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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 4 months
Healthy Volunteers: No
View:

• Late preterm (at or above 35 weeks gestation) and term infants

• Admitted to the NICU

• Diagnosed with congenital gastrointestinal anomalies, defined as gastroschisis, omphalocele, esophageal and bowel atresias, tracheoesophageal fistulas, Hirschsprung's disease, or congenital diaphragmatic hernias.

Locations
United States
Minnesota
Children's Minnesota
Recruiting
Minneapolis
Contact Information
Primary
Erin Plummer, MD
erin.plummer@childrensmn.org
651-220-6264
Time Frame
Start Date: December 20, 2019
Estimated Completion Date: December 31, 2023
Participants
Target number of participants: 40
Related Therapeutic Areas
Sponsors
Leads: Children's Hospitals and Clinics of Minnesota
Collaborators: University of Minnesota

This content was sourced from clinicaltrials.gov

Similar Clinical Trials