Exclusive Breastfeeding in Infants of Mothers Infected With Novel Coronavirus

Completed

• Conditions: Covid19; Breastfeeding, Exclusive; Newborn Morbidity
• Interventions: Diagnostic Test: RT-PCR for SARS-Cov-2

• Registration Number: NCT04925908
• Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

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.

Study Timeline

• Study Start: 2021-06-01
• Study First Submitted: 2021-06-08
• Study First Submitted QC: 2021-06-08
• Study First Posted: 2021-06-14
• Primary Completion: 2021-12-12
• Study Completion: 2021-12-31
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-18
• Last Update Posted: 2022-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 338

Inclusion Criteria

• Infants who were born to mothers with suspected or evident COVID-19
• Accepted to participate with an informed consent of parents

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Exclusion Criteria

• Congenital abnormalities
• Chromosomal abnormalities
• Contraindication for breastfeeding
• Declined to participate

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Exclusive breastfeeding	6 months	Rate of exclusive breastfeeding

Secondary Outcome Measures

Name	Time	Method
Disease status	6 months	COVID-19 positive/negative

Trial Locations

Locations (1)

Kanuni Sultan Suleyman Training and Research Hospital; 🇹🇷 Istanbul, Kucukcekmece, Turkey