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NCT Number: NCT01077271

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

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.

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Key information

Conditions

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

Age range

Up to 1 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Site Reference ID/Investigator# 27772, Amstetten, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Collaborators

  • Assign Data Management and Biostatistics GmbH

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Mar 1, 2010
Registry last updated
Aug 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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