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Monitor Faecal Calprotectin Concentration in Infants With Heart Defects

NCT03255564 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2022-02-09

No results posted yet for this study

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 often unaware of any gut problems until clinical symptoms present (poor feed tolerance, blood stained stools or bloated stomach) which is often too late to prevent gut damage.

Earlier diagnosis of gut disease may now be possible; calprotectin is produced when the gut is inflamed and can be found in faeces and blood. Calprotectin levels have been shown to be a reliable marker in diagnosing gut disease in premature infants. To date, calprotectin levels have not been monitored in infants with cardiac defects, who like premature infants are at high risk of gut disease but the cause of gut disease is different to that seen in premature infants and therefore requires specific monitoring.

This study will implement a high risk feeding protocol which has been adapted from current feeding practices from the United States; the aim being to promote weight gain without increasing the risk of gut inflammation. Furthermore, the study will validate whether faecal calprotectin is a useful non-invasive marker in identifying gut disease in infants with cardiac defects. Currently, infants are diagnosed with necrotising enterocolitis by an abdominal X-ray (current 'Gold Standard'); infants who have a positive diagnosis will have faecal calprotectin levels cross-checked. From this data, cut-off values will be established which will provide data to diagnose necrotising enterocolitis eliminating the need for X-rays (radiation).

Secondly, faecal calprotectin levels will be measured at strategic time points (longitudinal data) linked to increased risk of gut damage (following cardiac surgery and feeding) which will then be cross-checked against infants that developed NEC to identify whether high risk infants had raised calprotectin levels earlier.

Conditions

  • Calprotectin
  • Cyanotic Heart Disease

Interventions

OTHER

feacal calprotectin concentration

Intervention - To monitor the impact of cardiac surgery and enteral feeding on gut inflammation, biomarkers (faecal Calprotectin) will be measured 24-48hrs after surgery and 24-48hrs after enteral feed commences. Additionally, infants that are diagnosed with NEC will have calprotectin levels measured. Faecal calprotectin - 50-100mg of faeces will be collected in plastic containers from infant's nappies. Samples will then be homogenised by shaking, and supernatants and then sent to laboratories for immediate analysis.

Sponsors & Collaborators

  • Great Ormond Street Hospital for Children NHS Foundation Trust

    lead OTHER

Eligibility

Min Age
1 Day
Max Age
1 Month
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2020-09-30
Completion
2021-06-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03255564 on ClinicalTrials.gov