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

NCT04575649 | Unknown DMC

• 1 other identifier: 1910-132
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastrointestinal Disease

Keywords

Body composition

Outcome Measures

Primary Outcomes (1)

• Growth

  Anthropometric and body composition measurements

  At term equivalence and at 4 months corrected age

Secondary Outcomes (1)

• Neurodevelopment

  At 4 months

Interventions

Gastrointestinal anomalies OTHER

Infants born late preterm (at or above 35 weeks gestation) and term infants admitted to the NICU with congenital gastrointestinal anomalies, including gastroschisis, omphalocele, esophageal and bowel artesias, tracheoesophageal fistulas, Hirschsprung's disease, or congenital diaphragmatic hernias.

Eligibility Criteria

• Age: 0 Days - 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants admitted to the NICU at University of Minnesota Masonic Children's Hospital, Children's Minnesota - St. Paul, or Children's Minnesota - Minneapolis.

You may qualify if:

• 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.

You may not qualify if:

• Infants born before 35 weeks gestation
• Infants with cardiac defects requiring intervention
• Infants with known chromosomal abnormalities that affect growth or cognition
• Infant born to families that are non-English speaking due to lack of interpreter services available

Sponsors & Collaborators

• Children's Hospitals and Clinics of Minnesota: lead
• University of Minnesota: collaborator

Study Sites (1)

Children's Minnesota

Minneapolis, Minnesota, 55404, United States

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Erin Plummer, MD

  Children's Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Plummer, MD

CONTACT

651-220-6264; erin.plummer@childrensmn.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 5, 2020
• Study Start: December 20, 2019
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 9, 2022

Record last verified: 2022-03

Locations

US (1)