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NCT04925908 Clinical Trial

Exclusive Breastfeeding in Infants of Mothers Infected With Novel Coronavirus

Covid19 Clinical Trial

Official title:
Evaluation of Exclusive Breastfeeding Within the First Six Months in Infants of Mothers Infected With Novel Coronavirus: 1-year Experience of a Single Center

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04925908
Other study ID # KAEK/2021.05.165
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2021
Est. completion date December 31, 2021

Study information
Verified date November 2022
Source Kanuni Sultan Suleyman Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

COVID-19 pandemic emerges an issue for breastfeeding.Earlier in pandemic mothers who had COVID-19 were separated from their babies due to insufficient data but this approach was abandoned due to the lack of transmission via breastmilk.However, where mothers with COVID-19 are cohorted in the same room, they still have to be isolated from their babies following the birth.Investigators aimed to evaluate rate of exclusive breastfeeding(EB) within first 6 months among mothers who were isolated from their babies due to COVID-19.

Description:

COVID-19 pandemic emerges an issue for breastfeeding.Earlier in pandemic mothers who had COVID-19 were separated from their babies due to insufficient data but this approach was abandoned due to the lack of transmission via breastmilk.However, where mothers with COVID-19 are cohorted in the same room, they still have to be isolated from their babies following the birth.To our knowledge, there is no study regarding this subject to-date.Therefore, investigators aimed to evaluate rate of exclusive breastfeeding(EB) within first 6 months among mothers who were isolated from their babies due to COVID-19.

Recruitment information / eligibility
Status Completed
Enrollment 338
Est. completion date December 31, 2021
Est. primary completion date December 12, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 7 Months
Eligibility Inclusion Criteria: - Infants who were born to mothers with suspected or evident COVID-19 - Accepted to participate with an informed consent of parents Exclusion Criteria: - Congenital abnormalities - Chromosomal abnormalities - Contraindication for breastfeeding - Declined to participate

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• RT-PCR for SARS-Cov-2
Nasopharyngeal swab for detecting Novel Coronavirus-2 by reverse transcriptase polymerase chain reaction

Locations
Country Name City State
Turkey Kanuni Sultan Suleyman Training and Research Hospital Istanbul Kucukcekmece

Sponsors (1)
Lead Sponsor Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Exclusive breastfeeding Rate of exclusive breastfeeding 6 months
Secondary Disease status COVID-19 positive/negative 6 months
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