'The Impact of Rhinovirus Infections in Paediatric Cardiac Surgery'

NCT02438293 | Completed

• 1 other identifier: P14.303
• Study Type: observational
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective single- center observational study in the Leiden University Medical Center in 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 collected. Clinical data will be collected daily during paediatric intensive care admission, and date of discharge from paediatric intensive care unit and from hospital are 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 a polymerase chain reaction. Main study parameter is the paediatric intensive care unit length of stay in per-operative rhinovirus -positive compared to rhinovirus-negative patients.

Conditions

Rhinovirus; Congenital Heart Disease; Respiratory Infections; Post-operative Complications

Keywords

rhinovirus; cardiac surgery; paediatric; respiratory infection; children

Outcome Measures

Primary Outcomes (1)

• post-operative PICU length of stay

  rhinovirus PCR positive compared to rhinovirus negative patients

  participants will be followed for the duration of PICU stay, an expected average of 3,8 days

Secondary Outcomes (11)

• Duration of ventilatory support

  participants will be followed for the duration of PICU stay, an expected average of 3,8 days

• mean airway pressure

  participants will be followed for the duration of PICU stay, an expected average of 3,8 days

• FiO2

  participants will be followed for the duration of PICU stay, an expected average of 3,8 days

• peak inspiratory pressure (maximum values)

  participants will be followed for the duration of PICU stay, an expected average of 3,8 days

• positive end expiratory pressure (maximum values)

  participants will be followed for the duration of PICU stay, an expected average of 3,8 days

Study Arms (1)

children undergoing cardiac surgery

paediatric patients with a congenital heart disease undergoing elective cardiac surgery

Other: rhinovirus diagnostics

Interventions

rhinovirus diagnostics OTHER

rhinovirus PCR on a nasopharyngeal swab

children undergoing cardiac surgery

Eligibility Criteria

• Age: Up to 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children (\<12 year) with a congenital heart disease undergoing elective cardiac surgery

You may qualify if:

• Children (\<12 year) with a congenital heart disease undergoing elective cardiac surgery
• Written informed consent by parents or guardian

You may not qualify if:

• No informed consent from one of the parents (or the legal representative if applicable)
• Anaesthesiologist or cardiopulmonary surgeon postpones surgery based on routine hospital screening
• Emergency surgery
• Pre-operative admission to the neonatology department
• Children not admitted to the intensive care unit after cardiac surgery
• Children undergoing a second cardiac operation during the same intensive care stay
• Children with duct-dependent physiology who remain prostaglandin-dependent after the heart operation (they will be excluded because they will certainly have a prolonged PICU LOS regardless of a possible rhinovirus infection). For example: hypoplastic left heart syndrome following pulmonary artery banding who will remain on prostaglandins until the next staged operation

Sponsors & Collaborators

• Leiden University: lead

Study Sites (1)

Leiden University Medical Center

Leiden, Netherlands

Location

Related Publications (1)

• Roeleveld PP, Van Rijn AL, de Wilde RBP, van Zwet EW, Wink J, Rozendaal L, Hogenbirk K, Hazekamp MG, Man WH, Sidorov I, Kraakman MEM, Claas ECJ, de Jonge E, Kroes ACM, de Vries JJC. Rhinovirus Detection in the Nasopharynx of Children Undergoing Cardiac Surgery Is Not Associated With Longer PICU Length of Stay: Results of the Impact of Rhinovirus Infection After Cardiac Surgery in Kids (RISK) Study. Pediatr Crit Care Med. 2021 Jan 1;22(1):e79-e90. doi: 10.1097/PCC.0000000000002522.

  PMID: 33027243 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

nasopharyngeal swabs serum EDTA plasma

MeSH Terms

Conditions

Heart Defects, Congenital; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infections; Respiratory Tract Diseases

Study Officials

• Anneloes L Klink, Msc

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. PhD

Study Record Dates

• First Submitted: April 30, 2015
• First Posted: May 8, 2015
• Study Start: June 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: September 25, 2020

Record last verified: 2020-09

Locations

NL (1)