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

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

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.

Study Overview

• Status: Completed
• Conditions: Premature Infants

• Study Type: Observational
• Enrollment (Actual): 124

Contacts and Locations

Study Locations

• Austria
  • Amstetten, Austria, 3300
    • Site Reference ID/Investigator# 27772
  • Amstetten, Austria, 3300
    • Site Reference ID/Investigator# 52871
  • Feldkirch, Austria, 6800
    • Site Reference ID/Investigator# 52873
  • Ganserndorf, Austria, 2230
    • Site Reference ID/Investigator# 40437
  • Hollabrunn, Austria, 2020
    • Site Reference ID/Investigator# 30843
  • Judenburg, Austria, 8750
    • Site Reference ID/Investigator# 27767
  • Klagenfurt, Austria, 9020
    • Site Reference ID/Investigator# 27770
  • Klosterneuburg, Austria, 3400
    • Site Reference ID/Investigator# 27777
  • Krems, Austria, 3500
    • Site Reference ID/Investigator# 30842
  • Leonding, Austria, 4060
    • Site Reference ID/Investigator# 27771
  • Linz, Austria, 4020
    • Site Reference ID/Investigator# 52867
  • Linz, Austria, 4020
    • Site Reference ID/Investigator# 58943
  • Linz, Austria, 4030
    • Site Reference ID/Investigator# 18603
  • Linz, Austria, 4040
    • Site Reference ID/Investigator# 40445
  • Linz, Austria, 4040
    • Site Reference ID/Investigator# 52874
  • Mattersburg, Austria, 7210
    • Site Reference ID/Investigator# 52870
  • Neufeld, Austria, 2491
    • Site Reference ID/Investigator# 48262
  • Purkersdorf, Austria, 3002
    • Site Reference ID/Investigator# 27775
  • Scheibbs, Austria, 3270
    • Site Reference ID/Investigator# 27765
  • Schorfling, Austria, 4861
    • Site Reference ID/Investigator# 40440
  • St Polten, Austria, 3100
    • Site Reference ID/Investigator# 30850
  • Telfs, Austria, 6410
    • Site Reference ID/Investigator# 27764
  • Traisen, Austria, 3160
    • Site Reference ID/Investigator# 40439
  • Tulln, Austria, 3400
    • Site Reference ID/Investigator# 30848
  • Tulln, Austria, 3430
    • Site Reference ID/Investigator# 27776
  • Vienna, Austria, 1020
    • Site Reference ID/Investigator# 30845
  • Vienna, Austria, 1030
    • Site Reference ID/Investigator# 30849
  • Vienna, Austria, 1030
    • Site Reference ID/Investigator# 40432
  • Vienna, Austria, 1030
    • Site Reference ID/Investigator# 40447
  • Vienna, Austria, 1040
    • Site Reference ID/Investigator# 27773
  • Vienna, Austria, 1060
    • Site Reference ID/Investigator# 52879
  • Vienna, Austria, 1090
    • Site Reference ID/Investigator# 27769
  • Vienna, Austria, 1100
    • Site Reference ID/Investigator# 40446
  • Vienna, Austria, 1100
    • Site Reference ID/Investigator# 52878
  • Vienna, Austria, 1110
    • Site Reference ID/Investigator# 27774
  • Vienna, Austria, 1120
    • Site Reference ID/Investigator# 27762
  • Vienna, Austria, 1150
    • Site Reference ID/Investigator# 27763
  • Vienna, Austria, 1190
    • Site Reference ID/Investigator# 40442
  • Vienna, Austria, 1200
    • Site Reference ID/Investigator# 30851
  • Vienna, Austria, 1200
    • Site Reference ID/Investigator# 58942
  • Vienna, Austria, 1210
    • Site Reference ID/Investigator# 30846
  • Vienna, Austria, 1210
    • Site Reference ID/Investigator# 30847
  • Vienna, Austria, 1210
    • Site Reference ID/Investigator# 57793
  • Vienna, Austria, 1220
    • Site Reference ID/Investigator# 30852
  • Vienna, Austria, 1220
    • Site Reference ID/Investigator# 40425

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Medical practices specialized in pediatrics.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Premature infants 33 - 35 wGA prophylaxed with palivizumab; Premature infants 33 - 35 weeks gestational age (wGA) prophylaxed with Synagis (palivizumab)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Injections Per Patient Per Season	The average number of injections administered per participant within a respiratory syncytial virus season.	One RSV season (5 months)
Body Site of Injections Per Administration	The body site of injection administration for participants at each study visit.	One RSV season (5 months)
Interval Between Administrations	The average number of days that elapsed between palivizumab injections administered at the previous study visit.	One RSV season (5 months)
Dosage Per Administration	The median dose and range of palivizumab (milligrams) that was administered at each study visit.	One RSV season (5 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Pain During Injection According to Pain Scores (VAS and Modified Behavioral Pain Scale)	The clinician who administered the palivizumab injection was asked to rate pain during injection using a visual analog scale (VAS) and the Modified Behavior Pain Scale (MBPS) as published by Carbajal et al., 2008. The VAS ranged from 0 (no pain) to 100 (maximum pain). The Modified Behavioral Pain Scale ranged from 0 (no pain) to 10 (maximum pain) through the evaluation of 3 items: Facial expressions, cry, and movements. If more than one injection was given at a visit, then the first injection was rated.	One RSV season (5 months)
Parents Knowledge of Burden of RSV Disease Via Interview by Physician	An informational brochure was given to parents of participants. Parents were interviewed by the treating physician at the first study visit (V1) and last study visit (LSV) (or early termination visit [ET]) for those participants discontinuing from the study). Parental knowledge of the burden of respiratory syncytial virus (RSV) disease was assessed using a questionnaire. Parents were considered to have "good RSV awareness" if all questions were answered and at least 3 of the 4 questions regarding the burden of RSV disease were answered correctly.	One RSV season (5 months)
Effectiveness of Palivizumab at the End of the Observation Period is Checked by the Physician by Ranking in a Visible Analog Scale	The therapeutic effect of palivizumab was assessed by the treating physician using a visual analog scale from 0 to 10, where 0 indicated that palivizumab did not match expectations at all and 10 indicated that palivizumab met all expectations. The physician rated palivizumab treatment for each participant at the last study visit (LSV) or, in the case of participants withdrawing from the study, at the early termination (ET) visit.	One RSV season (5 months), end of study

Collaborators and Investigators

• Sponsor: Abbott
• Collaborators: Assign Data Management and Biostatistics GmbH
• Investigators: Study Director: Astrid Dworan-Timler, MD, Abbott Austria

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: February 25, 2010
• First Submitted That Met QC Criteria: February 25, 2010
• First Posted (Estimate): March 1, 2010

Study Record Updates

• Last Update Posted (Estimate): August 21, 2012
• Last Update Submitted That Met QC Criteria: August 20, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Premature infants; Respiratory Syncytial Virus (RSV); Compliance; Palivizumab
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: P11-040

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No