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Impact of Maternal COVID-19 Disease on Breast Milk and Infant Health (MilkCorona)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04768244
Recruitment Status : Recruiting
First Posted : February 24, 2021
Last Update Posted : March 29, 2022
Sponsor:
Collaborators:
Hospital Universitario La Fe
INCLIVA
Hospital Clínico Universitario de Valencia
Hospital Universitario Doctor Peset
Universidad de Granada
Universitat Jaume I
Hospital Sant Joan de Deu
Fetal Medicine Research Center, Spain
Instituto de Investigación Sanitaria Aragón
Information provided by (Responsible Party):
Maria Carmen Collado, Institute of Agrochemistry and Food Technology, National Research Council

Tracking Information
First Submitted Date February 10, 2021
First Posted Date February 24, 2021
Last Update Posted Date March 29, 2022
Actual Study Start Date April 1, 2020
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 22, 2021)		 SARS-CoV-2 RNA [ Time Frame: 1 month ]
levels of viral RNA from SARS-CoV-2 in breast milk
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 23, 2021)
  • breast milk immune [ Time Frame: 1st year ]
    interleukines, cytokines and growth factors, immunoglobulins
  • breast milk microbiota [ Time Frame: 1st year ]
    microbiota composition and diversity
  • breast milk metabolite [ Time Frame: 1st year ]
    metabolite profile
  • infant microbiota [ Time Frame: 1st year ]
    infant microbiota profile
  • infant growth and development [ Time Frame: 1st year ]
    z-scores growth curves
Original Secondary Outcome Measures
 (submitted: February 22, 2021)
  • breast milk immune [ Time Frame: 1st year ]
    levels of interleukines, cytokines and growth factors, immunoglobulins
  • breast milk microbiota [ Time Frame: 1st year ]
    microbiota composition and
  • breast milk metabolite [ Time Frame: 1st year ]
    metabolite profile
  • infant microbiota [ Time Frame: 1st year ]
    infant microbiota profile
  • infant growth and development [ Time Frame: 1st year ]
    z-scores growth curves
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Impact of Maternal COVID-19 Disease on Breast Milk and Infant Health
Official Title Impact of Maternal SARS-CoV-2 Infection and Vaccination on Breast Milk Antibodies, Milk Bioactive Compounds and Maternal-child Health (MilkCORONA)
Brief Summary prospective multicenter study The main aim is to study the impact of maternal COVID-19 on breast milk immune, microbiological, and metabolic profile and infant growth and development
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Women with SARS-CoV-2 infection at the end of pregnancy, before delivery following hospitals COVID19 screening protocols.
Condition Covid19
Intervention Other: maternal SARS-CoV-2 infection
positive PCR in nasopharinx and/or presence of antibodies in serum
Study Groups/Cohorts COVID19
- Women with SARS-CoV-2 infections
Intervention: Other: maternal SARS-CoV-2 infection
Publications * Bauerl C, Randazzo W, Sanchez G, Selma-Royo M, Garcia Verdevio E, Martinez L, Parra-Llorca A, Lerin C, Fumado V, Crovetto F, Crispi F, Perez-Cano FJ, Rodriguez G, Ruiz-Redondo G, Campoy C, Martinez-Costa C, Collado MC; MilkCORONA study team. SARS-CoV-2 RNA and antibody detection in breast milk from a prospective multicentre study in Spain. Arch Dis Child Fetal Neonatal Ed. 2022 Mar;107(2):216-221. doi: 10.1136/archdischild-2021-322463. Epub 2021 Aug 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 22, 2021)		 100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • pregnant or nursing women with positive PCR for SARS-CoV-2 in nasopharynge and/or presence of SARS-CoV-2 antibodies in serum determined in hospitals

Exclusion Criteria:

  • aggravation of symptomatology requiring specific treatment and/or hospitalization
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Pregnant women at the end of the pregnancy and also, lactating women
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT04768244
Other Study ID Numbers covid1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Maria Carmen Collado, Institute of Agrochemistry and Food Technology, National Research Council
Original Responsible Party Same as current
Current Study Sponsor Institute of Agrochemistry and Food Technology, National Research Council
Original Study Sponsor Same as current
Collaborators
  • Hospital Universitario La Fe
  • INCLIVA
  • Hospital Clínico Universitario de Valencia
  • Hospital Universitario Doctor Peset
  • Universidad de Granada
  • Universitat Jaume I
  • Hospital Sant Joan de Deu
  • Fetal Medicine Research Center, Spain
  • Instituto de Investigación Sanitaria Aragón
Investigators Not Provided
PRS Account Institute of Agrochemistry and Food Technology, National Research Council
Verification Date March 2022