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.
Study Type
OBSERVATIONAL
Enrollment
124
Site Reference ID/Investigator# 27772
Amstetten, Austria
Site Reference ID/Investigator# 52871
Amstetten, Austria
Site Reference ID/Investigator# 52873
Feldkirch, Austria
Site Reference ID/Investigator# 40437
Gänserndorf, Austria
Site Reference ID/Investigator# 30843
Hollabrunn, Austria
Number of Injections Per Patient Per Season
The average number of injections administered per participant within a respiratory syncytial virus season.
Time frame: One RSV season (5 months)
Body Site of Injections Per Administration
The body site of injection administration for participants at each study visit.
Time frame: One RSV season (5 months)
Interval Between Administrations
The average number of days that elapsed between palivizumab injections administered at the previous study visit.
Time frame: One RSV season (5 months)
Dosage Per Administration
The median dose and range of palivizumab (milligrams) that was administered at each study visit.
Time frame: One RSV season (5 months)
Assessment of Pain During Injection According to Pain Scores (VAS and Modified Behavioral Pain Scale)
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.
Time frame: One RSV season (5 months)
Parents Knowledge of Burden of RSV Disease Via Interview by Physician
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.
Time frame: One RSV season (5 months)
Effectiveness of Palivizumab at the End of the Observation Period is Checked by the Physician by Ranking in a Visible Analog Scale
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.
Time frame: One RSV season (5 months), end of study
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Site Reference ID/Investigator# 27767
Judenburg, Austria
Site Reference ID/Investigator# 27770
Klagenfurt, Austria
Site Reference ID/Investigator# 27777
Klosterneuburg, Austria
Site Reference ID/Investigator# 30842
Krems, Austria
Site Reference ID/Investigator# 27771
Leonding, Austria
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