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The Long-term Effect of RSV Infection

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ClinicalTrials.gov Identifier: NCT03876249
Recruitment Status : Not yet recruiting
First Posted : March 15, 2019
Last Update Posted : March 15, 2019
Sponsor:
Collaborators:
The University of Edinburgh
Aga Khan University
Projahnmo Research Foundation
Asian Institute of Public Health
KEM Hospital Research Centre
Maternal, Neonatal and Child Health Research Network
Information provided by (Responsible Party):
Child Health Research Foundation, Bangladesh

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.


Condition or disease Intervention/treatment
Asthma in Children Other: exposure to RSV

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Consequence of Respiratory Syncytial Virus (RSV) Infection in Young Infants
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
RSV positive group
Children who had RSV infection within the first 60 days of life
Other: exposure to RSV
No intervention will be given, children naturally exposed to RSV in their early life

RSV negative group
Children without known RSV infection within the first 60 days of life
Other: exposure to RSV
No intervention will be given, children naturally exposed to RSV in their early life




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Maximum forced expiratory air volume in one second (FEV1) [ Time Frame: at the age of 6-7 years of the children ]
    Lung function of the enrolled children will be measured using spirometry. Maximum forced expiratory air volume in one second will be reported

  2. Hyperreactivity against allergens [ Time Frame: at the age of 6-7 years of the children ]
    Skin prick test will be perform against common allergens to measure the hyperreactivity of the skin against those allergens

  3. Height of the children [ Time Frame: at the age of 6-7 years of the children ]
    Height of the children in meter

  4. Weight of the children [ Time Frame: at the age of 6-7 years of the children ]
    Weight of the children in Kilogram



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Ages Eligible for Study:   5 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Between 2011 and 2015, ANISA study team members enrolled 56,987 newborns in four study sites. All the suspected sick infants were referred to the health facilities where study physicians assessed the infants using the criteria of possible serious bacterial. Infants who were identified as sick were advised to provide respiratory samples (oropharyngeal and nasopharyngeal swabs). Total 6,394 respiratory samples were collected from 5,350 ill infants, 433 infants were positive for RSV. Additionally, ANISA study team collected respiratory specimens from 1587 age and sex-matched healthy children who did not have any clinical sign of illness at the time of specimens collected and were also remain apparently healthy during both seven days prior to and seven days following sample collection. All these children are eligible to enroll in this study.
Criteria

Inclusion Criteria:

RSV group

  • 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03876249


Contacts
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Contact: Samir K Saha, PhD 00880 2 9104211 ext 171 samir@chrfbd.org
Contact: Mohammad S Islam, MSPH 00880 2 9104211 ext 171 shahidul@chrfbd.org

Sponsors and Collaborators
Child Health Research Foundation, Bangladesh
The University of Edinburgh
Aga Khan University
Projahnmo Research Foundation
Asian Institute of Public Health
KEM Hospital Research Centre
Maternal, Neonatal and Child Health Research Network

Publications of Results:
Siti Nadzrah Y, Zulkiflee AB, and Prepageran N. Common Aeroallergens by Skin Prick Test among the Population in Two Different Regions.Primary Healthcare 5: 206, 2015.
Shi T, McAllister DA, O'Brien KL, Simoes EAF, Madhi SA, Gessner BD, Polack FP, Balsells E, Acacio S, Aguayo C, Alassani I, Ali A, Antonio M, Awasthi S, Awori JO, Azziz-Baumgartner E, Baggett HC, Baillie VL, Balmaseda A, Barahona A, Basnet S, Bassat Q, Basualdo W, Bigogo G, Bont L, Breiman RF, Brooks WA, Broor S, Bruce N, Bruden D, Buchy P, Campbell S, Carosone-Link P, Chadha M, Chipeta J, Chou M, Clara W, Cohen C, de Cuellar E, Dang DA, Dash-Yandag B, Deloria-Knoll M, Dherani M, Eap T, Ebruke BE, Echavarria M, de Freitas Lázaro Emediato CC, Fasce RA, Feikin DR, Feng L, Gentile A, Gordon A, Goswami D, Goyet S, Groome M, Halasa N, Hirve S, Homaira N, Howie SRC, Jara J, Jroundi I, Kartasasmita CB, Khuri-Bulos N, Kotloff KL, Krishnan A, Libster R, Lopez O, Lucero MG, Lucion F, Lupisan SP, Marcone DN, McCracken JP, Mejia M, Moisi JC, Montgomery JM, Moore DP, Moraleda C, Moyes J, Munywoki P, Mutyara K, Nicol MP, Nokes DJ, Nymadawa P, da Costa Oliveira MT, Oshitani H, Pandey N, Paranhos-Baccalà G, Phillips LN, Picot VS, Rahman M, Rakoto-Andrianarivelo M, Rasmussen ZA, Rath BA, Robinson A, Romero C, Russomando G, Salimi V, Sawatwong P, Scheltema N, Schweiger B, Scott JAG, Seidenberg P, Shen K, Singleton R, Sotomayor V, Strand TA, Sutanto A, Sylla M, Tapia MD, Thamthitiwat S, Thomas ED, Tokarz R, Turner C, Venter M, Waicharoen S, Wang J, Watthanaworawit W, Yoshida LM, Yu H, Zar HJ, Campbell H, Nair H; RSV Global Epidemiology Network. Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in young children in 2015: a systematic review and modelling study. Lancet. 2017 Sep 2;390(10098):946-958. doi: 10.1016/S0140-6736(17)30938-8. Epub 2017 Jul 7. Review.

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Responsible Party: Child Health Research Foundation, Bangladesh
ClinicalTrials.gov Identifier: NCT03876249     History of Changes
Other Study ID Numbers: CHRF001
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The personal information will be codified and the linkage data will not share with any other organization

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No