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Published on: July 27, 2021
Respiratory syncytial virus prevention and asthma in healthy preterm infants: a randomised controlled trial
Nienke M Scheltema1, Elisabeth E Nibbelke1, Juliëtte Pouw2
1Department of Pediatric Infectious Diseases and Immunology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, Netherlands.
Insights
Preventing respiratory syncytial virus (RSV) in infancy did not significantly reduce asthma rates or improve lung function by age 6. Further studies are needed to understand RSV prevention
Area of Science:
- Pediatric pulmonology
- Infectious disease epidemiology
- Clinical trial research
Background:
- Respiratory syncytial virus (RSV) infection in infancy is linked to later wheezing and asthma development.
- Previous research indicated a causal link between RSV prevention in infancy and reduced subsequent wheeze.
- This study extends follow-up to assess long-term effects on asthma and lung function.
Purpose of the Study:
- To evaluate the long-term impact of RSV immunoprophylaxis in preterm infants on asthma development and lung function at age 6.
- To determine if early RSV prevention influences the incidence of current asthma and respiratory health outcomes.
- To analyze parent-reported asthma and objective lung function measurements.
Main Methods:
- A single-blind, randomized, placebo-controlled trial involving 429 infants (32-35 weeks gestation).
- Infants received either palivizumab for RSV immunoprophylaxis or a placebo during their first year.
- Follow-up continued until age 6, assessing parent-reported asthma and spirometry (FEV0.5).
Main Results:
- 92% of participants completed the 6-year follow-up.
- Parent-reported current asthma was lower in the RSV prevention group (14.1%) versus placebo (24.0%), with an absolute risk reduction of 9.9%.
- However, physician-diagnosed asthma and lung function (FEV0.5) were similar between groups at age 6.
Conclusions:
- RSV prevention in otherwise healthy preterm infants did not demonstrate a significant long-term effect on current asthma or lung function at age 6.
- The findings suggest that while RSV prevention may impact early wheezing, its effect on established asthma by school age is limited in this cohort.
- Further research is warranted to explore RSV prevention's role in asthma development in the broader population.
Background:
Respiratory syncytial virus (RSV) infection is associated with subsequent wheeze and asthma. We previously reported on the causal relationship between prevention of RSV infection during infancy and reduced frequency of subsequent wheeze using a double-blind, randomised, placebo-controlled trial (MAKI). We continued follow-up and analysed the effect of RSV prevention during infancy on asthma and lung function at age 6 years.
Methods:
We studied 429 infants born at 32-35 weeks of gestation between 2008-10 who had randomly received either palivizumab for RSV immunoprophylaxis or placebo during the RSV season of their first year of life. After the first year of follow-up, single, assessor-blind follow-up of children continued until they were aged 6 years. Primary outcomes were parent-reported current asthma and forced expiratory volume in 0·5 s (FEV0·5). The trial is registered in the ISRCTN registry, number ISRCTN73641710.
Findings:
395 (92%) of 429 participants completed this 6-year follow-up study. Parent-reported current asthma was reported in 28 (14·1%) of 199 children in the RSV prevention group and 47 (24·0%) of 196 children in the placebo group (absolute risk reduction [ARR] 9·9%, 95% CI 2·2 to 17·6). The difference in current asthma, which was a composite endpoint, was due to a difference in infrequent wheeze (one to three episodes in the past year; 12 [6·0%] of 199 vs 26 [13·4%] of 194, ARR 7·4%, 95% CI 1·5 to 13·2). FEV0·5 percentage predicted values were similar between the RSV prevention group (89·1% [SD 10·6]) and placebo group (90·1% [11·1]), with a mean difference of 1·0 (95% CI -1·3 to 3·3). The proportion of children with current physician-diagnosed asthma was similar between the RSV prevention group (19 [10·3%] of 185) and placebo group (18 [9·9%] of 182), with an ARR of -0·4 (95% CI -6·5 to 5·8).
Interpretation:
In otherwise healthy preterm infants, this single-blind, randomised, placebo-controlled trial showed that RSV prevention did not have a major effect on current asthma or lung function at age 6 years. Future research will inform on the effect of RSV prevention on asthma at school age in the general population.
Funding:
AbbVie.
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