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

NCT01545245 | Completed

• 1 other identifier: SCELIA study
• Study Type: observational
• Target: 343
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Atopic Asthma; Recurrent Wheezing

Keywords

atopic asthma; recurrent wheezing; preterm infants; palivizumab; respiratory syncytial virus; RSV

Outcome Measures

Primary Outcomes (1)

• 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

  For three years

Secondary Outcomes (1)

• 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

  For three years

Study Arms (2)

Treated

Palivizumab treated

Untreated

Palivizumab untreated

Eligibility Criteria

• Age: 3 Years - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tokai University: lead
• Scientific Committee for Elucidation of Infantile Asthma: collaborator

Related Publications (1)

• Mochizuki H, Kusuda S, Okada K, Yoshihara S, Furuya H, Simoes EAF; Scientific Committee for Elucidation of Infantile Asthma. Palivizumab Prophylaxis in Preterm Infants and Subsequent Recurrent Wheezing. Six-Year Follow-up Study. Am J Respir Crit Care Med. 2017 Jul 1;196(1):29-38. doi: 10.1164/rccm.201609-1812OC.

  PMID: 28152315 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

The serum samples

MeSH Terms

Conditions

Respiratory Sounds

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hiroyuki Mochizuki, M.D., Ph.D.,

  Professor, Department of Pediatrics, Tokai University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Pediatrics

Study Record Dates

• First Submitted: February 29, 2012
• First Posted: March 6, 2012
• Study Start: July 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: December 8, 2014

Record last verified: 2014-12