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

August 20, 2012 updated by: Abbott

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
124

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Amstetten, Austria, 3300
        • Site Reference ID/Investigator# 27772
      • Amstetten, Austria, 3300
        • Site Reference ID/Investigator# 52871
      • Feldkirch, Austria, 6800
        • Site Reference ID/Investigator# 52873
      • Ganserndorf, Austria, 2230
        • Site Reference ID/Investigator# 40437
      • Hollabrunn, Austria, 2020
        • Site Reference ID/Investigator# 30843
      • Judenburg, Austria, 8750
        • Site Reference ID/Investigator# 27767
      • Klagenfurt, Austria, 9020
        • Site Reference ID/Investigator# 27770
      • Klosterneuburg, Austria, 3400
        • Site Reference ID/Investigator# 27777
      • Krems, Austria, 3500
        • Site Reference ID/Investigator# 30842
      • Leonding, Austria, 4060
        • Site Reference ID/Investigator# 27771
      • Linz, Austria, 4020
        • Site Reference ID/Investigator# 52867
      • Linz, Austria, 4020
        • Site Reference ID/Investigator# 58943
      • Linz, Austria, 4030
        • Site Reference ID/Investigator# 18603
      • Linz, Austria, 4040
        • Site Reference ID/Investigator# 40445
      • Linz, Austria, 4040
        • Site Reference ID/Investigator# 52874
      • Mattersburg, Austria, 7210
        • Site Reference ID/Investigator# 52870
      • Neufeld, Austria, 2491
        • Site Reference ID/Investigator# 48262
      • Purkersdorf, Austria, 3002
        • Site Reference ID/Investigator# 27775
      • Scheibbs, Austria, 3270
        • Site Reference ID/Investigator# 27765
      • Schorfling, Austria, 4861
        • Site Reference ID/Investigator# 40440
      • St Polten, Austria, 3100
        • Site Reference ID/Investigator# 30850
      • Telfs, Austria, 6410
        • Site Reference ID/Investigator# 27764
      • Traisen, Austria, 3160
        • Site Reference ID/Investigator# 40439
      • Tulln, Austria, 3400
        • Site Reference ID/Investigator# 30848
      • Tulln, Austria, 3430
        • Site Reference ID/Investigator# 27776
      • Vienna, Austria, 1020
        • Site Reference ID/Investigator# 30845
      • Vienna, Austria, 1030
        • Site Reference ID/Investigator# 30849
      • Vienna, Austria, 1030
        • Site Reference ID/Investigator# 40432
      • Vienna, Austria, 1030
        • Site Reference ID/Investigator# 40447
      • Vienna, Austria, 1040
        • Site Reference ID/Investigator# 27773
      • Vienna, Austria, 1060
        • Site Reference ID/Investigator# 52879
      • Vienna, Austria, 1090
        • Site Reference ID/Investigator# 27769
      • Vienna, Austria, 1100
        • Site Reference ID/Investigator# 40446
      • Vienna, Austria, 1100
        • Site Reference ID/Investigator# 52878
      • Vienna, Austria, 1110
        • Site Reference ID/Investigator# 27774
      • Vienna, Austria, 1120
        • Site Reference ID/Investigator# 27762
      • Vienna, Austria, 1150
        • Site Reference ID/Investigator# 27763
      • Vienna, Austria, 1190
        • Site Reference ID/Investigator# 40442
      • Vienna, Austria, 1200
        • Site Reference ID/Investigator# 30851
      • Vienna, Austria, 1200
        • Site Reference ID/Investigator# 58942
      • Vienna, Austria, 1210
        • Site Reference ID/Investigator# 30846
      • Vienna, Austria, 1210
        • Site Reference ID/Investigator# 30847
      • Vienna, Austria, 1210
        • Site Reference ID/Investigator# 57793
      • Vienna, Austria, 1220
        • Site Reference ID/Investigator# 30852
      • Vienna, Austria, 1220
        • Site Reference ID/Investigator# 40425

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Medical practices specialized in pediatrics.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Premature infants 33 - 35 wGA prophylaxed with palivizumab
Premature infants 33 - 35 weeks gestational age (wGA) prophylaxed with Synagis (palivizumab)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
One RSV season (5 months)
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.
One RSV season (5 months)
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.
One RSV season (5 months)
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.
One RSV season (5 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
One RSV season (5 months)
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.
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
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.
One RSV season (5 months), end of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Assign Data Management and Biostatistics GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Astrid Dworan-Timler, MD, Abbott Austria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 1, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P11-040

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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