This Study Investigate the Impact of Maternal COVID-19 Infection During Birth on the Childrens' Physical and Mental Development. (Coronababies)

June 20, 2022 updated by: Semmelweis University

Long-term Followup of Children Was Born From COVID Positive Mother During Birth

This study investigates the impact of the maternal COVID infection during birth on the children's development: physical and mental outcomes. We would like to differentiate the effect from the viral infection and effect of the pandemic period, too.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hungary
      • Budapest, Hungary, 1078
        • Recruiting
        • Semmelweis University, Department of Obstetrics and Gynecology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Firstly we examine the infants at 1 year old. We do control examination if it is necessary or give advice. We did a next examination at 2 years old in every cases.

Description

Inclusion Criteria:

  • postitive maternal COVID test during the birth
  • the newborn was cared at the Semmelweis University after birth

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Neurodevelopmental outcome
Time Frame: 2 years old
2 years old

Secondary Outcome Measures

Outcome Measure
Time Frame
Neurodevelopmental outcome
Time Frame: 1 year old
1 year old
Phsycosomatic outcome
Time Frame: 1 and 2 years old
1 and 2 years old
Regulation disorders
Time Frame: 1 and 2 years old
1 and 2 years old
Feeding
Time Frame: 1 and 2 years old
1 and 2 years old
Maternal mental status
Time Frame: 1 and 2 years old
1 and 2 years old

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Semmelweis University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2022

Primary Completion (Anticipated)

July 31, 2023

Study Completion (Anticipated)

June 30, 2024

Study Registration Dates

First Submitted

June 20, 2022

First Submitted That Met QC Criteria

June 20, 2022

First Posted (Actual)

June 24, 2022

Study Record Updates

Last Update Posted (Actual)

June 24, 2022

Last Update Submitted That Met QC Criteria

June 20, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SE RKEB: 14/2022.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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