Effect of Palivizumab on Later Recurrent Wheezing in Preterm Infants

This study has been completed.
Sponsor:
Collaborator:
Scientific Committee of Recurrent Wheezing
Information provided by (Responsible Party):
Satoshi Kusuda, Tokyo Women's Medical University
ClinicalTrials.gov Identifier:
NCT01072552
First received: December 21, 2009
Last updated: April 1, 2012
Last verified: April 2012
  Purpose

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.


Condition
Recurrent Wheezing
Wheezing
Asthma

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effect of Palivizumab Treatment on Subsequent Recurrent Wheezing in Preterm Infants: Case-control Study by Scientific Committee of Recurrent Wheezing (SCREW)

Resource links provided by NLM:


Further study details as provided by Tokyo Women's Medical University:

Primary Outcome Measures:
  • Cumulative incidence of recurrent wheezing confirmed by physicians [ Time Frame: two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cumulative incidence of recurrent wheezing confirmed by parents [ Time Frame: two years ] [ Designated as safety issue: No ]
  • Incidence of atopic asthma evaluated by SCREW according to the results of the questionnaire and hematological examination [ Time Frame: two years ] [ Designated as safety issue: No ]
  • Cumulative incidence of wheezing confirmed by parents [ Time Frame: two years ] [ Designated as safety issue: No ]
  • Cumulative incidence of wheezing confirmed by physicians [ Time Frame: two years ] [ Designated as safety issue: No ]
  • Number of hospital/clinic visits and hospitalizations due to respiratory-related diseases [ Time Frame: two years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

serum


Enrollment: 444
Study Start Date: March 2008
Study Completion Date: August 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Treated
Palivizumab treated
Untreated
Palivizumab untreated

  Eligibility

Ages Eligible for Study:   3 Months to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Infants with the gestational age between 33 and 35 weeks

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01072552

Locations
Japan
Tokyo Women's Medical University
Shinjuku, Tokyo, Japan, 1628666
Sponsors and Collaborators
Satoshi Kusuda
Scientific Committee of Recurrent Wheezing
Investigators
Study Director: Sankei Nishima, MD National Fukuoka Hospital
Principal Investigator: Kenji Okada, MD National Fukuoka Hospital
  More Information

Additional Information:
No publications provided by Tokyo Women's Medical University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Satoshi Kusuda, Professor of Neonatology, Tokyo Women's Medical University
ClinicalTrials.gov Identifier: NCT01072552     History of Changes
Other Study ID Numbers: SCREW-001
Study First Received: December 21, 2009
Last Updated: April 1, 2012
Health Authority: Japan: Institutional Review Board

Keywords provided by Tokyo Women's Medical University:
recurrent wheezing
asthma
preterm infants
palivizumab
atopic diseases

Additional relevant MeSH terms:
Palivizumab
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014