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Effect of Palivizumab on Later Recurrent Wheezing in Preterm Infants

NCT01072552 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 444

Last updated 2012-04-03

No results posted yet for this study

Summary

The hypothesis of the present study is that the prophylaxis with palivizumab to prevent the severe RS virus infection during the infancy among preterm infants may reduce the risk of subsequent recurrent wheezing in childhood.

The infants born between July 1st and December 31st in 2007 with the gestational age between 33 and 35 weeks were enrolled into the study at the end of RS virus infection season, April 2008. The infants were unintentionally divided into two groups, either palivizumab treated or untreated group at the enrollment, because the timing for palivizumab prophylaxis were already ended.

The study infants will be followed up until the age of 3 with recording the incidence of either parent reported or physician diagnosed recurrent wheezing.

The difference of the incidence of the recurrent wheezing between the groups will be analyzed with Kaplan-Meier method.

Conditions

  • Recurrent Wheezing
  • Wheezing
  • Asthma

Sponsors & Collaborators

  • Scientific Committee of Recurrent Wheezing

    collaborator NETWORK

  • Satoshi Kusuda

    lead OTHER

Principal Investigators

  • Sankei Nishima, MD · National Fukuoka Hospital

  • Kenji Okada, MD · National Fukuoka Hospital

Eligibility

Min Age
3 Months
Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2010-12-31
Completion
2011-08-31

Countries

  • Japan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01072552 on ClinicalTrials.gov