Exclusive Breastfeeding in Infants of Mothers Infected Wi... | NCT04925908

Studies
Exclusive Breastfeeding in Infants of Mothers Infected With Novel Coronavirus

NCT04925908

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Status

Completed

Last Update Posted

Nov 22, 2022Actual

Enrollment

338Actual

Phase

Not provided

Conditions

Covid19
Breastfeeding, Exclusive
Newborn Morbidity

Interventions

RT-PCR for SARS-Cov-2

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2021Actual

Primary Completion Date

Dec 12, 2021Actual

Completion Date

Dec 31, 2021Actual

First Submitted Date

Jun 8, 2021

First Submission Date that Met QC Criteria

Jun 8, 2021

First Posted Date

Jun 14, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2022

Last Update Posted Date

Nov 22, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Seda Yilmaz Semerci, Neonatologist, Kanuni Sultan Suleyman Training and Research HospitalPrincipal Investigator

Lead Sponsor

Kanuni Sultan Suleyman Training and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

338Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control Group		Infants of mothers with suspected but negative for COVID-19	Diagnostic Test: RT-PCR for SARS-Cov-2
Case Group		Infants Born to COVID-19 positive mothers	Diagnostic Test: RT-PCR for SARS-Cov-2

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RT-PCR for SARS-Cov-2	Diagnostic Test	Nasopharyngeal swab for detecting Novel Coronavirus-2 by reverse transcriptase polymerase chain reaction	Case Group Control Group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

7 Months

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kanuni Sultan Suleyman Training and Research Hospital		Istanbul	Kucukcekmece	34303	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D001942	Breast Feeding

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided