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Completed

NCT Number: NCT01297504

A One-Year Observation of Palivizumab in Infants at Risk for Respiratory Syncytial Virus Infection in Latin America

The study was designed to gather information regarding the use of palivizumab for the prophylaxis for respiratory syncytial virus (RSV) infection in high-risk infants in selected countries within Latin America.

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Key information

Age range

Up to 2 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Site Reference ID/Investigator# 52182, Buenos Aires, Argentina

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About this study

RSV causes significant disease. There is a paucity of data from developing countries even though existing data clearly indicate that RSV accounts for a high proportion of acute respiratory illnesses (ARIs) in children.

This is a multi-center study in a cohort of infants at risk for RSV infection in Latin America who have received palivizumab in the usual manner in accordance with the terms of marketing authorization with regard to dose, population and indication. Enrolled participants were followed for one year after their first dose of palivizumab. Epidemiological and clinical data as well as information about compliance, hospitalizations and safety was collected.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children with a history of bronchopulmonary dysplasia, infants with a history of prematurity (less than or equal to 35 weeks gestational age), or children with hemodynamically significant congenital heart disease who received the first dose of palivizumab within the 2 weeks prior to the signature of the Informed Consent Form.
  • Parent or legal guardian of child provides written Informed Consent

Exclusion criteria

  • Children excluded from receiving palivizumab as per local guidelines

Treatment and study plan

Primary outcomes

  1. Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection

    Time frame: Baseline

    Study participants were characterized at Baseline by history of bronchopulmonary dysplasia, history of prematurity (less than or equal to 35 weeks gestational age), children with hemodynamically significant congenital heart disease (CHD), the presence of cohabitants less than 6 years old, possible exposure to indoor tobacco smoke, day care attendance, asthmatic or atopic mother, smoking during pregnancy, breastfeeding, prenatal assistance (4 or more visits during pregnancy), neonatal hospitalization care, history of neonatal assisted ventilation, and mother education level (completed primary school).

  2. Distribution of Comorbidities in Study Participants

    Time frame: Baseline

    The percentage of participants with each and combinations of the three comorbidities for which palivizumab is indicated.

Secondary outcomes

  1. Number of Participants With Hospitalizations for Lower Respiratory Tract Infection and RSV

    Time frame: 12 months

    The number of participants with hospitalizations due to lower respiratory tract infection (LRTI) and hospitalizations due to lower respiratory tract infection caused by RSV.

  2. Characterization of Hospitalization Episodes Due to Lower Respiratory Tract Infection and RSV

    Time frame: 12 months

  3. Risk Factors for Hospitalization

    Time frame: Baseline and 12 months

    Variables that could act as risk factors for hospitalization for lower respiratory tract infection were tested in univariate and multivariate Poisson regression models. Baseline characteristics, such as age, gender, birth weight and comorbidities were included as covariates in the Poisson regression model. Variables for multivariate analysis were added applying forward selection. Gestational age and birth weight were included as continuous variables, considering that the higher they were the better they could act as a protection factor for hospitalization due to respiratory infection.

  4. Compliance to Prescribed Palivizumab

    Time frame: 12 months

    Compliance to prescribed palivizumab was calculated based on the number of doses received versus the expected number of doses for each participant. The expected number of doses for each participant was estimated based on seasonality and current prescription guidelines for each country.

  5. Mean Number of Doses of Palivizumab Administered

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

AbbVie (prior sponsor, Abbott)

Industry

Collaborators

  • Fundasamin (Argentina)

Registry information

Official study title

A One-Year Observational Study of Palivizumab in Infants at Risk for Respiratory Syncytial Virus Infection in Latin America

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 16, 2011
Registry last updated
Oct 1, 2014

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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