Effect of Palivizumab on Later Recurrent Wheezing in Preterm Infants

NCT01072552 | Completed DMC

• 1 other identifier: SCREW-001
• Study Type: observational
• Target: 444
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Wheezing; Wheezing; Asthma

Keywords

recurrent wheezing; asthma; preterm infants; palivizumab; atopic diseases

Outcome Measures

Primary Outcomes (1)

• Cumulative incidence of recurrent wheezing confirmed by physicians

  two years

Secondary Outcomes (5)

• Cumulative incidence of recurrent wheezing confirmed by parents

  two years

• Incidence of atopic asthma evaluated by SCREW according to the results of the questionnaire and hematological examination

  two years

• Cumulative incidence of wheezing confirmed by parents

  two years

• Cumulative incidence of wheezing confirmed by physicians

  two years

• Number of hospital/clinic visits and hospitalizations due to respiratory-related diseases

  two years

Study Arms (2)

Treated

Palivizumab treated

Untreated

Palivizumab untreated

Eligibility Criteria

• Age: 3 Months - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants with the gestational age between 33 and 35 weeks

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Satoshi Kusuda: lead
• Scientific Committee of Recurrent Wheezing: collaborator

Study Sites (1)

Tokyo Women's Medical University

Shinjuku, Tokyo, 1628666, Japan

Location

Related Publications (1)

• Yoshihara S, Kusuda S, Mochizuki H, Okada K, Nishima S, Simoes EA; C-CREW Investigators. Effect of palivizumab prophylaxis on subsequent recurrent wheezing in preterm infants. Pediatrics. 2013 Nov;132(5):811-8. doi: 10.1542/peds.2013-0982. Epub 2013 Oct 14.

  PMID: 24127479 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Respiratory Sounds; Asthma

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Sankei Nishima, MD

  National Fukuoka Hospital

  STUDY DIRECTOR

• Kenji Okada, MD

  National Fukuoka Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Neonatology

Study Record Dates

• First Submitted: December 21, 2009
• First Posted: February 22, 2010
• Study Start: March 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: August 1, 2011
• Last Updated: April 3, 2012

Record last verified: 2012-04

Locations

JP (1)