Clinical trial NCT01077271: Compliance to Synagis (Palivizumab) Under Daily Pediatrician´s Conditions in Premature Infants 33 - 35 wGA
Official title: PMOS to Evaluate the Compliance to Synagis (Palivizumab) Under Daily Pediatrician´s Conditions in Premature Infants 33 - 35 wGA Over 3 Consecutive Respiratory Syncytial Virus (RSV) Seasons in Austria
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Infants
Keywords: Premature infants
Respiratory Syncytial Virus (RSV)
Compliance
Palivizumab
Lead sponsor: Abbott
Sponsor class: INDUSTRY
Collaborators: name: Assign Data Management and Biostatistics GmbH
First posted: 2010-03-01
Enrollment: 124
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medical practices specialized in pediatrics.

Brief 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

Primary outcomes:
measure: Number of Injections Per Patient Per Season
timeFrame: One RSV season (5 months)
measure: Body Site of Injections Per Administration
timeFrame: One RSV season (5 months)
measure: Interval Between Administrations
timeFrame: One RSV season (5 months)
measure: Dosage Per Administration
timeFrame: One RSV season (5 months)
Secondary outcomes:
measure: Assessment of Pain During Injection According to Pain Scores (VAS and Modified Behavioral Pain Scale)
timeFrame: One RSV season (5 months)
measure: Parents Knowledge of Burden of RSV Disease Via Interview by Physician
timeFrame: One RSV season (5 months)
measure: Effectiveness of Palivizumab at the End of the Observation Period is Checked by the Physician by Ranking in a Visible Analog Scale
timeFrame: One RSV season (5 months), end of study
Other outcomes:
Locations:
city: Amstetten
country: Austria
facility: Site Reference ID/Investigator# 27772
city: Amstetten
country: Austria
facility: Site Reference ID/Investigator# 52871
city: Feldkirch
country: Austria
facility: Site Reference ID/Investigator# 52873
city: Ganserndorf
country: Austria
facility: Site Reference ID/Investigator# 40437
city: Hollabrunn
country: Austria
facility: Site Reference ID/Investigator# 30843
city: Judenburg
country: Austria
facility: Site Reference ID/Investigator# 27767
city: Klagenfurt
country: Austria
facility: Site Reference ID/Investigator# 27770
city: Klosterneuburg
country: Austria
facility: Site Reference ID/Investigator# 27777
city: Krems
country: Austria
facility: Site Reference ID/Investigator# 30842
city: Leonding
country: Austria
facility: Site Reference ID/Investigator# 27771
city: Linz
country: Austria
facility: Site Reference ID/Investigator# 52867
city: Linz
country: Austria
facility: Site Reference ID/Investigator# 58943
city: Linz
country: Austria
facility: Site Reference ID/Investigator# 18603
city: Linz
country: Austria
facility: Site Reference ID/Investigator# 40445
city: Linz
country: Austria
facility: Site Reference ID/Investigator# 52874
city: Mattersburg
country: Austria
facility: Site Reference ID/Investigator# 52870
city: Neufeld
country: Austria
facility: Site Reference ID/Investigator# 48262
city: Purkersdorf
country: Austria
facility: Site Reference ID/Investigator# 27775
city: Scheibbs
country: Austria
facility: Site Reference ID/Investigator# 27765
city: Schorfling
country: Austria
facility: Site Reference ID/Investigator# 40440
city: St Polten
country: Austria
facility: Site Reference ID/Investigator# 30850
city: Telfs
country: Austria
facility: Site Reference ID/Investigator# 27764
city: Traisen
country: Austria
facility: Site Reference ID/Investigator# 40439
city: Tulln
country: Austria
facility: Site Reference ID/Investigator# 30848
city: Tulln
country: Austria
facility: Site Reference ID/Investigator# 27776
city: Vienna
country: Austria
facility: Site Reference ID/Investigator# 30845
city: Vienna
country: Austria
facility: Site Reference ID/Investigator# 30849
city: Vienna
country: Austria
facility: Site Reference ID/Investigator# 40432
city: Vienna
country: Austria
facility: Site Reference ID/Investigator# 40447
city: Vienna
country: Austria
facility: Site Reference ID/Investigator# 27773
city: Vienna
country: Austria
facility: Site Reference ID/Investigator# 52879
city: Vienna
country: Austria
facility: Site Reference ID/Investigator# 27769
city: Vienna
country: Austria
facility: Site Reference ID/Investigator# 40446
city: Vienna
country: Austria
facility: Site Reference ID/Investigator# 52878
city: Vienna
country: Austria
facility: Site Reference ID/Investigator# 27774
city: Vienna
country: Austria
facility: Site Reference ID/Investigator# 27762
city: Vienna
country: Austria
facility: Site Reference ID/Investigator# 27763
city: Vienna
country: Austria
facility: Site Reference ID/Investigator# 40442
city: Vienna
country: Austria
facility: Site Reference ID/Investigator# 30851
city: Vienna
country: Austria
facility: Site Reference ID/Investigator# 58942
city: Vienna
country: Austria
facility: Site Reference ID/Investigator# 30846
city: Vienna
country: Austria
facility: Site Reference ID/Investigator# 30847
city: Vienna
country: Austria
facility: Site Reference ID/Investigator# 57793
city: Vienna
country: Austria
facility: Site Reference ID/Investigator# 30852
city: Vienna
country: Austria
facility: Site Reference ID/Investigator# 40425
Study officials:
affiliation: Abbott Austria
name: Astrid Dworan-Timler, MD
role: STUDY_DIRECTOR
References: