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

NCT01077271 | Completed Results

• 1 other identifier: P11-040
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 45

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.

Conditions

Premature Infants

Keywords

Premature infants; Respiratory Syncytial Virus (RSV); Compliance; Palivizumab

Outcome Measures

Primary Outcomes (4)

• 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)

• Body Site of Injections Per Administration

  The body site of injection administration for participants at each study visit.

  One RSV season (5 months)

• Interval Between Administrations

  The average number of days that elapsed between palivizumab injections administered at the previous study visit.

  One RSV season (5 months)

• Dosage Per Administration

  The median dose and range of palivizumab (milligrams) that was administered at each study visit.

  One RSV season (5 months)

Secondary Outcomes (3)

• Assessment of Pain During Injection According to Pain Scores (VAS and Modified Behavioral Pain Scale)

  One RSV season (5 months)

• Parents Knowledge of Burden of RSV Disease Via Interview by Physician

  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

  One RSV season (5 months), end of study

Study Arms (1)

Premature infants 33 - 35 wGA prophylaxed with palivizumab

Premature infants 33 - 35 weeks gestational age (wGA) prophylaxed with Synagis (palivizumab)

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Medical practices specialized in pediatrics.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott: lead
• Assign Data Management and Biostatistics GmbH: collaborator

Study Sites (45)

Site Reference ID/Investigator# 27772

Amstetten, 3300, Austria

Location

Site Reference ID/Investigator# 52871

Amstetten, 3300, Austria

Location

Site Reference ID/Investigator# 52873

Feldkirch, 6800, Austria

Location

Site Reference ID/Investigator# 40437

Gänserndorf, 2230, Austria

Location

Site Reference ID/Investigator# 30843

Hollabrunn, 2020, Austria

Location

Site Reference ID/Investigator# 27767

Judenburg, 8750, Austria

Location

Site Reference ID/Investigator# 27770

Klagenfurt, 9020, Austria

Location

Site Reference ID/Investigator# 27777

Klosterneuburg, 3400, Austria

Location

Site Reference ID/Investigator# 30842

Krems, 3500, Austria

Location

Site Reference ID/Investigator# 27771

Leonding, 4060, Austria

Location

Site Reference ID/Investigator# 52867

Linz, 4020, Austria

Location

Site Reference ID/Investigator# 58943

Linz, 4020, Austria

Location

Site Reference ID/Investigator# 18603

Linz, 4030, Austria

Location

Site Reference ID/Investigator# 40445

Linz, 4040, Austria

Location

Site Reference ID/Investigator# 52874

Linz, 4040, Austria

Location

Site Reference ID/Investigator# 52870

Mattersburg, 7210, Austria

Location

Site Reference ID/Investigator# 48262

Neufeld, 2491, Austria

Location

Site Reference ID/Investigator# 27775

Purkersdorf, 3002, Austria

Location

Site Reference ID/Investigator# 30850

Sankt Pölten, 3100, Austria

Location

Site Reference ID/Investigator# 27765

Scheibbs, 3270, Austria

Location

Site Reference ID/Investigator# 40440

Schörfling, 4861, Austria

Location

Site Reference ID/Investigator# 27764

Telfs, 6410, Austria

Location

Site Reference ID/Investigator# 40439

Traisen, 3160, Austria

Location

Site Reference ID/Investigator# 30848

Tulln, 3400, Austria

Location

Site Reference ID/Investigator# 27776

Tulln, 3430, Austria

Location

Site Reference ID/Investigator# 30845

Vienna, 1020, Austria

Location

Site Reference ID/Investigator# 30849

Vienna, 1030, Austria

Location

Site Reference ID/Investigator# 40432

Vienna, 1030, Austria

Location

Site Reference ID/Investigator# 40447

Vienna, 1030, Austria

Location

Site Reference ID/Investigator# 27773

Vienna, 1040, Austria

Location

Site Reference ID/Investigator# 52879

Vienna, 1060, Austria

Location

Site Reference ID/Investigator# 27769

Vienna, 1090, Austria

Location

Site Reference ID/Investigator# 40446

Vienna, 1100, Austria

Location

Site Reference ID/Investigator# 52878

Vienna, 1100, Austria

Location

Site Reference ID/Investigator# 27774

Vienna, 1110, Austria

Location

Site Reference ID/Investigator# 27762

Vienna, 1120, Austria

Location

Site Reference ID/Investigator# 27763

Vienna, 1150, Austria

Location

Site Reference ID/Investigator# 40442

Vienna, 1190, Austria

Location

Site Reference ID/Investigator# 30851

Vienna, 1200, Austria

Location

Site Reference ID/Investigator# 58942

Vienna, 1200, Austria

Location

Site Reference ID/Investigator# 30846

Vienna, 1210, Austria

Location

Site Reference ID/Investigator# 30847

Vienna, 1210, Austria

Location

Site Reference ID/Investigator# 57793

Vienna, 1210, Austria

Location

Site Reference ID/Investigator# 30852

Vienna, 1220, Austria

Location

Site Reference ID/Investigator# 40425

Vienna, 1220, Austria

Location

Related Links

• Related Info

MeSH Terms

Conditions

Premature Birth; Patient Compliance

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Global Medical Services
• Organization: Abbott

1-800-633-9110

Study Officials

• Astrid Dworan-Timler, MD

  Abbott Austria

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2010
• First Posted: March 1, 2010
• Study Start: October 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: August 21, 2012
• Results First Posted: August 21, 2012

Record last verified: 2012-08

Locations

AU (45)