Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:17 PM
Ignite Modification Date:
2025-12-24 @ 10:17 PM
NCT ID:
NCT01107535
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
6 Months
Study:
NCT01107535
Study Brief:
Protocol Section:
NCT01107535