N/A
N=124
Compliance to Synagis (Palivizumab) Under Daily Pediatrician´s Conditions in Premature Infants 33 - 35 wGA
Premature Infants
Bottom Line
View on ClinicalTrials.gov: NCT01077271 ↗Enrolled (actual)
124
Serious AEs
4.2%
Results posted
Aug 2012
Primary outcome: Primary: Number of Injections Per Patient Per Season — 3.8; 3.9; 4.0; 1.0 Injections administered
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric
- Sex
- All
- Sponsor
- Abbott
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Injections Per Patient Per Season |
3.8; 3.9; 4.0; 1.0; 3.8 | — |
| PRIMARY Body Site of Injections Per Administration |
38; 44; 29; 4; 115; 34 | — |
| PRIMARY Interval Between Administrations |
28.5; 30.6; 28.6; NA; 29.4; 33.2 | — |
| PRIMARY Dosage Per Administration |
60.0; 50.0; 73.5; 52.5; 60.0; 77.5 | — |
| SECONDARY Assessment of Pain During Injection According to Pain Scores (VAS and Modified Behavioral Pain Scale) |
50.2; 64.1; 53.5; 62.5; 57.0; 7.2 | — |
| SECONDARY Parents Knowledge of Burden of RSV Disease Via Interview by Physician |
39; 36; 31; 4; 110; 28 | — |
| SECONDARY Effectiveness of Palivizumab at the End of the Observation Period is Checked by the Physician by Ranking in a Visible Analog Scale |
9.9; 9.8; 9.9; 10.0; 9.9; 10.0 | — |
Summary
Compliance to Synagis (palivizumab) is a key factor to obtain maximal protection against respiratory syncytial virus (RSV) infection as shown in the IMpact study. Many factors such as parents' knowledge of burden of respiratory syncytial virus disease or physicians' satisfaction with Synagis as well as the appropriate use of the product might influence compliance. The primary objective of this observational study is to evaluate the compliance to Synagis under daily pediatricians practice conditions in premature infants 33 to 35 weeks gestational age (wGA). Palivizumab, monoclonal antibody for passive immunoprophylaxis against severe respiratory syncytial virus disease, was administered according to usual clinical practice. Compliance was assessed using four criteria: The number of injections per participant per respiratory syncytial virus season, the body site where injections were administered, the interval in days between injections, and the dosage per administration. Originally the study was to include two respiratory syncytial virus seasons but was extended to a third season.
Eligibility Criteria
Inclusion Criteria
- Premature infant 33 to 35 weeks gestational age
- Younger than 3 months at respiratory syncytial virus season start
- At least 4 points according to the Austrian risk score according to Austrian guidelines: 1 point younger than 3 months (at start of respiratory syncytial virus season), 1 point neurologic disease, 1 point weight less than 10th percentile, 1 point discharge from hospital during respiratory syncytial virus season (1 Oct - 30 March), 1 point older siblings, 0.5 points multiple births, 0.5 points day care attendance, 0.5 points passive tobacco smoke exposure, 0.5 points socio-economic status (overcrowding)
- Synagis application (prescription)
- Signed authorization form for data use (parental authorization)
Exclusion Criteria
- Patients without Synagis prescription
- Patients who meet contraindications as outlined in the latest version of Synagis summary of product characteristics (SmPC):
- Patients with known hypersensitivity to palivizumab or any component of the formulation or other humanized monoclonal antibodies
- Patients with chronic lung disease
- Patients with congenital heart disease
- Greater than 36 weeks gestational age
Data sourced from ClinicalTrials.gov (NCT01077271). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.