Premature BirthNCT06226051
Growing Little PEAPODS Study
An observational study of Premature Birth and Premature Infant, run by University of Wisconsin, Madison at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 22 to 32 weeks
- Conditions the study is for
- Premature Birth, Premature Infant, Premature
- What is being tested?
- PEAPOD Infant Body Composition measuring device
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2024to Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Study population: 120 neonates born inpatient at Meriter Hospital, Inc. ≤ 32 weeks 6 days (32w6d) GA (possible gestational age range from 22w0d-32w6d)
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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Meriter Hospital, Inc.
Madison, Wisconsin, 53715
About this study
Official title: Growing Little PEAPODS Study: Association Between Prematurity and Body Composition, Nutrition Practices, and Neurodevelopmental Outcomes
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.
- Conditions
- Premature Birth, Premature Infant, Premature, Intrauterine Growth Restriction, Small for Gestational Age at Delivery
- Being tested
- PEAPOD Infant Body Composition measuring device
- Medical subject headings
- Premature Birth, Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEAPOD Infant Body Composition measuring deviceDevice
PEAPOD is a device to that collects body composition measurements.
| Study group | Role | What they receive |
|---|---|---|
| PEAPOD device | Premature babies will be evaluated using the PEAPOD Infant Body Composition measuring device Receives: Device: PEAPOD Infant Body Composition measuring device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Birth to 2 weeks
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
Measured: Birth to 36 months
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.
Measured: Birth to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start4 Sep 2024
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Meriter Hospital, Inc.
- Responsible party
- Sponsor
- Investigators
- Whitley Hulse, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06226051
- Sponsor's protocol ID
- 2023-0931
- Other IDs
- A536757, SMPH/PEDIATRICS/PEDIATRICS, Protocol Version 2/5/2026, 2023-023
- Status last verified
- Aug 2026
- First submitted
- 17 Jan 2024
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growing Little PEAPODS Study: Association Between Prematurity and Body Composition, Nutrition Practices, and Neurodevelopmental Outcomes
- ClinicalTrials.gov ID
- NCT06226051
- Acronym / sponsor ID
- 2023-0931
- Conditions
- Premature Birth, Premature Infant, Premature, Intrauterine Growth Restriction, Small for Gestational Age at Delivery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Meriter Hospital, Inc.
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 26 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEAPOD device | – | Device: PEAPOD Infant Body Composition measuring devicePremature babies will be evaluated using the PEAPOD Infant Body Composition measuring device |
Who may qualify
- Ages
- 22 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 120 neonates born inpatient at Meriter Hospital, Inc. ≤ 32 weeks 6 days (32w6d) GA (possible gestational age range from 22w0d-32w6d)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEAPOD Infant Body Composition measuring devicePEAPOD is a device to that collects body composition measurements. | Device | PEAPOD device |
Primary outcome
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
Time frame: Birth to 2 weeks
The least absolute shrinkage and selection operator technique will be utilized to determine whether fat intake predicts a percent increase in fat-free mass
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)
Time frame: Birth to 36 months
The least absolute shrinkage and selection operator technique will be utilized to determine whether higher nutritional intake predicts Bayley cognitive scores
To evaluate the correlation between the percent increase in fat-free mass and the GMA and/or Bayley scores.
Time frame: Birth to 36 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Whitley Hulse, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Birth and Premature Infant, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Whitley Hulse, MD (608-620-4924, whulse@wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Birth to 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.