Community-based RSV Surveillance in Infant Mortality: Minimally Invasive Tissue Sampling Study in Karachi, Pakistan

NCT05047549 | Unknown

• 1 other identifier: 2020-3675-10613
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

In order to assess the burden of respiratory syncytial virus on infant mortality in Pakistan, nasopharyngeal swab sampling and minimally invasive tissue sampling (MITS) will be conducted on deceased infants under 6 months of age. The specimens will be analysed by the microbiology and histopathology labs at Aga Khan University, Karachi, Pakistan. Verbal consent will be obtained from parents of deceased infants, and a cause of death lab report and grief counseling services will be offered to enrolled parents who gave consent for specimen collection. The study is funded by Bill \& Melinda Gates Foundation in affiliation with Research Triangle Institute (RTI) MITS Surveillance Alliance.

Conditions

Respiratory Syncytial Virus (RSV); Infant Death; Community-Acquired Infections

Keywords

respiratory syncytial virus; infant mortality; minimally invasive tissue sampling

Outcome Measures

Primary Outcomes (3)

• RSV nasopharyngeal swab

  A special swab will be use to take a sample from the nose or throat and Reverse transcription-Polymerase chain reaction (RT-PCR) will be done to understand the burden of disease in deceased children under 6 months of age from a real time community setting.

  2 months

• RSV lung/thorax microbiology

  lung fluid will be aspirated and Reverse transcription-Polymerase chain reaction (RT-PCR) will be done to assess the burden of RSV in deceased infants under 6 months of age.

  2 months

• RSV lung/thorax histopathology

  Minimally invasive tissue sampling (MITS) will be performed to obtain lung tissue specimens Tissues will be examined through histopathology. Through the sample collection we will understand the burden of RSV among deceased infants, as well as cause of death due to upper respiratory tract infection.

  2 months

Eligibility Criteria

• Age: 1 Minute - 6 Months
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Deceased neonates and infants (under 6 months of age) born and died within specified catchment areas

You may qualify if:

• Parents, caregivers of deceased infants (under 6 months of age)
• Residing in one of 2 catchment areas in Karachi, enrolled in Demographic Surveillance System
• Have given informed verbal consent for collection of nasopharyngeal specimen AND lung/thorax tissue sampling

You may not qualify if:

• Miscarriages (under 28 gestational weeks)
• Known stillbirths
• Guest/visiting families in the area that will not be participating in verbal autopsy after infant death

Sponsors & Collaborators

• Aga Khan University: lead
• RTI International: collaborator
• Bill and Melinda Gates Foundation: collaborator
• Yale University: collaborator

Study Sites (1)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

RECRUITING

MeSH Terms

Conditions

Infant Death; Community-Acquired Infections

Condition Hierarchy (Ancestors)

Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: September 17, 2021
• Study Start: November 2, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: September 17, 2021

Record last verified: 2021-09

Locations

PA (1)