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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Scientific Committee for Elucidation of Infantile Asthma
Information provided by (Responsible Party):
Hiroyuki Mochizuki, Tokai University
ClinicalTrials.gov Identifier:
NCT01545245
First received: February 29, 2012
Last updated: March 5, 2012
Last verified: March 2012
  Purpose

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.


Condition
Atopic Asthma
Recurrent Wheezing

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official 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

Resource links provided by NLM:


Further study details as provided by Tokai University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

The serum samples


Enrollment: 343
Study Start Date: July 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Treated
Palivizumab treated
Untreated
Palivizumab untreated

  Eligibility

Ages Eligible for Study:   3 Years to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The children who are participating in another on-going study, "Effect of Palivizumab on Later Recurrent Wheezing in Preterm Infants (ClinicalTrials.gov Identifier: NCT01072552)" and whose parents or legal guardian provide informed consent in writing for continuing participation in the study.

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01545245

Sponsors and Collaborators
Tokai University
Scientific Committee for Elucidation of Infantile Asthma
Investigators
Principal Investigator: Hiroyuki Mochizuki, M.D., Ph.D., Professor, Department of Pediatrics, Tokai University School of Medicine
  More Information

No publications provided

Responsible Party: Hiroyuki Mochizuki, Professor, Department of Pediatrics, Tokai University
ClinicalTrials.gov Identifier: NCT01545245     History of Changes
Other Study ID Numbers: SCELIA study
Study First Received: February 29, 2012
Last Updated: March 5, 2012
Health Authority: Japan: Institutional Review Board

Keywords provided by Tokai University:
atopic asthma
recurrent wheezing
preterm infants
palivizumab
respiratory syncytial virus
RSV

Additional relevant MeSH terms:
Asthma
Virus Diseases
Respiratory Sounds
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Palivizumab
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014