Condition category
Respiratory
Date applied
21/11/2008
Date assigned
23/01/2009
Last edited
27/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Louis Bont

ORCID ID

Contact details

Lundlaan 6
Utrecht
3584 EA
Netherlands
l.j.bont@umcutrecht.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR1023

Study information

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

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.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Respiratory syncytial virus bronchiolitis and post-bronchiolitis wheezing

Intervention

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.

Intervention type

Drug

Phase

Not Applicable

Drug names

Palivizumab

Primary outcome measures

Number of wheezing days during the first year of life.

Secondary outcome measures

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

Overall trial start date

01/08/2008

Overall trial end date

01/04/2017

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

452

Participant 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

Recruitment start date

01/08/2008

Recruitment end date

01/04/2017

Locations

Countries of recruitment

Netherlands

Trial participating centre

Lundlaan 6
Utrecht
3584 EA
Netherlands

Sponsor information

Organisation

University Medical Centre Utrecht (UMCU) (Netherlands)

Sponsor details

c/o Prof. dr. E.A.M Sanders
Lundlaan 6
Utrecht
3584 EA
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.umcutrecht.nl

Funders

Funder type

Industry

Funder name

Abbott International plc (UK) - no restrictions for publication of the research data

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23656644

Publication citations

  1. Results

    Blanken MO, Rovers MM, Molenaar JM, Winkler-Seinstra PL, Meijer A, Kimpen JL, Bont L, , Respiratory syncytial virus and recurrent wheeze in healthy preterm infants., N. Engl. J. Med., 2013, 368, 19, 1791-1799, doi: 10.1056/NEJMoa1211917.

Additional files

Editorial Notes