Trial Outcomes & Findings for Effectiveness of Synagis (Palivizumab) Immunoprophylaxis in Preterm Infants With High Risk of Severe Respiratory Syncytial Virus (RSV) Infection (NCT NCT01107535)

Last Updated: 2012-10-31

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

82 participants

Primary outcome timeframe

First year of life (up to 12 months)

Results posted on

2012-10-31

Participant Flow

Participant milestones

Participant milestones
Measure	Infants Receiving Synagis (Palivizumab) Immunoprophylaxis 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 Study STARTED	82
Overall Study Number of Participants Analyzed	82
Overall Study COMPLETED	77
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Infants Receiving Synagis (Palivizumab) Immunoprophylaxis 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 Study Death	5

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Infants Receiving Synagis (Palivizumab) Immunoprophylaxis n=82 Participants 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.
Age Continuous	68 days STANDARD_DEVIATION 63 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants
Region of Enrollment Peru	82 participants n=5 Participants
Gestational age Gestational age less than 28 weeks	22 participants n=5 Participants
Gestational age Gestational age >28 weeks and <32 weeks	60 participants n=5 Participants

PRIMARY outcome

Timeframe: First year of life (up to 12 months)

Population: Analysis included all enrolled participants.

Outcome measures

Outcome measures
Measure	Infants Receiving Synagis (Palivizumab) Immunoprophylaxis n=82 Participants 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.
Number of Hospital Admissions by Respiratory Syncytial Virus Infection	2 participants

SECONDARY outcome

Timeframe: Hospital admission to hospital discharge

Population: 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.

The mean (average) number days participants were hospitalized.

Outcome measures

Outcome measures
Measure	Infants Receiving Synagis (Palivizumab) Immunoprophylaxis n=10 Participants 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.
Number of Hospital Admission Days (All Causes)	18.4 days Standard Deviation 29.7

SECONDARY outcome

Timeframe: Hospital admission to hospital discharge

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Infants Receiving Synagis (Palivizumab) Immunoprophylaxis n=2 Participants 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.
Number of Intensive Care Unit Days During the Hospital Admissions by Respiratory Syncytial Virus Infection ICU stay length (n=1, RSV negative)	5 days
Number of Intensive Care Unit Days During the Hospital Admissions by Respiratory Syncytial Virus Infection ICU stay length (n=1, Stay #1 of 2, RSV negative)	10 days
Number of Intensive Care Unit Days During the Hospital Admissions by Respiratory Syncytial Virus Infection ICU stay length (n=1, Stay #2 of 2, RSV positive)	106 days

SECONDARY outcome

Timeframe: Hospital admission to hospital discharge

Population: 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).

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.

Outcome measures

Outcome measures
Measure	Infants Receiving Synagis (Palivizumab) Immunoprophylaxis n=10 Participants 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.
Number of Ventilation Support Days (Supplemental Oxygen and Mechanical Ventilation) During the Hospital Admission Supplemental oxygen (n=10)	17 days Standard Deviation 32
Number of Ventilation Support Days (Supplemental Oxygen and Mechanical Ventilation) During the Hospital Admission Mechanical ventilation (n=2)	36.7 days Standard Deviation 49

SECONDARY outcome

Timeframe: Enrollment until 100 days after the last Synagis (palivizumab) dose

Population: Analysis included all enrolled participants.

The number participants experiencing a serious adverse event. For additional information see the Reported Adverse Events section.

Outcome measures

Outcome measures
Measure	Infants Receiving Synagis (Palivizumab) Immunoprophylaxis n=82 Participants 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.
Number of Serious Adverse Events	11 participants

Adverse Events

Infants Receiving Synagis (Palivizumab) Immunoprophylaxis

Serious events: 11 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Infants Receiving Synagis (Palivizumab) Immunoprophylaxis n=82 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Pneumonia	4.9% 4/82 • Number of events 4 • 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.
Respiratory, thoracic and mediastinal disorders Atelectasis neonatal	1.2% 1/82 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary dysplasia	1.2% 1/82 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	2.4% 2/82 • Number of events 2 • 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.
Respiratory, thoracic and mediastinal disorders Respiratory syncytial virus infection	1.2% 1/82 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	1.2% 1/82 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Apnea	1.2% 1/82 • Number of events 1 • 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.
Eye disorders Retinopathy of immaturity	1.2% 1/82 • Number of events 1 • 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.
General disorders Sudden infant death syndrome	1.2% 1/82 • Number of events 1 • 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.
Gastrointestinal disorders Intussusception	1.2% 1/82 • Number of events 1 • 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.
Cardiac disorders Cardio-respiratory arrest	1.2% 1/82 • Number of events 1 • 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.

Other adverse events

Other adverse events
Measure	Infants Receiving Synagis (Palivizumab) Immunoprophylaxis n=82 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Pharyngitis	8.5% 7/82 • Number of events 8 • 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.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	6.1% 5/82 • Number of events 8 • 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.
Respiratory, thoracic and mediastinal disorders Pneumonia	1.2% 1/82 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Bronchiolitis	1.2% 1/82 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Nasopharyngitis	2.4% 2/82 • Number of events 3 • 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.
Respiratory, thoracic and mediastinal disorders Tracheobronchitis	1.2% 1/82 • Number of events 1 • 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.
Infections and infestations Diarrhoea infectious	2.4% 2/82 • Number of events 2 • 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.
Skin and subcutaneous tissue disorders Urticaria	1.2% 1/82 • Number of events 1 • 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.

Additional Information

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