The Long-term Effect of RSV Infection

NCT03876249 | Unknown

• 1 other identifier: CHRF001
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma in Children

Outcome Measures

Primary Outcomes (1)

• Asthma among the 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

  at the age of 6-7 years of the enrolled children

Secondary Outcomes (4)

• Maximum forced expiratory air volume in one second (FEV1)

  at the age of 6-7 years of the children

• Hyperreactivity against allergens

  at the age of 6-7 years of the children

• Height of the children

  at the age of 6-7 years of the children

• Weight of the children

  at the age of 6-7 years of the children

Study Arms (2)

RSV positive group

Children who had RSV infection within the first 60 days of life

Other: exposure to RSV

RSV negative group

Children without known RSV infection within the first 60 days of life

Other: exposure to RSV

Interventions

exposure to RSV OTHER

No intervention will be given, children naturally exposed to RSV in their early life

RSV negative group; RSV positive group

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Child Health Research Foundation, Bangladesh: lead
• University of Edinburgh: collaborator
• Aga Khan University: collaborator
• Projahnmo Research Foundation: collaborator
• Asian Institute of Public Health: collaborator
• KEM Hospital Research Centre: collaborator
• Maternal, Neonatal and Child Health Research Network: collaborator

Related Publications (12)

• Balfour-Lynn IM. Why do viruses make infants wheeze? Arch Dis Child. 1996 Mar;74(3):251-9. doi: 10.1136/adc.74.3.251. No abstract available.

  PMID: 8787436 RESULT

• Bisgaard H, Szefler S. Prevalence of asthma-like symptoms in young children. Pediatr Pulmonol. 2007 Aug;42(8):723-8. doi: 10.1002/ppul.20644.

  PMID: 17598172 RESULT

• Castleman WL, Sorkness RL, Lemanske RF, Grasee G, Suyemoto MM. Neonatal viral bronchiolitis and pneumonia induces bronchiolar hypoplasia and alveolar dysplasia in rats. Lab Invest. 1988 Sep;59(3):387-96.

  PMID: 3411939 RESULT

• Jat KR, Kabra SK. Wheezing in children with viral infection & its long-term effects. Indian J Med Res. 2017 Feb;145(2):161-162. doi: 10.4103/ijmr.IJMR_1459_16. No abstract available.

  PMID: 28639590 RESULT

• Kneyber MCJ, Steyerberg EW, de Groot R, Moll HA. Long-term effects of respiratory syncytial virus (RSV) bronchiolitis in infants and young children: a quantitative review. Acta Paediatr. 2000 Jun;89(6):654-60. doi: 10.1080/080352500750043945.

  PMID: 10914957 RESULT

• Leung R, Ho P. Asthma, allergy, and atopy in three south-east Asian populations. Thorax. 1994 Dec;49(12):1205-10. doi: 10.1136/thx.49.12.1205.

  PMID: 7878553 RESULT

• Sigurs N, Aljassim F, Kjellman B, Robinson PD, Sigurbergsson F, Bjarnason R, Gustafsson PM. Asthma and allergy patterns over 18 years after severe RSV bronchiolitis in the first year of life. Thorax. 2010 Dec;65(12):1045-52. doi: 10.1136/thx.2009.121582. Epub 2010 Jun 27.

  PMID: 20581410 RESULT

• 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.

  RESULT

• Subbarao P, Mandhane PJ, Sears MR. Asthma: epidemiology, etiology and risk factors. CMAJ. 2009 Oct 27;181(9):E181-90. doi: 10.1503/cmaj.080612. Epub 2009 Sep 14. No abstract available.

  PMID: 19752106 RESULT

• Svanes C, Sunyer J, Plana E, Dharmage S, Heinrich J, Jarvis D, de Marco R, Norback D, Raherison C, Villani S, Wjst M, Svanes K, Anto JM. Early life origins of chronic obstructive pulmonary disease. Thorax. 2010 Jan;65(1):14-20. doi: 10.1136/thx.2008.112136. Epub 2009 Sep 2.

  PMID: 19729360 RESULT

• 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 Lazaro 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-Baccala 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.

  PMID: 28689664 RESULT

• Wu P, Hartert TV. Evidence for a causal relationship between respiratory syncytial virus infection and asthma. Expert Rev Anti Infect Ther. 2011 Sep;9(9):731-45. doi: 10.1586/eri.11.92.

  PMID: 21905783 RESULT

Central Study Contacts

Samir K Saha, PhD

CONTACT

00880 2 9104211; samir@chrfbd.org

Mohammad S Islam, MSPH

CONTACT

00880 2 9104211; shahidul@chrfbd.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2019
• First Posted: March 15, 2019
• Study Start: June 1, 2019
• Primary Completion: August 30, 2020
• Study Completion: December 30, 2020
• Last Updated: March 15, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share