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Clinical Trials/NCT03876249
NCT03876249UnknownNot Applicable

The Consequence of Respiratory Syncytial Virus (RSV) Infection in Young Infants

Child Health Research Foundation, Bangladesh0 sites2,000 target enrollmentStarted: June 1, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
2,000
Primary Endpoint
Asthma among the children

Study Overview

Brief Summary

Respiratory Syncytial Virus (RSV) is a leading cause of childhood illness and hospitalization across the world. In addition to acute mortality and morbidity, RSV infection is associated with developing recurrent wheeze in pre-school children and asthma in later life. The overarching aim of the study is to demonstrate the long-term effect of RSV infection on child health in resource-poor settings.

Children previously infected with RSV in their first two months of life and age-matched controls will be followed and epidemiological data will be compared in terms of prevalence of asthma, lung function status, physical growth status, and asthma risk factors. Enrolled children will be routinely assessed for a period of 12 months. During this period, this study will record the health status of the children (respiratory tract illness, wheeze, cough, other illness, and attendance at medical services), physical growth (height, weight and mid-upper arm circumference), family history of atopic diseases (e.g. asthma) and environmental risk exposure (indoor tobacco smoke, crowding, and cooking fuels, cooking place) among enrolled children. Where the acute asthma exacerbation will be suspected, physicians will assess the lung condition of the enrolled sick children using stethoscope and peak flow-meter. The lung function of children will be measured using spirometry, hyper-reactivity against common allergens will be performed using skin prick methods, exercise challenge test will be performed to understand the airway hyperresponsiveness, and blood eosinophil count determine the eosinophil level in the peripheral blood.

Detailed Description

Background: Respiratory syncytial virus (RSV) is the most common cause of childhood illness which attack the lower respiratory tract and develop bronchitis and pneumonia. Approximately 70% of infants are infected with RSV during their first year of life, and almost all children are infected at least once by 2 years of age (Wu & Hartert, 2011).

Each year, an estimated 33·1 million episodes of RSV-associated acute lower respiratory infections occur among under-five children globally, leading to 3·2 million hospitalizations and 118,200 deaths (Ting Shi & Acacio, 2017). The burden of RSV-associated severe acute lower respiratory tract infection is 10 times higher in developing countries compared to that in developed countries (36.1 per 1000 life birth vs 3.2 per 1000 life birth, respectively).

In addition to acute mortality and morbidity, RSV infection has a long-term effect on children's health (Jat & Kabra, 2017; Kneyber, Steyerberg, de Groot, & Moll, 2000). RSV infection can induce a state of bronchial hyper-reactivity that has an association with the development of asthma in later life (Balfour-Lynn, 1996), which, in turn, is a major risk factor of chronic obstructive pulmonary disease in adulthood (Svanes et al., 2010).. The prevalence of wheezing and asthma were reported two times higher in the children who had RSV bronchitis in infancy compared with children without a history of bronchiolitis during infancy (Sigurs et al., 2010). In a report, it was shown that among the children who experienced asthma by school age, 31% of them had healthcare visits in infancy due to respiratory diseases (Wu & Hartert, 2011). The severity of the RSV associated illness was reported as an additive factor for asthma risk. Hartert et, al., reported that asthma prevalence was two times higher in the infants who were hospitalized for RSV infection compared to the other who received care at the outdoor department (Wu & Hartert, 2011). In the mouse model, it was found that viral infection in neonatal rats delayed the growth of secondary septa, decreased the alveolar surface density by 14 to 26%, and reduced the diameter of terminal bronchioles by 11 and 20% (Castleman, Sorkness, Lemanske, Grasee, & Suyemoto, 1988). However, there is no data on the effect of RSV infection on the lung of neonates. In human, the lung remains premature at birth and continue to develop for 2-3 years postnatally and can be assumed that the impact of RSV infection during early infancy would be very severe.

Collecting clinical samples from young infants and lack of appropriate diagnostic to detect RSV virus are the major obstacles to study RSV infection in developing countries. No study from developing countries has investigated the long-term effect of RSV infections incurred during the young infant period. It is assumed that the long-term effect of RSV infection might be more intense if infection occurs during this period, as the lungs of newborns continue to develop for the first several months of life.

Recently, a study aimed to determine the etiology of young infant infection at five centers of three South Asian countries (Bangladesh, India, and Pakistan). This study identified 474 young infants who had laboratory-confirmed RSV infection; additionally, this study tested specimens from 1,873 age and sex-matched healthy infants, which were found to be negative for RSV. The current age of that cohort is between 5 and 7 years, which provides a unique opportunity to gather information on the long-term effect of RSV infection in a large number of laboratory-confirmed cases at a low cost.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
5 Years to 7 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Child was enrolled in the ANISA study
  • Child had RSV infection in the first two months of life Non-RSV group
  • Child was enrolled in the ANISA study
  • Child provided respirator samples in the first two months of life
  • Child was illness-free during the first two months of life
  • RSV was not detected in the respiratory samples

Exclusion Criteria

  • Caregiver of the child is unwilling to participate in the study

Outcomes

Primary Outcomes

Asthma among the children

Time Frame: at the age of 6-7 years of the enrolled children

Caregiver reported three or more episodes of wheezing in the past 12 months OR One or more episode of wheeze and repeated cough during the night when the child did not have a cold or chest infection

Secondary Outcomes

  • Weight of the children(at the age of 6-7 years of the children)
  • Maximum forced expiratory air volume in one second (FEV1)(at the age of 6-7 years of the children)
  • Height of the children(at the age of 6-7 years of the children)
  • Hyperreactivity against allergens(at the age of 6-7 years of the children)

Investigators

Sponsor
Child Health Research Foundation, Bangladesh
Sponsor Class
Other
Responsible Party
Sponsor

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