Development of Modified Combined Apgar Scoring System for Evaluation of Infants in the Delivery Room

August 12, 2019 updated by: Merih Cetinkaya, Kanuni Sultan Suleyman Training and Research Hospital
Apgar scoring system has been widely used for the evaluation of the infant's postnatal condition. As conventional Apgar scoring system is affected by gestational age and resuscitative efforts, there is a need for development of new scoring systems for the assessment in the delivery room. Herein, Modified Combined Apgar scoring system which includes two new parameters (cord blood pH and targeted oxygen saturation level) has been developed and the utility of this modified system was compared with Conventional and Combined Apgar scoring systems for prediction of hospitalization.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective cohort study. Conventional, Combined and Modified Combined Apgar scores at minutes 1 and 5 are all recorded. For Modified scoring system, blood sample is obtained from the umbilical artery and pulse oximetry is used for measurement of oxygen saturation. Prediction of NICU hospitalization is used as a surrogate parameter to compare the scores.

Study Type

Observational

Enrollment (Actual)

800

Contacts and Locations

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

Study Locations

  • Turkey
    • Kucukcekmece
      • Istanbul, Kucukcekmece, Turkey, 34303
        • Kanuni Sultan Suleyman Training and Research Hospital

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

No older than 2 hours (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Term and Preterm Neonates delivered in our hospital

Description

Inclusion Criteria:

Term neonates Preterm neonates Parental approval

Exclusion Criteria :

Major congenital/chromosomal abnormalities Lack of informed consent Stillbirth Outborn infants

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
Measure Description
Time Frame
Modified Combined Apgar scoring
Time Frame: 10 months
The predictive value of Modified Combined Apgar scoring for hospitalization of infants
10 months

Collaborators and Investigators

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

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Investigators

  • Study Director: Seda Yilmaz Semerci, MD, Kanuni Sultan Suleyman Training and Research Hospital
  • Study Director: Gokhan Buyukkale, MD, Neonatologist

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)

May 1, 2017

Primary Completion (Actual)

March 5, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

May 11, 2016

First Submitted That Met QC Criteria

May 24, 2017

First Posted (Actual)

May 25, 2017

Study Record Updates

Last Update Posted (Actual)

August 13, 2019

Last Update Submitted That Met QC Criteria

August 12, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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