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

• 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: Abbott
• 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 ]

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

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

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