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Compliance to Synagis (Palivizumab) Under Daily Pediatrician´s Conditions in Premature Infants 33 - 35 wGA

NCT ID: NCT01077271

Last Updated: 2012-08-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

124 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Premature Infants

Keywords

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Premature infants Respiratory Syncytial Virus (RSV) Compliance Palivizumab

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Premature infants 33 - 35 wGA prophylaxed with palivizumab

Premature infants 33 - 35 weeks gestational age (wGA) prophylaxed with Synagis (palivizumab)

No interventions assigned to this group

Eligibility Criteria

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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
Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assign Data Management and Biostatistics GmbH

OTHER

Sponsor Role collaborator

Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Astrid Dworan-Timler, MD

Role: STUDY_DIRECTOR

Abbott Austria

Locations

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Site Reference ID/Investigator# 27772

Amstetten, , Austria

Site Status

Site Reference ID/Investigator# 52871

Amstetten, , Austria

Site Status

Site Reference ID/Investigator# 52873

Feldkirch, , Austria

Site Status

Site Reference ID/Investigator# 40437

Gänserndorf, , Austria

Site Status

Site Reference ID/Investigator# 30843

Hollabrunn, , Austria

Site Status

Site Reference ID/Investigator# 27767

Judenburg, , Austria

Site Status

Site Reference ID/Investigator# 27770

Klagenfurt, , Austria

Site Status

Site Reference ID/Investigator# 27777

Klosterneuburg, , Austria

Site Status

Site Reference ID/Investigator# 30842

Krems, , Austria

Site Status

Site Reference ID/Investigator# 27771

Leonding, , Austria

Site Status

Site Reference ID/Investigator# 52867

Linz, , Austria

Site Status

Site Reference ID/Investigator# 58943

Linz, , Austria

Site Status

Site Reference ID/Investigator# 18603

Linz, , Austria

Site Status

Site Reference ID/Investigator# 40445

Linz, , Austria

Site Status

Site Reference ID/Investigator# 52874

Linz, , Austria

Site Status

Site Reference ID/Investigator# 52870

Mattersburg, , Austria

Site Status

Site Reference ID/Investigator# 48262

Neufeld, , Austria

Site Status

Site Reference ID/Investigator# 27775

Purkersdorf, , Austria

Site Status

Site Reference ID/Investigator# 30850

Sankt Pölten, , Austria

Site Status

Site Reference ID/Investigator# 27765

Scheibbs, , Austria

Site Status

Site Reference ID/Investigator# 40440

Schörfling, , Austria

Site Status

Site Reference ID/Investigator# 27764

Telfs, , Austria

Site Status

Site Reference ID/Investigator# 40439

Traisen, , Austria

Site Status

Site Reference ID/Investigator# 30848

Tulln, , Austria

Site Status

Site Reference ID/Investigator# 27776

Tulln, , Austria

Site Status

Site Reference ID/Investigator# 30845

Vienna, , Austria

Site Status

Site Reference ID/Investigator# 30849

Vienna, , Austria

Site Status

Site Reference ID/Investigator# 40432

Vienna, , Austria

Site Status

Site Reference ID/Investigator# 40447

Vienna, , Austria

Site Status

Site Reference ID/Investigator# 27773

Vienna, , Austria

Site Status

Site Reference ID/Investigator# 52879

Vienna, , Austria

Site Status

Site Reference ID/Investigator# 27769

Vienna, , Austria

Site Status

Site Reference ID/Investigator# 40446

Vienna, , Austria

Site Status

Site Reference ID/Investigator# 52878

Vienna, , Austria

Site Status

Site Reference ID/Investigator# 27774

Vienna, , Austria

Site Status

Site Reference ID/Investigator# 27762

Vienna, , Austria

Site Status

Site Reference ID/Investigator# 27763

Vienna, , Austria

Site Status

Site Reference ID/Investigator# 40442

Vienna, , Austria

Site Status

Site Reference ID/Investigator# 30851

Vienna, , Austria

Site Status

Site Reference ID/Investigator# 58942

Vienna, , Austria

Site Status

Site Reference ID/Investigator# 30846

Vienna, , Austria

Site Status

Site Reference ID/Investigator# 30847

Vienna, , Austria

Site Status

Site Reference ID/Investigator# 57793

Vienna, , Austria

Site Status

Site Reference ID/Investigator# 30852

Vienna, , Austria

Site Status

Site Reference ID/Investigator# 40425

Vienna, , Austria

Site Status

Countries

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Austria

Related Links

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http://dailymed.nlm.nih.gov/dailymed/about.cfm

Related Info

Other Identifiers

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P11-040

Identifier Type: -

Identifier Source: org_study_id