NCT03166826

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

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

First Submitted

Initial submission to the registry

May 11, 2016

Completed
12 months until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 25, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

August 13, 2019

Status Verified

August 1, 2019

Enrollment Period

10 months

First QC Date

May 11, 2016

Last Update Submit

August 12, 2019

Conditions

Neonatal Respiratory Failure

Outcome Measures

Primary Outcomes (1)

  • Modified Combined Apgar scoring

    The predictive value of Modified Combined Apgar scoring for hospitalization of infants

    10 months

Interventions

Modified Apgar Scoring SystemOTHER

Modified APGAR scoring system

Eligibility Criteria

AgeUp to 2 Hours
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Term and Preterm Neonates delivered in our hospital

You may qualify if:

  • Term neonates Preterm neonates Parental approval

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Kucukcekmece, 34303, Turkey (Türkiye)

Location

Study Officials

  • Seda Yilmaz Semerci, MD

    Kanuni Sultan Suleyman Training and Research Hospital

    STUDY DIRECTOR

  • Gokhan Buyukkale, MD

    Neonatologist

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, MD,PhD

Study Record Dates

First Submitted

May 11, 2016

First Posted

May 25, 2017

Study Start

May 1, 2017

Primary Completion

March 5, 2018

Study Completion

May 1, 2018

Last Updated

August 13, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)