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Completed

NCT Number: NCT01072552

Effect of Palivizumab on Later Recurrent Wheezing in Preterm Infants

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.

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Key information

Conditions

Recurrent Wheezing Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathological Conditions, Signs and Symptoms Respiratory Hypersensitivity Respiratory Sounds Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Wheezing

Age range

3 month–1 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tokyo Women's Medical University

Shinjuku, Tokyo, 1628666, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Cumulative incidence of recurrent wheezing confirmed by physicians

    Time frame: two years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Satoshi Kusuda

Other

Collaborators

  • Scientific Committee of Recurrent Wheezing

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Feb 22, 2010
Registry last updated
Apr 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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