|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT01107535 |
|
Date of registration:
|
20/02/2010 |
|
Primary sponsor: |
|
|
Public title:
|
Effectiveness of Synagis (Palivizumab) Immunoprophylaxis in Preterm Infants With High Risk of Severe Respiratory Syncytial Virus (RSV) Infection
INSPIRA |
|
Scientific title:
|
Observational Study of the Effectiveness of Synagis Immunoprophylaxis in Preterm Infants With High Risk of Severe Respiratory Syncytial Virus Infection |
|
Date of first enrolment:
|
September 2007 |
|
Target sample size:
|
82 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT01107535 |
|
Study type:
|
Observational |
|
Study design:
|
Observational Model: Cohort, Time Perspective: Prospective
|
|
|
Countries of recruitment
|
|
Peru
| | | | | | | |
|
Contacts
|
|
Name:
|
Oscar Guerra, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Abbott |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Receiving Synagis (palivizumab) immunoprophylaxis during respiratory syncytial virus
season, according to the usual clinical practice:
- Infants born < or = 32 weeks of gestation and are younger than 6 months of age at the
beginning of the respiratory syncytial virus season.
- Children with bronchopulmonary dysplasia who have received medical treatment in the
last 6 months, until the first year of life.
- Children 12 months or younger with hemodynamically significant acyanotic congenital
heart disease (pulmonary hypertension or heart failure in treatment).
Exclusion Criteria:
- Major congenital malformation aside from congenital heart disease
- Chronic pulmonary disease other than bronchopulmonary dysplasia
- Active infections
- Contraindication to Synagis
- Receipt of another immunoglobulin preparation including but not restricted to
polyclonal intravenous immunoglobulin, cytomegalovirus hyperimmunoglobulin (Cytogam),
or respiratory syncytial virus hyperimmunoglobulin (Respigam).
- Any other condition that according deemed an obstacle for study conduction or
representing an unacceptable risk by the participating investigator.
Age minimum:
N/A
Age maximum:
6 Months
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Respiratory Syncytial Virus Infection
|
|
Intervention(s)
|
|
Biological: Synagis (palivizumab), monoclonal antibody for passive immunoprophylaxis against severe RSV disease administered according to usual clinical practice.
|
|
Primary Outcome(s)
|
|
Number of Hospital Admissions by Respiratory Syncytial Virus Infection
[Time Frame: First year of life (up to 12 months)]
|
|
Secondary Outcome(s)
|
|
Number of Hospital Admission Days (All Causes)
[Time Frame: Hospital admission to hospital discharge]
|
|
Number of Intensive Care Unit Days During the Hospital Admissions by Respiratory Syncytial Virus Infection
[Time Frame: Hospital admission to hospital discharge]
|
|
Number of Serious Adverse Events
[Time Frame: Enrollment until 100 days after the last Synagis (palivizumab) dose]
|
|
Number of Ventilation Support Days (Supplemental Oxygen and Mechanical Ventilation) During the Hospital Admission
[Time Frame: Hospital admission to hospital discharge]
|
|
Secondary ID(s)
|
|
PMOS-PERU-07-01
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|