Growing Little PEAPODS Study

Premature Birth Clinical Trial

Official title:

Growing Little PEAPODS Study: Association Between Prematurity and Body Composition, Nutrition Practices, and Neurodevelopmental Outcomes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06226051
• Other study ID #: 2023-0931
• Secondary ID: A536757SMPH/PEDI
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: January 2027

Study information

• Verified date: May 2024
• Source: University of Wisconsin, Madison
• Contact: Whitley Hulse, MD
• Phone: 608-620-4924
• Email: whulse[@]wisc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: January 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Weeks to 32 Weeks

Eligibility

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

• Not suitable for study participation due to other reasons at the discretion of the investigator

Related Conditions & MeSH terms

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

Intervention

Device:
• PEAPOD Infant Body Composition measuring device
PEAPOD is a device to that collects body composition measurements.

Locations

Country	Name	City	State
United States	Meriter Hospital, Inc.	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Meriter Hospital, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Birth to 2 weeks
Primary	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	Birth to 36 months
Primary	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.	Birth to 36 months