Clinical Trials Logo
  1. Home
  2. Covid19
  3. NCT04925908
  4. Details
NCT04925908 Clinical Trial

Exclusive Breastfeeding in Infants of Mothers Infected With Novel Coronavirus

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04925908
Other study ID # KAEK/2021.05.165
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2021
Est. completion date December 31, 2021

Study information
Verified date November 2022
Source Kanuni Sultan Suleyman Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 338
Est. completion date December 31, 2021
Est. primary completion date December 12, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 7 Months
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• RT-PCR for SARS-Cov-2
Nasopharyngeal swab for detecting Novel Coronavirus-2 by reverse transcriptase polymerase chain reaction

Locations
Country Name City State
Turkey Kanuni Sultan Suleyman Training and Research Hospital Istanbul Kucukcekmece

Sponsors (1)
Lead Sponsor Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Exclusive breastfeeding Rate of exclusive breastfeeding 6 months
Secondary Disease status COVID-19 positive/negative 6 months
See also
  Status Clinical Trial Phase
Completed NCT05047692 - Safety and Immunogenicity Study of AdCLD-CoV19-1: A COVID-19 Preventive Vaccine in Healthy Volunteers Phase 1
Recruiting NCT04395768 - International ALLIANCE Study of Therapies to Prevent Progression of COVID-19 Phase 2
Completed NCT04506268 - COVID-19 SAFE Enrollment N/A
Completed NCT04508777 - COVID SAFE: COVID-19 Screening Assessment for Exposure
Terminated NCT04555096 - A Trial of GC4419 in Patients With Critical Illness Due to COVID-19 Phase 2
Completed NCT04961541 - Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine Phase 1/Phase 2
Active, not recruiting NCT04546737 - Study of Morphological, Spectral and Metabolic Manifestations of Neurological Complications in Covid-19 Patients N/A
Completed NCT04532294 - Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants Phase 1
Not yet recruiting NCT04543006 - Persistence of Neutralizing Antibodies 6 and 12 Months After a Covid-19 N/A
Terminated NCT04542993 - Can SARS-CoV-2 Viral Load and COVID-19 Disease Severity be Reduced by Resveratrol-assisted Zinc Therapy Phase 2
Terminated NCT04581915 - PHRU CoV01 A Trial of Triazavirin (TZV) for the Treatment of Mild-moderate COVID-19 Phase 2/Phase 3
Completed NCT04494646 - BARCONA: A Study of Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19) Phase 2
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT04387292 - Ocular Sequelae of Patients Hospitalized for Respiratory Failure During the COVID-19 Epidemic N/A
Completed NCT04537663 - Prevention Of Respiratory Tract Infection And Covid-19 Through BCG Vaccination In Vulnerable Older Adults Phase 4
Not yet recruiting NCT04527211 - Effectiveness and Safety of Ivermectin for the Prevention of Covid-19 Infection in Colombian Health Personnel Phase 3
Completed NCT04979858 - Reducing Spread of COVID-19 in a University Community Setting: Role of a Low-Cost Reusable Form-Fitting Fabric Mask N/A
Not yet recruiting NCT05038449 - Study to Evaluate the Efficacy and Safety of Colchicine Tablets in Patients With COVID-19 N/A
Completed NCT04610502 - Efficacy and Safety of Two Hyperimmune Equine Anti Sars-CoV-2 Serum in COVID-19 Patients Phase 2
Active, not recruiting NCT06042855 - ACTIV-6: COVID-19 Study of Repurposed Medications - Arm G (Metformin) Phase 3