Monitor Faecal Calprotectin Concentration in Infants With Heart Defects

NCT03255564 | Completed DMC

• 1 other identifier: 16ht03
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (1)

• Necrotising enterocolitis

  Bell's stage 1-6

  1 month

Interventions

feacal calprotectin concentration OTHER

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.

Eligibility Criteria

• Age: 1 Day - 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

This study will be performed at Great Ormond Street Children's Hospital NHS Foundation Trust on the cardiac intensive care unit.

You may qualify if:

• \- 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).

You may not qualify if:

• Any gastroenterological complications such as gastro schisis
• Mother or infant received antibiotics 2 weeks prior to delivery

Sponsors & Collaborators

• Great Ormond Street Hospital for Children NHS Foundation Trust: lead

Study Sites (1)

Great Ormond Street Hospital

London, W1CN, United Kingdom

Location

Related Publications (1)

• O'Connor G, Brown KL, Taylor AM. Faecal calprotectin concentrations in neonates with CHD: pilot study. Cardiol Young. 2020 May;30(5):624-628. doi: 10.1017/S1047951120000645. Epub 2020 Apr 3.

  PMID: 32241322 RESULT

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2017
• First Posted: August 21, 2017
• Study Start: May 1, 2018
• Primary Completion: September 30, 2020
• Study Completion: June 30, 2021
• Last Updated: February 9, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)