Clinical trial NCT01545245: Effects of Preventive Treatment for Respiratory Syncytial (RS) Virus Infection During Infancy on Later Atopic Asthma in Preterm Infants
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atopic Asthma
Recurrent Wheezing
Keywords: atopic asthma
recurrent wheezing
preterm infants
palivizumab
respiratory syncytial virus
RSV
Lead sponsor: Tokai University
Sponsor class: OTHER
Collaborators: name: Scientific Committee for Elucidation of Infantile Asthma
First posted: 2012-03-06
Enrollment: 343
Sex: ALL
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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)

Primary outcomes:
measure: 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
timeFrame: For three years
Secondary outcomes:
measure: 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
timeFrame: For three years
Other outcomes:
Locations:
Study officials:
affiliation: Professor, Department of Pediatrics, Tokai University School of Medicine
name: Hiroyuki Mochizuki, M.D., Ph.D.,
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.