Status:
COMPLETED
Monitor Faecal Calprotectin Concentration in Infants With Heart Defects
Lead Sponsor:
Great Ormond Street Hospital for Children NHS Foundation Trust
Conditions:
Calprotectin
Cyanotic Heart Disease
Eligibility:
All Genders
1-1 years
Brief Summary
Infants born with heart problems are at risk of developing gut disease due to reduced blood flow to the intestines which can result in poor weight gain, surgery and even death. At present, doctors are...
Detailed Description
Background: Congenital heart disease is the most common birth defect in the U.K., affecting between 0.3-1.5% (9 in every 1000 live births) of infants (Hoffman and Kaplan 2002), and requires immediate...
Eligibility Criteria
Inclusion
- \- Term infants (\>37 weeks gestation) delivered vaginally (bacterial colonisation)
- Birth weight \> 2.0kg (low birth weight classification)
- High risk infants - cyanotic heart defect (univentricular heart - hypoplastic left heart syndrome and hypoplastic right heart, or truncus arteriosus or coarctation of Great arteries).
Exclusion
- Any gastroenterological complications such as gastro schisis
- Mother or infant received antibiotics 2 weeks prior to delivery
Key Trial Info
Start Date :
May 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03255564
Start Date
May 1 2018
End Date
June 30 2021
Last Update
February 9 2022
Active Locations (1)
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1
Great Ormond Street Hospital
London, United Kingdom, W1CN