Exclusive Breastfeeding in Infants of Mothers Infected With Novel Coronavirus

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04925908

Collaborator

(none)

260

Enrollment

Location

Anticipated Duration (Months)

37.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Covid19 Breastfeeding, Exclusive Newborn Morbidity	Diagnostic Test: RT-PCR for SARS-Cov-2

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 Design

Study Type:

Observational

Anticipated Enrollment :

260 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

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

Actual Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

Dec 12, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Exclusive breastfeeding [6 months]
Rate of exclusive breastfeeding

Secondary Outcome Measures

Disease status [6 months]
COVID-19 positive/negative

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 7 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kanuni Sultan Suleyman Training and Research Hospital	Istanbul	Kucukcekmece	Turkey	34303

Sponsors and Collaborators

Kanuni Sultan Suleyman Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Seda Yilmaz Semerci, Neonatologist, Kanuni Sultan Suleyman Training and Research Hospital

ClinicalTrials.gov Identifier:

NCT04925908

Other Study ID Numbers:

KAEK/2021.05.165

First Posted:

Jun 14, 2021

Last Update Posted:

Jun 24, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Coronavirus Infections

Study Results

No Results Posted as of Jun 24, 2021