Growing Little PEAPODS Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22-32
SponsorUniversity of Wisconsin, Madison

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial population

120 neonates born inpatient at Meriter Hospital, Inc. ≤ 32 weeks 6 days (32w6d) GA (possible gestational age range from 22w0d-32w6d)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • PEAPOD Infant Body Composition measuring device

    Device

    PEAPOD is a device to that collects body composition measurements.

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: PEAPOD device1 intervention

Trial outcomes

Primary outcomes

1

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

The least absolute shrinkage and selection operator technique will be utilized to determine whether fat intake predicts a percent increase in fat-free mass

Time frame
Birth to 2 weeks
2

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)

The least absolute shrinkage and selection operator technique will be utilized to determine whether higher nutritional intake predicts Bayley cognitive scores

Time frame
Birth to 36 months
3

To evaluate the correlation between the percent increase in fat-free mass and the GMA and/or Bayley scores.

The least absolute shrinkage and selection operator technique will be utilized to determine whether the percent increase in fat-free mass predicts GMA scores and Bayley scores.

Time frame
Birth to 36 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Wisconsin, Madison

Lead sponsor

Meriter Hospital, Inc.

Collaborator