faecal calprotectin levels in infants with heart defects Version 3
Research type
Research Study
Full title
A study to monitor faecal calprotectin levels in infants with heart defects
IRAS ID
224542
Contact name
Graeme O'Connor
Contact email
Sponsor organisation
Great Ormond Street Hospital
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
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 surgical intervention. Infants with heart defects are known to exhibit early and progressive falls in their growth trajectory compared to healthy infants, increasing risk of death post-surgery (Eskedal, Hagemo et al. 2008). Lifesaving cardiac surgery and feeding can increase the infant’s risk of developing gut inflammation and necrotising enterocolitis (NEC). NEC is a severe gastrointestinal disorder associated with high morbidity and mortality (Kelleher, Laussen et al. 2006).
In preterm infants, faecal calprotectin is used to diagnose NEC and has the potential to identify high risk infants earlier than current practice. Calprotectin levels have not been monitored in infants with heart defects and have the potential to be used to predict and diagnose NEC eliminating the need for abdominal radiography (radiation.
The aetiology of NEC in preterm infants is different to that of infants with cardiac defects and therefore warrants an independent study. Furthermore, an earlier diagnosis of NEC than that of current practice has the potential to reduce the long-term complications associated with gut damage and reduce the length of time on parenteral nutrition and ultimately time on intensive care – improving overall patient care.
The aim of the study is to validate whether faecal calprotectin can be used as useful non-invasive marker to diagnose and predict NEC in infants with cardiac defects.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
17/YH/0446
Date of REC Opinion
5 Jan 2018
REC opinion
Further Information Favourable Opinion