Covid19MilkCoronaNCT04768244
Impact of Maternal COVID-19 Disease on Breast Milk and Infant Health
An observational study of Covid19, run by Institute of Agrochemistry and Food Technology, National Research Council at 2 sites in Spain.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- maternal SARS-CoV-2 infection
- How many people
- 100 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Apr 2020to 10 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women with SARS-CoV-2 infection at the end of pregnancy, before delivery following hospitals COVID19 screening protocols.
Who may be able to join
- 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
Who cannot join
- aggravation of symptomatology requiring specific treatment and/or hospitalization
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Fundacion Investigacion Sanitaria INCLIVA
Valencia
Hospital Universitario y Politecnico la Fe
Valencia
About this study
Official title: Impact of Maternal SARS-CoV-2 Infection and Vaccination on Breast Milk Antibodies, Milk Bioactive Compounds and Maternal-child Health (MilkCORONA)
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
- Conditions
- Covid19
- Being tested
- maternal SARS-CoV-2 infection
- Keywords
- Breast milk, Microbiota, Sars-CoV-2, metabolites, immune compounds, infant growth and development
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maternal SARS-CoV-2 infectionOther
positive PCR in nasopharinx and/or presence of antibodies in serum
| Study group | Role | What they receive |
|---|---|---|
| COVID19 | - Women with SARS-CoV-2 infections Receives: Other: maternal SARS-CoV-2 infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV-2 RNA
levels of viral RNA from SARS-CoV-2 in breast milk
Measured: 1 month
Secondary outcomes (5)
breast milk immune
interleukines, cytokines and growth factors, immunoglobulins
Measured: 1st year
breast milk microbiota
microbiota composition and diversity
Measured: 1st year
breast milk metabolite
metabolite profile
Measured: 1st year
infant microbiota
infant microbiota profile
Measured: 1st year
infant growth and development
z-scores growth curves
Measured: 1st year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start1 Apr 2020
- Primary completion31 Mar 2023
- Study completion10 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Agrochemistry and Food Technology, National Research Council
- Sponsor type
- Other government
- Collaborators
- Hospital Universitario La Fe, Instituto de Investigacion Sanitaria 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
- Responsible party
- Principal investigator, Maria Carmen Collado, Institute of Agrochemistry and Food Technology, National Research Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04768244
- Sponsor's protocol ID
- covid1
- Acronym
- MilkCorona
- Status last verified
- Oct 2023
- First submitted
- 10 Feb 2021
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34417223
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Maternal SARS-CoV-2 Infection and Vaccination on Breast Milk Antibodies, Milk Bioactive Compounds and Maternal-child Health (MilkCORONA)
- ClinicalTrials.gov ID
- NCT04768244
- Acronym / sponsor ID
- MilkCorona / covid1
- Conditions
- Covid19
- Keywords
- Breast milk, Microbiota, Sars-CoV-2, metabolites, immune compounds, infant growth and development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Institute of Agrochemistry and Food Technology, National Research CouncilOther government
- Collaborators
- Hospital Universitario La Fe, Instituto de Investigacion Sanitaria 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
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 24 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID19 | – | Other: maternal SARS-CoV-2 infection- Women with SARS-CoV-2 infections |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women with SARS-CoV-2 infection at the end of pregnancy, before delivery following hospitals COVID19 screening protocols.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- aggravation of symptomatology requiring specific treatment and/or hospitalization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| maternal SARS-CoV-2 infectionpositive PCR in nasopharinx and/or presence of antibodies in serum | Other | COVID19 |
Primary outcome
SARS-CoV-2 RNA
Time frame: 1 month
levels of viral RNA from SARS-CoV-2 in breast milk
5 secondary outcomes
breast milk immune
Time frame: 1st year
breast milk microbiota
Time frame: 1st year
breast milk metabolite
Time frame: 1st year
infant microbiota
Time frame: 1st year
infant growth and development
Time frame: 1st year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Derived from this study: PubMed 34417223Bauerl 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Institute of Agrochemistry and Food Technology, National Research Council at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SARS-CoV-2 RNA (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04768244, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2023.