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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

Study Description
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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.

Condition or disease
Premature Infants

Study Design
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Study Type : Observational
Actual Enrollment : 124 participants
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
Study Start Date : October 2008
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Palivizumab

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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01077271


Locations
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Sponsors and Collaborators
Abbott
Assign Data Management and Biostatistics GmbH
Investigators
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Study Director: Astrid Dworan-Timler, MD Abbott Austria
More Information
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Additional Information:

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Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01077271    
Other Study ID Numbers: P11-040
First Posted: March 1, 2010    Key Record Dates
Results First Posted: August 21, 2012
Last Update Posted: August 21, 2012
Last Verified: August 2012
Keywords provided by Abbott:
Premature infants
Respiratory Syncytial Virus (RSV)
Compliance
Palivizumab
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications