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Neurodevelopmental Outcomes and Growth in Infants With Congenital Gastrointestinal Anomalies Requiring Neonatal Surgery

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clinicaltrials.gov/study/NCT04575649
Is a
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Clinical study
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Clinical Study attributes

NCT Number
NCT045756490
Health Conditions in Trial
Gastrointestinal disease
Gastrointestinal disease
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Trial Recruitment Size
400
Trial Sponsor
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Children's Hospitals and Clinics of Minnesota
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Trial Collaborator
University of Minnesota
University of Minnesota
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Clinical Trial Start Date
December 20, 2019
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Primary Completion Date
October 31, 2023
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Study Completion Date
December 31, 2023
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Clinical Trial Study Type
Observational0
Observational Clinical Trial Type
Cohort0
Observational Study Perspective
Prospective0
Participating Facility
Children's Minnesota
Children's Minnesota
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Official Name
Neurodevelopmental Outcomes and Growth in Infants With Congenital Gastrointestinal Anomalies Requiring Neonatal Surgery0
Last Updated
March 9, 2022
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Study summary

Infants with congenital gastrointestinal anomalies (CGIA) experience multiple physiologic stressors, including neonatal surgery, early in life during an essential time of growth and development. Early physiologic stressors such as inadequate nutrition have been linked to altered growth patterns and neurodevelopmental delays later in life. In other groups of at-risk infants, early body composition measurements can be used as predictors of long-term health outcomes more so than weight and length alone. The primary objective of this study is to determine if body composition changes in early life are predictive of neurodevelopmental outcomes among infants with CGIA. The secondary objective is to determine if infants with CGIA have altered body composition over time when compared with healthy infants. The investigators propose a prospective, observational study of infants with CGIA, including detailed chart review, body composition measurements, and neurodevelopmental testing at follow-up. If a correlation between body composition measurements and neurodevelopmental outcomes is established in this population, the addition of body composition measurement to standard of care in the neonatal intensive care unit and in follow-up care could allow for further optimization of overall health and development of this vulnerable pediatric population through earlier detection of growth alterations and informed interventions.

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