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

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ClinicalTrials.gov Identifier: NCT01077271
Recruitment Status : Completed
First Posted : March 1, 2010
Results First Posted : August 21, 2012
Last Update Posted : August 21, 2012
Sponsor:
Collaborator:
Assign Data Management and Biostatistics GmbH
Information provided by (Responsible Party):
Abbott

Tracking Information
First Submitted Date February 25, 2010
First Posted Date March 1, 2010
Results First Submitted Date May 17, 2012
Results First Posted Date August 21, 2012
Last Update Posted Date August 21, 2012
Study Start Date October 2008
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 20, 2012)
  • Number of Injections Per Patient Per Season [ Time Frame: One RSV season (5 months) ]
    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) ]
    The body site of injection administration for participants at each study visit.
  • Interval Between Administrations [ Time Frame: One RSV season (5 months) ]
    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) ]
    The median dose and range of palivizumab (milligrams) that was administered at each study visit.
Original Primary Outcome Measures
 (submitted: February 25, 2010)
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 ]
Change History
Current Secondary Outcome Measures
 (submitted: August 20, 2012)
  • Assessment of Pain During Injection According to Pain Scores (VAS and Modified Behavioral Pain Scale) [ Time Frame: One RSV season (5 months) ]
    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) ]
    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 ]
    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.
Original Secondary Outcome Measures
 (submitted: February 25, 2010)
  • Assessment of pain during injection according to pain scores [ Time Frame: One RSV season, monthly ]
  • Parents Knowledge of Burden of RSV Disease Via Interview by Physician [ Time Frame: One RSV season ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Medical practices specialized in pediatrics.
Condition Premature Infants
Intervention Not Provided
Study Groups/Cohorts Premature infants 33 - 35 wGA prophylaxed with palivizumab
Premature infants 33 - 35 weeks gestational age (wGA) prophylaxed with Synagis (palivizumab)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 19, 2012)
124
Original Estimated Enrollment
 (submitted: February 25, 2010)
200
Actual Study Completion Date May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 1 Year   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria
Removed Location Countries  
 
Administrative Information
NCT Number NCT01077271
Other Study ID Numbers P11-040
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Abbott
Study Sponsor Abbott
Collaborators Assign Data Management and Biostatistics GmbH
Investigators
Study Director: Astrid Dworan-Timler, MD Abbott Austria
PRS Account Abbott
Verification Date August 2012