Age at Delivery; Premature Infant; Premature Birth

Treatments: Device: PEAPOD Infant Body Composition measuring device

Study type: Observational

Funder types: Other

Identifiers

NCT06226051

2023-023

SMPH/PEDIATRICS/PEDIATRICS (Other Identifier)

2023-0931

Protocol Version 4/13/2024 (Other Identifier)

A536757 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 22 to 32 weeks old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

120 participants in 1 patient group

PEAPOD device

Description:

Premature babies will be evaluated using the PEAPOD Infant Body Composition measuring device

Treatment:

Device: PEAPOD Infant Body Composition measuring device