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

This study has been completed.
Sponsor:
Collaborator:
Assign Data Management and Biostatistics GmbH
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01077271
First received: February 25, 2010
Last updated: August 20, 2012
Last verified: August 2012
  Purpose

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.


Condition
Premature Infants

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Number of Injections Per Patient Per Season [ Time Frame: One RSV season (5 months) ] [ Designated as safety issue: No ]
    The average number of injections administered per participant within a respiratory syncytial virus season.

  • Body Site of Injections Per Administration [ Time Frame: One RSV season (5 months) ] [ Designated as safety issue: No ]
    The body site of injection administration for participants at each study visit.

  • Interval Between Administrations [ Time Frame: One RSV season (5 months) ] [ Designated as safety issue: No ]
    The average number of days that elapsed between palivizumab injections administered at the previous study visit.

  • Dosage Per Administration [ Time Frame: One RSV season (5 months) ] [ Designated as safety issue: No ]
    The median dose and range of palivizumab (milligrams) that was administered at each study visit.


Secondary Outcome Measures:
  • Assessment of Pain During Injection According to Pain Scores (VAS and Modified Behavioral Pain Scale) [ Time Frame: One RSV season (5 months) ] [ Designated as safety issue: No ]
    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.

  • Parents Knowledge of Burden of RSV Disease Via Interview by Physician [ Time Frame: One RSV season (5 months) ] [ Designated as safety issue: No ]
    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.

  • Effectiveness of Palivizumab at the End of the Observation Period is Checked by the Physician by Ranking in a Visible Analog Scale [ Time Frame: One RSV season (5 months), end of study ] [ Designated as safety issue: No ]
    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.


Enrollment: 124
Study Start Date: October 2008
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Premature infants 33 - 35 wGA prophylaxed with palivizumab
Premature infants 33 - 35 weeks gestational age (wGA) prophylaxed with Synagis (palivizumab)

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Medical practices specialized in pediatrics.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01077271

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

Additional Information:
No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01077271     History of Changes
Other Study ID Numbers: P11-040
Study First Received: February 25, 2010
Results First Received: May 17, 2012
Last Updated: August 20, 2012
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by Abbott:
Premature infants
Respiratory Syncytial Virus (RSV)
Compliance
Palivizumab

Additional relevant MeSH terms:
Palivizumab
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014