NCT04337320

Brief Summary

Evaluation of apgar, hemogram and developmental status of babies born from covid 19 positive mothers

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 15, 2020

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 7, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2020

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

2 months

First QC Date

April 5, 2020

Last Update Submit

June 9, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluation of apgar status of newborns from covid 19 positive mothers

    The Apgar score is looked after at 1 and 5 minutes after birth, if the baby's Apgar score is lower than 7, it is repeated every 5 minutes until 20 minutes. Parameters examined in Apgar score Muscle tone, Heart rate, Reflexes, Skin color, Respiration. In the Apgar score, the baby is evaluated and scores are collected. 7 - 10: The baby is normal. 4 - 6: They usually recover with respiratory support. 0 - 3: Urgent intervention and resuscitation is needed. The low Apgar score in the 1st minute usually returns to normal in the 5th minute with support. Despite the intervention, the Apgar scores of 5 and less at 5 and 10 minutes are associated with an increased risk of mortality and cerebral palsy.

    2 months

Interventions

Evaluation of apgar, hemogram and developmental status of babies born from covid 19 positive mothers

Eligibility Criteria

Age1 Minute - 15 Minutes
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Evaluation of apgar, hemogram and developmental status of babies born from covid 19 positive mothers

You may qualify if:

  • from covid 19 positive mothers
  • newborn mothers had not other condition or illness

You may not qualify if:

  • from covid 19 negative mothers
  • childs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pinar Yalcin Bahat

Istanbul, İ̇stanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 5, 2020

First Posted

April 7, 2020

Study Start

March 15, 2020

Primary Completion

May 25, 2020

Study Completion

May 30, 2020

Last Updated

June 11, 2020

Record last verified: 2020-06

Locations