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Effect of Palivizumab on Later Recurrent Wheezing in Preterm Infants

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ClinicalTrials.gov Identifier: NCT01072552
Recruitment Status : Completed
First Posted : February 22, 2010
Last Update Posted : April 3, 2012
Sponsor:
Collaborator:
Scientific Committee of Recurrent Wheezing
Information provided by (Responsible Party):
Satoshi Kusuda, Tokyo Women's Medical University

Brief 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.


Condition or disease
Recurrent Wheezing Wheezing Asthma

Study Type : Observational
Actual Enrollment : 444 participants
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)
Study Start Date : March 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Palivizumab

Group/Cohort
Treated
Palivizumab treated
Untreated
Palivizumab untreated



Primary Outcome Measures :
  1. Cumulative incidence of recurrent wheezing confirmed by physicians [ Time Frame: two years ]

Secondary Outcome Measures :
  1. Cumulative incidence of recurrent wheezing confirmed by parents [ Time Frame: two years ]
  2. Incidence of atopic asthma evaluated by SCREW according to the results of the questionnaire and hematological examination [ Time Frame: two years ]
  3. Cumulative incidence of wheezing confirmed by parents [ Time Frame: two years ]
  4. Cumulative incidence of wheezing confirmed by physicians [ Time Frame: two years ]
  5. Number of hospital/clinic visits and hospitalizations due to respiratory-related diseases [ Time Frame: two years ]

Biospecimen Retention:   Samples Without DNA
serum


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Ages Eligible for Study:   3 Months to 1 Year   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: February 22, 2010    Key Record Dates
Last Update Posted: April 3, 2012
Last Verified: April 2012

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

Additional relevant MeSH terms:
Respiratory Sounds
Signs and Symptoms, Respiratory
Signs and Symptoms
Palivizumab
Antiviral Agents
Anti-Infective Agents