Effect of Palivizumab on Later Recurrent Wheezing in Preterm Infants

Asthma Clinical Trial

Official title:

Effect of Palivizumab Treatment on Subsequent Recurrent Wheezing in Preterm Infants: Case-control Study by Scientific Committee of Recurrent Wheezing (SCREW)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01072552
• Other study ID #: SCREW-001
• Status: Completed
• Phase: N/A
• First received: December 21, 2009
• Last updated: April 1, 2012
• Start date: March 2008
• Est. completion date: August 2011

Study information

• Verified date: April 2012
• Source: Tokyo Women's Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 444
• Est. completion date: August 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 1 Year

Eligibility

Inclusion Criteria:

• Infants born July ~ December 2007 at 33~35 weeks of gestation

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).

• Infants received less than 3 doses of palivizumab during the first 6 months of life

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma
• Recurrent Wheezing
• Wheezing

Locations

Country	Name	City	State
Japan	Tokyo Women's Medical University	Shinjuku	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Satoshi Kusuda	Scientific Committee of Recurrent Wheezing

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative incidence of recurrent wheezing confirmed by physicians		two years	No
Secondary	Cumulative incidence of recurrent wheezing confirmed by parents		two years	No
Secondary	Incidence of atopic asthma evaluated by SCREW according to the results of the questionnaire and hematological examination		two years	No
Secondary	Cumulative incidence of wheezing confirmed by parents		two years	No
Secondary	Cumulative incidence of wheezing confirmed by physicians		two years	No
Secondary	Number of hospital/clinic visits and hospitalizations due to respiratory-related diseases		two years	No