Gastrointestinal DiseaseNOGINSNCT04575649
Neurodevelopmental Outcomes and Growth in Infants With Congenital Gastrointestinal Anomalies Requiring Neonatal Surgery
An observational study of Gastrointestinal Disease, run by Children's Hospitals and Clinics of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 days to 4 months
- Conditions the study is for
- Gastrointestinal Disease
- What is being tested?
- Gastrointestinal anomalies
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2019to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 4 months
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Children's Minnesota
Minneapolis, Minnesota, 55404
Erin Plummer, MD, 651-220-6264, erin.plummer@childrensmn.org
About this study
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.
Read the 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.
- Conditions
- Gastrointestinal Disease
- Being tested
- Gastrointestinal anomalies
- Keywords
- Body composition
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastrointestinal anomaliesOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth
Anthropometric and body composition measurements
Measured: At term equivalence and at 4 months corrected age
Secondary outcomes (1)
Neurodevelopment
Neurodevelopmental measures, defined as speed of processing, as associated with body composition
Measured: At 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start20 Dec 2019
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospitals and Clinics of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota
- Responsible party
- Sponsor
- Investigators
- Erin Plummer, MD, Principal investigator, Children's Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04575649
- Sponsor's protocol ID
- 1910-132
- Acronym
- NOGINS
- Status last verified
- Mar 2022
- First submitted
- 29 Sep 2020
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurodevelopmental Outcomes and Growth in Infants With Congenital Gastrointestinal Anomalies Requiring Neonatal Surgery
- ClinicalTrials.gov ID
- NCT04575649
- Acronym / sponsor ID
- NOGINS / 1910-132
- Conditions
- Gastrointestinal Disease
- Keywords
- Body composition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Children's Hospitals and Clinics of MinnesotaUniversity, hospital or other
- Collaborators
- University of Minnesota
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 days to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastrointestinal anomaliesInfants 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. | Other | – |
Primary outcome
Growth
Time frame: At term equivalence and at 4 months corrected age
Anthropometric and body composition measurements
1 secondary outcome
Neurodevelopment
Time frame: At 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin Plummer, MD principal investigator
Children's Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Disease, run by Children's Hospitals and Clinics of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erin Plummer, MD (651-220-6264, erin.plummer@childrensmn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth (time frame: At term equivalence and at 4 months corrected age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.