Exclusive Breastfeeding in Infants of Mothers Infected With Novel Coronavirus

November 18, 2022 updated by: Seda Yilmaz Semerci, Kanuni Sultan Suleyman Training and Research Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

338

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Kucukcekmece
      • Istanbul, Kucukcekmece, Turkey, 34303
        • Kanuni Sultan Suleyman Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Infants who were born to mothers with suspected/proven COVID-19

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control Group
Infants of mothers with suspected but negative for COVID-19
Diagnostic test: RT-PCR for SARS-Cov-2
Nasopharyngeal swab for detecting Novel Coronavirus-2 by reverse transcriptase polymerase chain reaction
Case Group
Infants Born to COVID-19 positive mothers
Diagnostic test: RT-PCR for SARS-Cov-2
Nasopharyngeal swab for detecting Novel Coronavirus-2 by reverse transcriptase polymerase chain reaction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exclusive breastfeeding
Time Frame: 6 months
Rate of exclusive breastfeeding
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease status
Time Frame: 6 months
COVID-19 positive/negative
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Actual)

December 12, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

June 8, 2021

First Submitted That Met QC Criteria

June 8, 2021

First Posted (Actual)

June 14, 2021

Study Record Updates

Last Update Posted (Actual)

November 22, 2022

Last Update Submitted That Met QC Criteria

November 18, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KAEK/2021.05.165

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Covid19

Clinical Trials on RT-PCR for SARS-Cov-2

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe