Exclusive Breastfeeding in Infants of Mothers Infected With Novel Coronavirus

NCT ID: NCT04925908

Last Updated: 2022-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

338 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Covid19 Breastfeeding, Exclusive Newborn Morbidity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Control Group

Infants of mothers with suspected but negative for COVID-19

RT-PCR for SARS-Cov-2

Intervention Type DIAGNOSTIC_TEST

Nasopharyngeal swab for detecting Novel Coronavirus-2 by reverse transcriptase polymerase chain reaction

Case Group

Infants Born to COVID-19 positive mothers

RT-PCR for SARS-Cov-2

Intervention Type DIAGNOSTIC_TEST

Nasopharyngeal swab for detecting Novel Coronavirus-2 by reverse transcriptase polymerase chain reaction

Interventions

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RT-PCR for SARS-Cov-2

Nasopharyngeal swab for detecting Novel Coronavirus-2 by reverse transcriptase polymerase chain reaction

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Maximum Eligible Age

7 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seda Yilmaz Semerci

Neonatologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Kucukcekmece, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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KAEK/2021.05.165

Identifier Type: -

Identifier Source: org_study_id

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