Effect of palivizumab on wheezing after respiratory syncytial virus (RSV) infection
| ISRCTN | ISRCTN73641710 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73641710 |
| Protocol serial number | NTR1023 |
| Sponsor | University Medical Centre Utrecht (UMCU) (Netherlands) |
| Funder | Abbott International plc (UK) - no restrictions for publication of the research data |
- Submission date
- 21/11/2008
- Registration date
- 23/01/2009
- Last edited
- 24/03/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Respiratory syncytial virus (RSV) is a very common virus that leads to mild, cold-like symptoms in adults and older healthy children. It is not known whether recurrent wheezing in preterm children is caused by RSV infection, or whether RSV infection is just the first indication of chronic airway disease that would develop anyway. This study aims to find out by investigating whether prevention of RSV using the drug palivizumab results in a decreased incidence of recurrent wheeze.
Who can participate?
Healthy preterm infants (gestational age between 32 and 35 weeks)
What does the study involve?
Infants are randomly allocated to receive one-monthly intramuscular injections (into a muscle) of either palivizumab or a placebo (dummy) drug from discharge until the end of the RSV season, with a maximum of five injections. Number of wheezing days are recorded during the first year of life, and questionnaires are completed at age 1, 3 and 6 years. Throat swabs are taken for viral analysis during the RSV season in case of a runny nose or mild cough. These samples are tested for viruses, to determine whether the child is infected with RSV and/or other viruses. Lung function is tested and asthma-related breathing symptoms are measured by questionnaire at age 6 years.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
University Medical Centre Utrecht (UMCU) (Netherlands)
When is the study starting and how long is it expected to run for?
August 2008 to April 2017
Who is funding the study?
Abbott International plc (UK)
Who is the main contact?
Dr Louis Bont
l.j.bont@umcutrecht.nl
Contact information
Scientific
Lundlaan 6
Utrecht
3584 EA
Netherlands
| l.j.bont@umcutrecht.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind randomised placebo-controlled multicentre trial with single-blind follow-up study 6 years hereafter |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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] |
| Study acronym | MAKI |
| Study objectives | 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. |
| Ethics approval(s) | Medisch Ethische Toetsingscommissie (METC) of the Universitair Medisch Centrum Utrecht, 21/07/2008 |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Palivizumab |
| Primary outcome measure(s) |
Number of wheezing days during the first year of life |
| Key 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 |
| Completion date | 01/04/2017 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Child |
| Sex | All |
| Target sample size at registration | 452 |
| Total final enrolment | 429 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/08/2008 |
| Date of final enrolment | 01/04/2017 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
3584 EA
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 09/05/2013 | Yes | No | |
| Results article | results | 01/04/2018 | Yes | No | |
| Results article | results | 01/10/2020 | 24/03/2020 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
24/03/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
08/03/2018: Publication reference added.
11/03/2016: Plain English summary added.
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 overall trial end date was changed from 01/04/2011 to 01/04/2017.
