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COVID-19 and Lactating Mothers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04558320
Recruitment Status : Completed
First Posted : September 22, 2020
Last Update Posted : November 4, 2021
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
New York University
Information provided by (Responsible Party):
Kirsi Jarvinen-Seppo, University of Rochester

Study Description
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Brief Summary:
The purpose of this study is to determine if there may be COVID-19 virus in various samples collected from mothers and infants.

Condition or disease
Coronavirus Infection

Study Design
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Study Type : Observational
Actual Enrollment : 76 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: COVID-19 and Lactating Mothers
Actual Study Start Date : July 2, 2020
Actual Primary Completion Date : April 1, 2021
Actual Study Completion Date : September 1, 2021

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. mean change in SARS-Cov-2 viral load in breast milk [ Time Frame: baseline, days 3, 10, 19, 28 and 90 ]
    RNA will be extracted from all sample types and SARS-CoV-2 primers used to amplify any present viral RNA using real-time qPCR. Repeated measures analysis will be used to compare the changes in sample viral load over time between women with mild to severe symptoms.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This study will include 50 adult lactating parents with COVID-19, and their infants (total sample size = 100). Participants can be residing anywhere in the continental United States.
Criteria

Inclusion Criteria:

  • Currently lactating mother:

    • English-speaking
    • greater than or equal to 18 years of age
    • Assigned female at birth (AFAB)
    • Having a positive COVID-19 test within 14 days

  • Child:

    • Infants younger than or equal to 6 months of age, exclusively or partially human milk fed, sourced from mother. Infants who are fed both directly at the breast and exclusively fed mother's milk via bottle will be included

Exclusion Criteria:

  • Non-English speaking
Contacts and Locations
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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): NCT04558320


Locations
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United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
National Institute of Allergy and Infectious Diseases (NIAID)
New York University
More Information
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Responsible Party: Kirsi Jarvinen-Seppo, Associate Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT04558320    
Other Study ID Numbers: STUDY00004889
3U01AI131344-04S1 ( U.S. NIH Grant/Contract )
First Posted: September 22, 2020    Key Record Dates
Last Update Posted: November 4, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
 RNA Virus Infections
Virus Diseases
Infections