CompletedNot Applicable

Effects of Preventive Treatment for Respiratory Syncytial (RS) Virus Infection During Infancy on Later Atopic Asthma in Preterm Infants

343 participantsStarted 2010-07

Plain-language summary

The primary objective of the study is to determine whether the incidence of atopic asthma after three years old may be suppressed in the children who were born as preterm infants and prophylactically treated with palivizumab for respiratory syncytial (RS) virus infections during the infancy. The secondary objective is to determine whether the incidence of recurrent wheezing after three years old may be suppressed in the children who were born as preterm infants and prophylactically treated with palivizumab for RS virus infections during the infancy.

Who can participate

Age range

3 Years – 3 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Infants born July \~ December 2007 at 33\~35 weeks of gestation * Infants administered at least 3 doses of palivizumab during the first 6 months of life (Palivizumab treated) * Infants not administered any doses of palivizumab during the first 6 months of life (Palivizumab untreated) 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The incidence of atopic asthma after three years old in the children who were born as preterm infants and prophylactically treated with palivizumab for RS virus infections during the infancy

Timeframe: For three years

Trial details

NCT IDNCT01545245

SponsorTokai University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2014-01

View on ClinicalTrials.gov More Atopic Asthma trials