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NCT03166826 Clinical Trial

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

Neonatal Respiratory Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03166826
Other study ID # 4
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2017
Est. completion date May 1, 2018

Study information
Verified date August 2019
Source Kanuni Sultan Suleyman Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 800
Est. completion date May 1, 2018
Est. primary completion date March 5, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 2 Hours
Eligibility Inclusion Criteria:

Term neonates Preterm neonates Parental approval

Exclusion Criteria :

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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Modified Apgar Scoring System
Modified APGAR scoring system

Locations
Country Name City State
Turkey Kanuni Sultan Suleyman Training and Research Hospital Istanbul Kucukcekmece

Sponsors (1)
Lead Sponsor Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Modified Combined Apgar scoring The predictive value of Modified Combined Apgar scoring for hospitalization of infants 10 months
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