NCT04519307

Brief Summary

This study evaluates the newborns who had respiratory symptoms at the neonatal intensive care admission

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2020

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

August 19, 2020

Status Verified

August 1, 2020

Enrollment Period

5 months

First QC Date

August 18, 2020

Last Update Submit

August 18, 2020

Conditions

Viral Infection

Keywords

newborncovid infectionviral infection

Outcome Measures

Primary Outcomes (1)

  • General Characteristics of the infants with respiratory infection at the NICU admission

    Demographical characteristics will be recorded

    5 months

Study Arms (2)

Group 1

The newborns with covid 19 infection

Group 2

The newborns with no covid 19 infection

Eligibility Criteria

AgeUp to 1 Month
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

All newborns who had respiratory symptoms at the NICU admission

You may qualify if:

  • All newborns who had respiratory symptoms at the NICU admission

You may not qualify if:

  • Congenital abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İzmir Dr. Behcet Uz Training and Research Hospital

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Virus Diseases

Condition Hierarchy (Ancestors)

Infections

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Neonatology

Study Record Dates

First Submitted

August 18, 2020

First Posted

August 19, 2020

Study Start

March 1, 2020

Primary Completion

August 1, 2020

Study Completion

August 31, 2020

Last Updated

August 19, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will share

Locations

TU(1)