Growing Little PEAPODS Study
Launched by UNIVERSITY OF WISCONSIN, MADISON · Jan 17, 2024

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Nctid: NCT06226051

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"relevance"=>"LOW"}, {"id"=>"M10764", "name"=>"Obstetric Labor Complications", "relevance"=>"LOW"}, {"id"=>"M14127", "name"=>"Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M27093", "name"=>"Female Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M8399", "name"=>"Female Urogenital Diseases and Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M8445", "name"=>"Fetal Diseases", "relevance"=>"LOW"}, {"id"=>"M9230", "name"=>"Growth Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Diseases and Abnormalities at or Before Birth", "abbrev"=>"BC16"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>120}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-09-04", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2027-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-12-03", "studyFirstSubmitDate"=>"2024-01-17", "studyFirstSubmitQcDate"=>"2024-01-17", "lastUpdatePostDateStruct"=>{"date"=>"2024-12-04", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2027-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"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", "timeFrame"=>"Birth to 2 weeks", "description"=>"The least absolute shrinkage and selection operator technique will be utilized to determine whether fat intake predicts a percent increase in fat-free mass"}, {"measure"=>"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)", "timeFrame"=>"Birth to 36 months", "description"=>"The least absolute shrinkage and selection operator technique will be utilized to determine whether higher nutritional intake predicts Bayley cognitive scores"}, {"measure"=>"To evaluate the correlation between the percent increase in fat-free mass and the GMA and/or Bayley scores.", "timeFrame"=>"Birth to 36 months", "description"=>"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."}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Premature Birth", "Premature Infant", "Premature", "Intrauterine Growth Restriction", "Small for Gestational Age At Delivery"]}, "descriptionModule"=>{"briefSummary"=>"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.\n\nParticipants will:\n\n* have body growth measurements collected using the PEAPOD device\n* have nutritional information collected, and\n* be followed for neurodevelopmental outcomes\n\nParticipants can expect to be in the study for 36 months."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD"], "maximumAge"=>"32 weeks", "minimumAge"=>"22 weeks", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"120 neonates born inpatient at Meriter Hospital, Inc. ≤ 32 weeks 6 days (32w6d) GA (possible gestational age range from 22w0d-32w6d)", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Neonate Inclusion Criteria:\n\n* 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)\n\nNeonate Exclusion Criteria:\n\n* Known genetic condition that impacts neurodevelopmental outcomes or brain structure development\n* Multiple major congenital anomalies\n* Per the investigator's opinion, the subject will likely require transfer to American Family Children's Hospital (AFCH) before 36 weeks PMA\n\n * 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\n\nBirthing Parent Inclusion Criteria:\n\n* Birthing parent must speak English or Spanish due to consent documents\n* Able to understand and willing to sign a written informed consent document\n* Primary caregiver of a neonate who is eligible to participate in the study\n* Agrees to enroll neonate into the study\n* Willing to comply with all study procedures and be available for the duration of the study\n* Age 15 or older\n\nBirthing Parent Exclusion Criteria:\n\n* Subject is unable to provide informed consent, including subjects in foster care and subjects within state custody\n* Does not plan to maintain custody of the child after birth, such as in instances of adoption or surrogacy"}, "identificationModule"=>{"nctId"=>"NCT06226051", "briefTitle"=>"Growing Little PEAPODS Study", "organization"=>{"class"=>"OTHER", "fullName"=>"University of Wisconsin, Madison"}, "officialTitle"=>"Growing Little PEAPODS Study: Association Between Prematurity and Body Composition, Nutrition Practices, and Neurodevelopmental Outcomes", "orgStudyIdInfo"=>{"id"=>"2023-0931"}, "secondaryIdInfos"=>[{"id"=>"A536757", "type"=>"OTHER", "domain"=>"UW Madison"}, {"id"=>"SMPH/PEDIATRICS/PEDIATRICS", "type"=>"OTHER", "domain"=>"UW Madison"}, {"id"=>"Protocol Version 4/13/2024", "type"=>"OTHER", "domain"=>"UW Madison"}, {"id"=>"2023-023", "type"=>"OTHER", "domain"=>"Meriter"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"PEAPOD device", "description"=>"Premature babies will be evaluated using the PEAPOD Infant Body Composition measuring device", "interventionNames"=>["Device: PEAPOD Infant Body Composition measuring device"]}], "interventions"=>[{"name"=>"PEAPOD Infant Body Composition measuring device", "type"=>"DEVICE", "description"=>"PEAPOD is a device to that collects body composition measurements.", "armGroupLabels"=>["PEAPOD device"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"53715", "city"=>"Madison", "state"=>"Wisconsin", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Meriter Hospital, Inc.", "geoPoint"=>{"lat"=>43.07305, "lon"=>-89.40123}}], "centralContacts"=>[{"name"=>"Whitley Hulse, MD", "role"=>"CONTACT", "email"=>"whulse@wisc.edu", "phone"=>"608-620-4924"}], "overallOfficials"=>[{"name"=>"Whitley Hulse, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"University of Wisconsin, Madison"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University of Wisconsin, Madison", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Meriter Hospital, Inc.", "class"=>"UNKNOWN"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}

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Trial Information

Current as of December 21, 2024

Recruiting

Keywords

ClinConnect Summary

The Growing Little PEAPODS Study is a clinical trial aimed at understanding how the nutrition that premature infants receive while they are in the Neonatal Intensive Care Unit (NICU) affects their growth and development. Researchers want to see how the food these babies eat helps them gain weight and develop properly over time. The study will track body growth using a special device and gather information about the babies' nutrition and their future development over the course of 36 months.

To participate, babies need to be born at Meriter Hospital between 22 and 32 weeks of gestation and must not have certain genetic conditions or serious birth defects. The baby's primary caregiver, who must be at least 15 years old and speak English or Spanish, will need to agree to the study and provide consent. Throughout the study, caregivers can expect to help with body measurements and provide information about the baby's diet while they are in the NICU. This research is important as it aims to improve the care and outcomes for premature infants in the future.

Gender

ALL

Eligibility 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 Officials

Whitley Hulse, MD

Principal Investigator

University of Wisconsin, Madison

About University Of Wisconsin, Madison

The University of Wisconsin-Madison is a leading research institution renowned for its commitment to advancing healthcare through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, the university leverages its extensive resources, including cutting-edge facilities and a diverse pool of expert researchers, to conduct rigorous studies that address critical health challenges. The institution's focus on translating research findings into practical applications fosters the development of new treatments and interventions, ultimately contributing to improved patient outcomes and public health initiatives. As a sponsor of clinical trials, the University of Wisconsin-Madison is dedicated to upholding the highest ethical standards and ensuring participant safety throughout the research process.

Locations

Madison, Wisconsin, United States

People applied

0 patients applied

Timeline

First submit

January 17, 2024

Trial launched

September 04, 2024

Trial updated

December 03, 2024

Estimated completion

Not reported

Discussion 0

Growing Little PEAPODS Study Launched by UNIVERSITY OF WISCONSIN, MADISON · Jan 17, 2024

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Growing Little PEAPODS Study
Launched by UNIVERSITY OF WISCONSIN, MADISON · Jan 17, 2024