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22 October 2014 
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Effect of palivizumab on wheezing after respiratory syncytial virus (RSV) infection
DOI 10.1186/ISRCTN73641710
ClinicalTrials.gov identifier
EudraCT number
Public title Effect of palivizumab on wheezing after respiratory syncytial virus (RSV) infection
Scientific title Effect of palivizumab on respiratory syncytial virus-associated burden of disease: a randomised controlled trial [Effect van palivizumab op lange termijn gevolgen veroorzaakt door het respiratoir syncytieel virus: een gerandomiseerde placebo-gecontroleerd onderzoek]
Acronym MAKI
Serial number at source NTR1023
Study hypothesis It is not known whether recurrent wheeze in preterm children is caused by respiratory syncytial virus (RSV) infection (serial hypothesis) or that RSV infection is the first indication of chronic airway morbidity that would develop anyway (parallel hypothesis). This study aims to distinguish between these two hypotheses by investigating whether prevention of RSV (by palivizumab) results in decreased incidence of recurrent wheeze.

On 27/06/2014 the following changes were made to the trial record:
1. The study design was changed from 'Double-blind randomised placebo-controlled multicentre trial' to 'Double-blind randomised placebo-controlled multicentre trial with single-blind follow-up study 6 years hereafter'
2. The anticipated end date was changed from 01/04/2011 to 01/04/2017.
Lay summary Not provided at time of registration
Ethics approval Medisch Ethische Toetsingscommissie (METC) of the Universitair Medisch Centrum Utrecht, 21/07/2008
Study design Double-blind randomised placebo-controlled multicentre trial with single-blind follow-up study 6 years hereafter
Countries of recruitment Netherlands
Disease/condition/study domain Respiratory syncytial virus bronchiolitis and post-bronchiolitis wheezing
Participants - inclusion criteria 1. Healthy preterm infants
2. Gestational age between 32 and 35 weeks, either sex
3. Children of parents who master the Dutch language
Participants - exclusion criteria 1. A known cardiac anomaly, Down's syndrome or other serious congenital disorders
2. Require intensive respiratory treatment, defined as surfactant treatment or at least 2 weeks of mechanical ventilation
3. Greater than 6 months of age at the start of the RSV season, defined as 1st October of the year of birth
4. Airway morbidity before the start of the RSV season, monitored before the first injection
Anticipated start date 01/08/2008
Anticipated end date 01/04/2017
Status of trial Ongoing
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 452
Interventions Infants will receive one-monthly intramuscular palivizumab 15 mg/kg or placebo from discharge until the end of the RSV season with a maximum of five injections.
Primary outcome measure(s) Number of wheezing days during the first year of life.
Secondary outcome measure(s) 1. Questionnaire-reported wheezing, health-related quality of life and health-economic consequences of RSV at age 1, 3 and 6 years
2. Nasopharyngeal swabs for viral analysis during the RSV season in case of a runny nose or mild cough. These samples will be tested for viruses, to determine if the child is infected with RSV and/or other viruses. It is emphasised that RSV infection is not part of the endpoint of this study.

Added 27/06/2014:
3. Lung function at age 6 years
4. Questionnaire-reported asthma-related respiratory symptoms (ISAAC questionnaire) at age 6 years
Sources of funding Abbott International plc (UK) - no restrictions for publication of the research data
Trial website
Publications 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23656644
Contact name Dr  Louis  Bont
  Address Lundlaan 6
  City/town Utrecht
  Zip/Postcode 3584 EA
  Country Netherlands
  Email l.j.bont@umcutrecht.nl
Sponsor University Medical Centre Utrecht (UMCU) (Netherlands)
  Address c/o Prof. dr. E.A.M Sanders
Lundlaan 6
  City/town Utrecht
  Zip/Postcode 3584 EA
  Country Netherlands
  Sponsor website: http://www.umcutrecht.nl
Date applied 21/11/2008
Last edited 27/06/2014
Date ISRCTN assigned 23/01/2009
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