Skip to main content
OpenTrials
Completed

NCT Number: NCT02282982

Observational Program to Assess Respiratory Syncytial Virus (RSV) Hospitalization Rate in Population of Children at High-risk of Serious RSV Illness Who Received Palivizumab Immunoprophylaxis

This was a non-interventional, prospective, multi-center study with no control group designed to assess the effectiveness of palivizumab in a population of infants at high-risk of serious Respiratory Syncytial Virus (RSV) illness (infants born ≤ 35 weeks of gestation and infants ≤24 months with Bronchopulmonary Dysplasia (BPD) or Congenital Heart Disease (CHD)). Participants received immunoprophylaxis during the RSV season, defined as October 2014 through April 2015, in routine clinical settings throughout the Russian Federation.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Respiratory Syncytial Virus (RSV)

Age range

Up to 2 year

Sex eligibility

All sexes

Study type

Observational

About this study

Participants received intramuscular injections of palivizumab according to physicians' prescription and the local label. The local label recommended 1 month injection intervals between 5 sequential injections at a dose of 15 mg/kg. Participants could have received from 3 to 5 monthly injections of palivizumab during the 2014 - 2015 RSV season and the duration of this study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Planned prescription of palivizumab for immunoprophylaxis during RSV season or participants for whom palivizumab was prescribed and who received the first dose of palivizumab no later than 60 days before enrollment in the study
  • Infants at high risk of severe RSV infection defined as fulfilling at least one of the following:
  • Infants born ≤35 weeks gestational age AND are ≤6 months of age at the onset of the RSV season;
  • Infants ≤24 months of age AND with a diagnosis of BPD (defined as oxygen requirement at a corrected gestational age of 36 weeks);
  • Infants ≤24 months of age with hemodynamically significant CHD, unoperated or partially corrected.
  • Written authorization to use individual data signed by parents or child representative

Exclusion criteria

  • Major congenital malformation aside from CHD
  • Chronic pulmonary disease other than BPD
  • Acute period of any infection
  • Contraindication to palivizumab prescription according to local label
  • Administration of a product possibly containing RSV-neutralizing antibody within 30 days prior to enrollment or current administration (includes, but is not restricted to, the following: RSV hyperimmunoglobulin, polyclonal intravenous immunoglobulin, cytomegalovirus hyperimmunoglobulin, varicella zoster hyperimmunoglobulin)

Treatment and study plan

Primary outcomes

  1. Proportion of Infants Hospitalized for Lower Respiratory Tract Infection (LRTI) With a Positive Respiratory Syncytial Virus (RSV) Diagnostic Test

    Time frame: Approximately 7 months

    Hospitalizations for LRTI with positive RSV diagnostic tests were documented at study visits.

  2. Proportion of Infants Who Died From a Confirmed Respiratory Syncytial Virus (RSV) Infection

    Time frame: Approximately 7 months

    Deaths caused by RSV during the study were to be confirmed by autopsy or clinical history and positive virologic diagnostic tests.

Secondary outcomes

  1. Median Length of Stay (LOS) of Lower Respiratory Tract Infection (LRTI) Hospitalization With a Positive Respiratory Syncytial Virus (RSV) Test

    Time frame: Approximately 7 months

    The duration of hospitalizations due to LRTI which were accompanied by a positive RSV diagnostic test was documented.

  2. Proportion of Participants With Intensive Care Unit (ICU) Admission Among Hospitalized Participants

    Time frame: Approximately 7 months

    The number of hospitalized participants admitted to the Intensive Care Unit was documented.

  3. Median Length of Stay (LOS) of Participants in the Intensive Care Unit (ICU)

    Time frame: Approximately 7 months

    The median length of stay of hospitalized participants in the Intensive Care Unit was calculated.

  4. Proportion of Participants Who Received Supplemental Oxygen While Hospitalized

    Time frame: Approximately 7 months

    The proportion of participants who received supplemental oxygen while hospitalized was documented.

  5. Proportion of Participants Who Received Mechanical Ventilation While Hospitalized

    Time frame: Approximately 7 months

    The proportion of participants who received mechanical ventilation while hospitalized was documented.

  6. Proportion of Participants With Missed Doses of Palivizumab

    Time frame: Approximately 7 months

    The proportion of participants with missed or delayed doses of palivizumab was documented.

  7. Proportion of Participants With Co-morbidities During Hospitalizations

    Time frame: Approximately 7 months

    The proportion of participants with co-morbidities during hospitalizations was documented. Co-morbidities were defined by the International Statistical Classification of Diseases 10 revision (ICD-10).

  8. Median Duration of Mechanical Ventilation Administration During Hospitalizations

    Time frame: Approximately 7 months

    The median duration of mechanical ventilation administration during hospitalizations was calculated.

  9. Median Duration of Oxygen Administration During Hospitalizations

    Time frame: Approximately 7 months

    The median duration of mechanical oxygen administration during hospitalizations was calculated.

  10. Proportion of Participants With a Particular Co-morbidity

    Time frame: Approximately 7 months

    The proportion of participants with co-morbidities was documented. Co-morbidities were defined by the International Statistical Classification of Diseases 10 revision (ICD-10).

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

Prospective, Multi-Center, Observational Program to Assess RSV Hospitalization Rate in Population of Children at High-risk of Serious RSV Illness Who Received Palivizumab Immunoprophylaxis in Routine Clinical Setting in the Russian Federation

Acronym: SUNRISE

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 5, 2014
Registry last updated
Jul 29, 2016

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.