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

Completed

Conditions: Premature Infants

Registration Number: NCT01077271

Lead Sponsor: Abbott

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 available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 124

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Injections Per Patient Per Season	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	One RSV season (5 months)	The body site of injection administration for participants at each study visit.
Interval Between Administrations	One RSV season (5 months)	The average number of days that elapsed between palivizumab injections administered at the previous study visit.
Dosage Per Administration	One RSV season (5 months)	The median dose and range of palivizumab (milligrams) that was administered at each study visit.

Secondary Outcome Measures

Name	Time	Method
Parents Knowledge of Burden of RSV Disease Via Interview by Physician	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	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.
Assessment of Pain During Injection According to Pain Scores (VAS and Modified Behavioral Pain Scale)	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.

Trial Locations

Locations (45): Site Reference ID/Investigator# 40440
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Schorfling, Austria
Site Reference ID/Investigator# 27765
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Scheibbs, Austria
Site Reference ID/Investigator# 30850
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St Polten, Austria
Site Reference ID/Investigator# 27770
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Klagenfurt, Austria
Site Reference ID/Investigator# 52871
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Amstetten, Austria
Site Reference ID/Investigator# 52870
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Mattersburg, Austria
Site Reference ID/Investigator# 30843
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Hollabrunn, Austria
Site Reference ID/Investigator# 30842
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Krems, Austria
Site Reference ID/Investigator# 52867
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Linz, Austria
Site Reference ID/Investigator# 27772
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Amstetten, Austria
Site Reference ID/Investigator# 40437
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Ganserndorf, Austria
Site Reference ID/Investigator# 27771
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Leonding, Austria
Site Reference ID/Investigator# 27767
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Judenburg, Austria
Site Reference ID/Investigator# 27777
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Klosterneuburg, Austria
Site Reference ID/Investigator# 40445
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Linz, Austria
Site Reference ID/Investigator# 40447
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Vienna, Austria
Site Reference ID/Investigator# 27773
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Vienna, Austria
Site Reference ID/Investigator# 52879
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Vienna, Austria
Site Reference ID/Investigator# 52873
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Feldkirch, Austria
Site Reference ID/Investigator# 58943
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Linz, Austria
Site Reference ID/Investigator# 18603
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Linz, Austria
Site Reference ID/Investigator# 48262
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Neufeld, Austria
Site Reference ID/Investigator# 52874
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Linz, Austria
Site Reference ID/Investigator# 27764
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Telfs, Austria
Site Reference ID/Investigator# 27775
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Purkersdorf, Austria
Site Reference ID/Investigator# 30845
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Vienna, Austria
Site Reference ID/Investigator# 30848
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Tulln, Austria
Site Reference ID/Investigator# 27776
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Tulln, Austria
Site Reference ID/Investigator# 40439
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Traisen, Austria
Site Reference ID/Investigator# 30849
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Vienna, Austria
Site Reference ID/Investigator# 40432
🇦🇹
Vienna, Austria
Site Reference ID/Investigator# 27769
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Vienna, Austria
Site Reference ID/Investigator# 40446
🇦🇹
Vienna, Austria
Site Reference ID/Investigator# 27762
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Vienna, Austria
Site Reference ID/Investigator# 52878
🇦🇹
Vienna, Austria
Site Reference ID/Investigator# 27774
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Vienna, Austria
Site Reference ID/Investigator# 27763
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Vienna, Austria
Site Reference ID/Investigator# 40442
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Vienna, Austria
Site Reference ID/Investigator# 30846
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Vienna, Austria
Site Reference ID/Investigator# 58942
🇦🇹
Vienna, Austria
Site Reference ID/Investigator# 30847
🇦🇹
Vienna, Austria
Site Reference ID/Investigator# 30851
🇦🇹
Vienna, Austria
Site Reference ID/Investigator# 57793
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Vienna, Austria
Site Reference ID/Investigator# 30852
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Vienna, Austria
Site Reference ID/Investigator# 40425
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Vienna, Austria