Recruiting

Observational Study

Sponsor:

Children's Hospitals and Clinics of Minnesota

Code:

NCT04575649

Conditions

Gastrointestinal Disease

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Gastrointestinal anomalies

Study Details

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

Study ID

NCT04575649

Start date

Dec 20, 2019

Status verified date

Mar, 2022

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Oct 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Interventions

Gastrointestinal anomalies

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.

Primary outcome measure

  • Growth [ Time Frame: At term equivalence and at 4 months corrected age ]

Central Contacts and Locations

Central contacts

Erin Plummer, MD

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

Locations

Children's Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55404

Contacts

Erin Plummer, MD

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

More Information

Sponsor

Children's Hospitals and Clinics of Minnesota

Last update posted

Mar 9, 2022

Last verified

Mar, 2022

Keywords

  • Body composition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospitals and Clinics of Minnesota on 2022-03-09.