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

February 25, 2010
August 20, 2012
October 2008
May 2011   (final data collection date for primary outcome measure)
  • 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.
Assessment of number of shots per patient per season, location of shots per administration, interval between administration, dosage per administration for primary endpoint compliance [ Time Frame: One RSV season, monthly ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01077271 on ClinicalTrials.gov Archive Site
  • 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.
  • Assessment of pain during injection according to pain scores [ Time Frame: One RSV season, monthly ] [ Designated as safety issue: No ]
  • Parents knowledge of burden of RSV disease via interview by physician [ Time Frame: One RSV season ] [ Designated as safety issue: No ]
  • Effectiveness of Synagis at the end of the observation period is checked by the physician by ranking in a visible analog scale [ Time Frame: One RSV season ] [ Designated as safety issue: No ]
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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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Medical practices specialized in pediatrics.

Premature Infants
Not Provided
Premature infants 33 - 35 wGA prophylaxed with palivizumab
Premature infants 33 - 35 weeks gestational age (wGA) prophylaxed with Synagis (palivizumab)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
124
May 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
up to 1 Year
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01077271
P11-040
No
Abbott
Abbott
Assign Data Management and Biostatistics GmbH
Study Director: Astrid Dworan-Timler, MD Abbott Austria
Abbott
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP