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

March 8, 2022 updated by: Children's Hospitals and Clinics of Minnesota
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Infants with congenital gastrointestinal anomalies (CGIA) including gastroschisis, omphalocele, esophageal and bowel atresias, tracheoesophageal fistulas, Hirschsprung's disease, and congenital diaphragmatic hernias, account for ~7 in 10,000 live births. Early in life, these infants undergo major surgery under general anesthesia followed by a prolonged period of inadequate nutrition, exposure to post-operative pain medications and antibiotics, and parental separation. Despite exposure to these risk factors for future growth failure and neurodevelopmental delay, growth and neurodevelopmental outcomes have not been well described in this group of at-risk infants. Preliminary findings in preschool-age children with CGIA suggest that these children have slower speed of processing compared to healthy children and that increased fat-free mass (FFM) at preschool age is associated with higher cognitive test scores. However, no studies to date have described the longitudinal relationship between growth, body composition, nutrition, inflammation, and neurodevelopmental outcomes in infants with CGIA. To address this research gap, the investigators propose to conduct a prospective cohort study enrolling infants with CGIA to measure their growth and development over time. Infant growth and body composition will be measured at or near term and at 4 months corrected age.

The investigators hypothesize that infants with CGIA will undergo a period of rapid catch-up growth early in life, and infants who demonstrate better catch-up growth will have better neurodevelopmental outcomes compared to infants that do not experience catch-up growth. At 4 months corrected age, early neurologic outcomes will be measured using event related potentials (ERP). Clinical information including nutrient intake, inflammatory markers, and medications received will be gathered throughout the neonatal intensive care unit (NICU) hospitalization to assess the impact physiologic stressors have on changes in body composition and cognitive outcomes.

The objective of this study is to determine the impact of early nutrition, inflammation, physiologic stress, growth, and body composition on later neurodevelopmental outcomes in infants requiring neonatal surgery for CGIA.

Specific aims include:

Aim 1. To determine if infants with CGIA requiring neonatal surgery have altered body composition growth patterns compared to healthy infants.

Aim 1a. To determine if early physiologic stress and/or malnutrition are associated with altered body composition in infants with CGIA compared to healthy infants.

Hypothesis: CGIA infants with increased early nutritional intake and decreased inflammation will have greater FFM gains and more appropriately mimic the growth of healthy comparison infants.

Aim 2. To determine if FFM gains in infancy are associated with improved neurodevelopmental outcomes among infants with CGIA.

Hypothesis: Greater FFM gains from birth to 4 months corrected age will be associated with faster speed of processing and better recognition memory among infants with CGIA.

The investigators hypothesize that early exposure to physiologic stressors impact the framework of the developing brain leading to long-lasting changes in development and that FFM accretion is an important biomarker of long-term outcomes for this population. The investigators hope to discover methods to better identify those infants at risk for poor neurodevelopmental outcomes and provide improved recommendations regarding nutritional and educational interventions that will ensure these infants achieve their full potential. These findings could also be used to encourage local and national NICU follow-up programs to expand beyond the follow-up of preterm infants to include high-risk populations such as infants born with CGIA. In addition, this proposed study could greatly impact community population health by optimizing growth and neurodevelopmental outcomes in children previously hospitalized in NICUs.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 second to 4 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Growth
Time Frame: At term equivalence and at 4 months corrected age
Anthropometric and body composition measurements
At term equivalence and at 4 months corrected age

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Neurodevelopment
Time Frame: At 4 months
Neurodevelopmental measures, defined as speed of processing, as associated with body composition
At 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospitals and Clinics of Minnesota

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Minnesota

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Erin Plummer, MD, Children's Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1910-132

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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