Growing Little PEAPODS Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-04

Study Completion Date

2028-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PEAPOD device

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

PEAPOD Infant Body Composition measuring device

Intervention Type DEVICE

PEAPOD is a device to that collects body composition measurements.

Interventions

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PEAPOD Infant Body Composition measuring device

PEAPOD is a device to that collects body composition measurements.

Intervention Type DEVICE

Eligibility Criteria

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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)

* 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

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

* 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

Minimum Eligible Age

22 Weeks

Maximum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No