Effects of Preventive Treatment for Respiratory Syncytial (RS) Virus Infection During Infancy on Later Atopic Asthma in Preterm Infants

The primary objective of the study is to determine whether the incidence of atopic asthma after three years old may be suppressed in the children who were born as preterm infants and prophylactically treated with palivizumab for respiratory syncytial (RS) virus infections during the infancy.

The secondary objective is to determine whether the incidence of recurrent wheezing after three years old may be suppressed in the children who were born as preterm infants and prophylactically treated with palivizumab for RS virus infections during the infancy.

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Key information

Conditions

Atopic Asthma Pathological Conditions, Signs and Symptoms Recurrent Wheezing Respiratory Sounds Signs and Symptoms Signs and Symptoms, Respiratory

Age range

3 year–3 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Infants born July ~ December 2007 at 33~35 weeks of gestation
Infants administered at least 3 doses of palivizumab during the first 6 months of life (Palivizumab treated)
Infants not administered any doses of palivizumab during the first 6 months of life (Palivizumab untreated)

Exclusion criteria

Intrauterine growth retardation (less than -2.5SD)
Infants with chronic lung disease (CLD) or other respiratory disease
Infants received mechanical ventilation
Infants with chronic heart disease (CHD) or congenital anomaly (such as immunodeficiency)

Treatment and study plan

Primary outcomes

The incidence of atopic asthma after three years old in the children who were born as preterm infants and prophylactically treated with palivizumab for RS virus infections during the infancy

Time frame: For three years

Secondary outcomes

The incidence of recurrent wheezing after three years old in the children who were born as preterm infants and prophylactically treated with palivizumab for RS virus infections during the infancy

Time frame: For three years

Sponsors and collaborators

Lead sponsor

Tokai University

Other

Collaborators

Scientific Committee for Elucidation of Infantile Asthma

Registry information

Official study title

Cohort Study to Evaluate Effects of Prophylactic Treatment for Respiratory Syncytial (RS) Virus Infection in Respiratory Tract During Infancy on Subsequent Atopic Asthma in Preterm Infants

Important dates

Study start: 2010
Primary completion: 2014
Study completion: 2014
First posted: Mar 6, 2012
Registry last updated: Dec 8, 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.

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

Completed