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Trial record 49 of 1404 for:    Peru

Effectiveness of Synagis (Palivizumab) Immunoprophylaxis in Preterm Infants With High Risk of Severe Respiratory Syncytial Virus (RSV) Infection (INSPIRA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01107535
Recruitment Status : Completed
First Posted : April 21, 2010
Results First Posted : April 23, 2012
Last Update Posted : October 31, 2012
Sponsor:
Information provided by (Responsible Party):
Abbott

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Respiratory Syncytial Virus Infection
Intervention Biological: Synagis (palivizumab), monoclonal antibody for passive immunoprophylaxis against severe RSV disease administered according to usual clinical practice.
Enrollment 82
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Infants Receiving Synagis (Palivizumab) Immunoprophylaxis
Hide Arm/Group Description Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
Period Title: Overall Study
Started 82
Number of Participants Analyzed 82
Completed 77
Not Completed 5
Reason Not Completed
Death             5
Arm/Group Title Infants Receiving Synagis (Palivizumab) Immunoprophylaxis
Hide Arm/Group Description Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
Overall Number of Baseline Participants 82
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 82 participants
68  (63)
[1]
Measure Description: The mean age of participants at the first injection of study drug.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants
Female
40
  48.8%
Male
42
  51.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Peru Number Analyzed 82 participants
82
Gestational age   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 82 participants
Gestational age less than 28 weeks 22
Gestational age >28 weeks and <32 weeks 60
[1]
Measure Description: Gestational age of participants.
1.Primary Outcome
Title Number of Hospital Admissions by Respiratory Syncytial Virus Infection
Hide Description The number of participants hospitalized for respiratory syncytial virus infection from the first dose of study drug up to the visit coinciding with the first birthday of the participant. An indirect immunofluorescence test (a laboratory technique used to detect the presence of viruses) was used to determine if hospitalized participants had respiratory syncytial virus infection.
Time Frame First year of life (up to 12 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis included all enrolled participants.
Arm/Group Title Infants Receiving Synagis (Palivizumab) Immunoprophylaxis
Hide Arm/Group Description:
Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
Overall Number of Participants Analyzed 82
Measure Type: Number
Unit of Measure: participants
2
2.Secondary Outcome
Title Number of Hospital Admission Days (All Causes)
Hide Description The mean (average) number days participants were hospitalized.
Time Frame Hospital admission to hospital discharge
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis included all participants who were hospitalized during the study. This includes 2 participants hospitalized due to respiratory syncytial virus infection and 8 participants hospitalized for other respiratory diseases.
Arm/Group Title Infants Receiving Synagis (Palivizumab) Immunoprophylaxis
Hide Arm/Group Description:
Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: days
18.4  (29.7)
3.Secondary Outcome
Title Number of Intensive Care Unit Days During the Hospital Admissions by Respiratory Syncytial Virus Infection
Hide Description The number of days spent in a hospital intensive care unit (ICU) are summarized for those participants requiring that type of care. An indirect immunofluorescence test (a laboratory technique used to detect the presence of viruses) was used to determine if hospitalized participants had respiratory syncytial virus infection.
Time Frame Hospital admission to hospital discharge
Hide Outcome Measure Data
Hide Analysis Population Description
Two participants with a total of 3 intensive care unit stays were analyzed. One participant was negative for respiratory syncytial virus during their first stay in the intensive care unit and was positive for respiratory syncytial virus at their second stay.
Arm/Group Title Infants Receiving Synagis (Palivizumab) Immunoprophylaxis
Hide Arm/Group Description:
Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: days
ICU stay length (n=1, RSV negative) 5
ICU stay length (n=1, Stay #1 of 2, RSV negative) 10
ICU stay length (n=1, Stay #2 of 2, RSV positive) 106
4.Secondary Outcome
Title Number of Ventilation Support Days (Supplemental Oxygen and Mechanical Ventilation) During the Hospital Admission
Hide Description The mean (average) number of days participants required supplemental oxygen during any hospital stay and the mean number of days participants required mechanical ventilation while in the intensive care unit.
Time Frame Hospital admission to hospital discharge
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis of supplemental oxygen included participants with any hospital stay during the study (n=10) and analysis of mechanical ventilation included the subgroup of participants with intensive care unit stays during the study (n=2).
Arm/Group Title Infants Receiving Synagis (Palivizumab) Immunoprophylaxis
Hide Arm/Group Description:
Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: days
Supplemental oxygen (n=10) 17  (32)
Mechanical ventilation (n=2) 36.7  (49)
5.Secondary Outcome
Title Number of Serious Adverse Events
Hide Description The number participants experiencing a serious adverse event. For additional information see the Reported Adverse Events section.
Time Frame Enrollment until 100 days after the last Synagis (palivizumab) dose
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis included all enrolled participants.
Arm/Group Title Infants Receiving Synagis (Palivizumab) Immunoprophylaxis
Hide Arm/Group Description:
Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
Overall Number of Participants Analyzed 82
Measure Type: Number
Unit of Measure: participants
11
Time Frame Adverse events were assessed throughout the study observation period until 100 days after the last dose of Synagis. Participants were followed for an average of 12.4 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Infants Receiving Synagis (Palivizumab) Immunoprophylaxis
Hide Arm/Group Description Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
All-Cause Mortality
Infants Receiving Synagis (Palivizumab) Immunoprophylaxis
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Infants Receiving Synagis (Palivizumab) Immunoprophylaxis
Affected / at Risk (%) # Events
Total   11/82 (13.41%)    
Cardiac disorders   
Cardio-respiratory arrest   1/82 (1.22%)  1
Eye disorders   
Retinopathy of immaturity   1/82 (1.22%)  1
Gastrointestinal disorders   
Intussusception   1/82 (1.22%)  1
General disorders   
Sudden infant death syndrome   1/82 (1.22%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumonia   4/82 (4.88%)  4
Atelectasis neonatal   1/82 (1.22%)  1
Bronchopulmonary dysplasia   1/82 (1.22%)  1
Bronchial obstruction   2/82 (2.44%)  2
Respiratory syncytial virus infection   1/82 (1.22%)  1
Upper respiratory tract infection   1/82 (1.22%)  1
Apnea   1/82 (1.22%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Infants Receiving Synagis (Palivizumab) Immunoprophylaxis
Affected / at Risk (%) # Events
Total   17/82 (20.73%)    
Infections and infestations   
Diarrhoea infectious   2/82 (2.44%)  2
Respiratory, thoracic and mediastinal disorders   
Pharyngitis   7/82 (8.54%)  8
Bronchial obstruction   5/82 (6.10%)  8
Pneumonia   1/82 (1.22%)  1
Bronchiolitis   1/82 (1.22%)  1
Nasopharyngitis   2/82 (2.44%)  3
Tracheobronchitis   1/82 (1.22%)  1
Skin and subcutaneous tissue disorders   
Urticaria   1/82 (1.22%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Medical Services
Organization: Abbott
Phone: 1-800-633-9110
Layout table for additonal information
Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01107535     History of Changes
Other Study ID Numbers: PMOS-PERU 07-01
First Submitted: February 20, 2010
First Posted: April 21, 2010
Results First Submitted: February 7, 2012
Results First Posted: April 23, 2012
Last Update Posted: October 31, 2012