Impact of Maternal COVID-19 Disease on Breast Milk and In... | NCT04768244

Studies
Impact of Maternal COVID-19 Disease on Breast Milk and Infant Health

NCT04768244

Sponsor

Institute of Agrochemistry and Food Technology, National Research Council

Status

Completed

Last Update Posted

Oct 25, 2023Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Covid19

Interventions

maternal SARS-CoV-2 infection

Countries

Spain

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

Oct 2023

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

Apr 1, 2020Actual

Primary Completion Date

Mar 31, 2023Actual

Completion Date

Oct 10, 2023Actual

First Submitted Date

Feb 10, 2021

First Submission Date that Met QC Criteria

Feb 22, 2021

First Posted Date

Feb 24, 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

Oct 24, 2023

Last Update Posted Date

Oct 25, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Maria Carmen Collado, PhD, Research Scientist, Institute of Agrochemistry and Food Technology, National Research CouncilPrincipal Investigator

Lead Sponsor

Institute of Agrochemistry and Food Technology, National Research CouncilOTHER_GOV

Collaborators

Name	Class
Hospital Universitario La Fe	OTHER
Instituto de Investigacion Sanitaria INCLIVA	OTHER
Hospital Clínico Universitario de Valencia	OTHER
Hospital Universitario Doctor Peset

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

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

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

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
COVID19		- Women with SARS-CoV-2 infections	Other: maternal SARS-CoV-2 infection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
maternal SARS-CoV-2 infection	Other	positive PCR in nasopharinx and/or presence of antibodies in serum	COVID19

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SARS-CoV-2 RNA	levels of viral RNA from SARS-CoV-2 in breast milk	1 month

Secondary Outcomes

Measure	Description	Time Frame
breast milk immune	interleukines, cytokines and growth factors, immunoglobulins	1st year
breast milk microbiota	microbiota composition and diversity

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Pregnant women at the end of the pregnancy and also, lactating women

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Women with SARS-CoV-2 infection at the end of pregnancy, before delivery following hospitals COVID19 screening protocols.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fundacion Investigacion Sanitaria INCLIVA		Valencia			Spain
Hospital Universitario y Politecnico la Fe

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34417223	Derived	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.

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