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
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||124 participants|
|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|
Premature infants 33 - 35 wGA prophylaxed with palivizumab
Premature infants 33 - 35 weeks gestational age (wGA) prophylaxed with Synagis (palivizumab)
- 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.
- 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.
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
|Study Director:||Astrid Dworan-Timler, MD||Abbott Austria|