Clinical trial NCT01072552: Effect of Palivizumab on Later Recurrent Wheezing in Preterm Infants
Official title: Effect of Palivizumab Treatment on Subsequent Recurrent Wheezing in Preterm Infants: Case-control Study by Scientific Committee of Recurrent Wheezing (SCREW)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent Wheezing
Wheezing
Asthma
Keywords: recurrent wheezing
asthma
preterm infants
palivizumab
atopic diseases
Lead sponsor: Tokyo Women's Medical University
Sponsor class: OTHER
Collaborators: name: Scientific Committee of Recurrent Wheezing
First posted: 2010-02-22
Enrollment: 444
Sex: ALL
Minimum age (years): 3
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants with the gestational age between 33 and 35 weeks

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.


Eligibility 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

Primary outcomes:
measure: Cumulative incidence of recurrent wheezing confirmed by physicians
timeFrame: two years
Secondary outcomes:
measure: Cumulative incidence of recurrent wheezing confirmed by parents
timeFrame: two years
measure: Incidence of atopic asthma evaluated by SCREW according to the results of the questionnaire and hematological examination
timeFrame: two years
measure: Cumulative incidence of wheezing confirmed by parents
timeFrame: two years
measure: Cumulative incidence of wheezing confirmed by physicians
timeFrame: two years
measure: Number of hospital/clinic visits and hospitalizations due to respiratory-related diseases
timeFrame: two years
Other outcomes:
Locations:
city: Shinjuku
country: Japan
facility: Tokyo Women's Medical University
state: Tokyo
Study officials:
affiliation: National Fukuoka Hospital
name: Sankei Nishima, MD
role: STUDY_DIRECTOR
affiliation: National Fukuoka Hospital
name: Kenji Okada, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.