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Completed

NCT Number: NCT00192439

Study to Evaluate the Human Infection of the Lower Respiratory Tract in Children at High Risk

- Estimate the incidence rate of hMPV infection detected by RT-PCR from frozen nasal wash aspirates in children at high risk for severe LRI disease (hospitalized at <2 years of age).

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Key information

Age range

1 day–24 month

Sex eligibility

All sexes

Study type

Observational

Primary location

University Dept. of Paediatrics, Women's and Children's Hospital, North Adelaide, South Australia, Australia

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About this study

  • A prospective, epdemiological study to estimate the incidence rate of hMPV infection as determined by RT-PCR from frozen nasal wash aspirates taken from children hospitalized with LRI who are at high risk for severe disease.
  • No study drug will be administered for this study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Be premature (less than 36 weeks gestation) and less than or equal to 12 months of age, and/or
  • Be less than or equal to 24 months of age with CHD (other than uncomplicated small atrial or ventricular septal defects or patent ductus arteriosus) that is judged to be hemodynamically significant, and/or
  • Be less than or equal to 24 months of age with CLD of prematurity (BPD) requiring medical intervention/management (i.e., supplemental oxygen, steroids, bronchodilators, or diuretics within the previous 6 months).
  • Hospital admission diagnosis referable to an acute lower respiratory tract infection or cardio/respiratory illness with a presumed respiratory infection (e.g., bronchiolitis, bronchitis, or pneumonia or cardiac decompensation associated with respiratory infection); admission must occur between October 1 and June 30 for northern hemisphere sites, and between March 1 and November 30 for southern hemisphere sites.
  • Study enrollment within 2 days after hospitalization.
  • Admission from the community to the Pediatric ward, Neonatal Intensive Care Unit, or the Intensive Care Unit.
  • Have written informed consent obtained from the parent or legal guardian prior to study entry.

Exclusion criteria

  • Known HIV infection or a mother with known HIV infection.

Treatment and study plan

High Risk Respiratory Disease

Behavioral

Sponsors and collaborators

Lead sponsor

MedImmune LLC

Industry

Registry information

Official study title

A Study to Describe the Incidence Rate and Clinical Features of Human Meta Pneumovirus (hMPV) Infection of the Lower Respiratory Tract in Hospitalized Children at High Risk for Severe Disease

Important dates

Study start
2003
Study completion
2006
First posted
Sep 19, 2005
Registry last updated
May 7, 2007

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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