Journal of Clinical Trials

Journal of Clinical Trials
Open Access

ISSN: 2167-0870

+44 7868 792050


The Impact of Rhinovirus Infections in Paediatric Cardiac Surgery (Risk): Study Protocol for a Prospective Cohort Study

Anneloes L van Rijn, Peter P Roeleveld, Rob BP de Wilde, Erik W van Zwet, Mark G Hazekamp, Jeroen Wink, Job CJ Calis, Alois CM Kroes and Jutte JC de Vries

Background: Respiratory infections are considered a potential risk of adverse events in children undergoing surgery. Rhinovirus is a common cause of respiratory infections and congenital heart disease is a risk factor for severe rhinovirus infection. However, we do not know what the impact of, clinical or subclinical, rhinovirus infections is on postoperative course following congenital heart surgery in children.
Based on our clinical experience, one case-controlled study, and a case reported in the literature, we hypothesize that paediatric patients with per-operative rhinovirus positive Polymerase Chain Reaction testing have a longer paediatric intensive care unit admission, compared to children who test negative.
Methods/Design: This is a prospective single-center observational study in the Leiden University Medical Center with approximately 250 children (<12 years) undergoing elective cardiac surgery, for congenital heart disease.
The parents/guardians of the children will be asked to fill out a questionnaire, to asses respiratory symptoms in the last weeks, before the operation of their child. In the operating theatre, a nasopharyngeal swab will be collected. Clinical data will be collected daily during paediatric intensive care admission and paediatric intensive care unit and hospital length of stay will be recorded. If children are still intubated at day 4, a second nasopharyngeal swab and residual blood will be collected. The samples will be tested for rhinovirus with polymerase chain reaction. Primary outcome is the paediatric intensive care unit length of stay in per-operative rhinovirus-positive compared to rhinovirus-negative patients.
Discussion: This is the first study to screen children for rhinovirus before undergoing cardiac surgery and to study the effects on paediatric intensive care unit length of stay. Furthermore, we aim to identify children at risk for prolonged paediatric intensive care admission after cardiac surgery.