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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

343 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2014-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atopic Asthma Recurrent Wheezing

Keywords

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atopic asthma recurrent wheezing preterm infants palivizumab respiratory syncytial virus RSV

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Treated

Palivizumab treated

No interventions assigned to this group

Untreated

Palivizumab untreated

No interventions assigned to this group

Eligibility Criteria

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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)

Minimum Eligible Age

3 Years

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Hiroyuki Mochizuki

Professor, Department of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hiroyuki Mochizuki, M.D., Ph.D.,

Role: PRINCIPAL_INVESTIGATOR

Professor, Department of Pediatrics, Tokai University School of Medicine

References

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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.

Reference Type DERIVED

PMID: 28152315 (View on PubMed)

Other Identifiers

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SCELIA study

Identifier Type: -

Identifier Source: org_study_id