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

Premature Infants Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01077271
• Other study ID #: P11-040
• Status: Completed
• Phase: N/A
• First received: February 25, 2010
• Last updated: August 20, 2012
• Start date: October 2008
• Est. completion date: May 2011

Study information

• Verified date: August 2012
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Year

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Premature Birth
• Premature Infants

Locations

Country	Name	City	State
Austria	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	Ganserndorf
Austria	Site Reference ID/Investigator# 30843	Hollabrunn
Austria	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	Site Reference ID/Investigator# 18603	Linz
Austria	Site Reference ID/Investigator# 40445	Linz
Austria	Site Reference ID/Investigator# 52867	Linz
Austria	Site Reference ID/Investigator# 52874	Linz
Austria	Site Reference ID/Investigator# 58943	Linz
Austria	Site Reference ID/Investigator# 52870	Mattersburg
Austria	Site Reference ID/Investigator# 48262	Neufeld
Austria	Site Reference ID/Investigator# 27775	Purkersdorf
Austria	Site Reference ID/Investigator# 27765	Scheibbs
Austria	Site Reference ID/Investigator# 40440	Schorfling
Austria	Site Reference ID/Investigator# 30850	St Polten
Austria	Site Reference ID/Investigator# 27764	Telfs
Austria	Site Reference ID/Investigator# 40439	Traisen
Austria	Site Reference ID/Investigator# 27776	Tulln
Austria	Site Reference ID/Investigator# 30848	Tulln
Austria	Site Reference ID/Investigator# 27762	Vienna
Austria	Site Reference ID/Investigator# 27763	Vienna
Austria	Site Reference ID/Investigator# 27769	Vienna
Austria	Site Reference ID/Investigator# 27773	Vienna
Austria	Site Reference ID/Investigator# 27774	Vienna
Austria	Site Reference ID/Investigator# 30845	Vienna
Austria	Site Reference ID/Investigator# 30846	Vienna
Austria	Site Reference ID/Investigator# 30847	Vienna
Austria	Site Reference ID/Investigator# 30849	Vienna
Austria	Site Reference ID/Investigator# 30851	Vienna
Austria	Site Reference ID/Investigator# 30852	Vienna
Austria	Site Reference ID/Investigator# 40425	Vienna
Austria	Site Reference ID/Investigator# 40432	Vienna
Austria	Site Reference ID/Investigator# 40442	Vienna
Austria	Site Reference ID/Investigator# 40446	Vienna
Austria	Site Reference ID/Investigator# 40447	Vienna
Austria	Site Reference ID/Investigator# 52878	Vienna
Austria	Site Reference ID/Investigator# 52879	Vienna
Austria	Site Reference ID/Investigator# 57793	Vienna
Austria	Site Reference ID/Investigator# 58942	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Abbott	Assign Data Management and Biostatistics GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Injections Per Patient Per Season	The average number of injections administered per participant within a respiratory syncytial virus season.	One RSV season (5 months)	No
Primary	Body Site of Injections Per Administration	The body site of injection administration for participants at each study visit.	One RSV season (5 months)	No
Primary	Interval Between Administrations	The average number of days that elapsed between palivizumab injections administered at the previous study visit.	One RSV season (5 months)	No
Primary	Dosage Per Administration	The median dose and range of palivizumab (milligrams) that was administered at each study visit.	One RSV season (5 months)	No
Secondary	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.	One RSV season (5 months)	No
Secondary	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.	One RSV season (5 months)	No
Secondary	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.	One RSV season (5 months), end of study	No

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