Neonatal Respiratory FailureNCT03166826
Development of Modified Combined Apgar Scoring System for Evaluation of Infants in the Delivery Room
An observational study of Neonatal Respiratory Failure, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages Up to 2 hoursHealthy volunteers can take part
- Conditions the study is for
- Neonatal Respiratory Failure
- What is being tested?
- Modified Apgar Scoring System
- How many people
- 800 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2017to 1 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 hours
- All sexes
- Healthy volunteers accepted
- Child
Study population: Term and Preterm Neonates delivered in our hospital
Who may be able to join
- Term neonates Preterm neonates Parental approval
Who cannot join
- Major congenital/chromosomal abnormalities Lack of informed consent Stillbirth Outborn infants
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, Kucukcekmece, 34303
About this study
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.
Read the 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.
- Conditions
- Neonatal Respiratory Failure
- Being tested
- Modified Apgar Scoring System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Apgar Scoring SystemOther
Modified APGAR scoring system
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Combined Apgar scoring
The predictive value of Modified Combined Apgar scoring for hospitalization of infants
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study start1 May 2017
- Primary completion5 Mar 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merih Cetinkaya, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Seda Yilmaz Semerci, MD, Study director, Kanuni Sultan Suleyman Training and Research HospitalGokhan Buyukkale, MD, Study director, Neonatologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03166826
- Sponsor's protocol ID
- 4
- Status last verified
- Aug 2019
- First submitted
- 11 May 2016
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Modified Combined Apgar Scoring System for Evaluation of Infants in the Delivery Room
- ClinicalTrials.gov ID
- NCT03166826
- Acronym / sponsor ID
- 4
- Conditions
- Neonatal Respiratory Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 5 Mar 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 25 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 2 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Term and Preterm Neonates delivered in our hospital
Key inclusion criteria (1 listed)
- Term neonates Preterm neonates Parental approval
Key exclusion criteria (1 listed)
- Major congenital/chromosomal abnormalities Lack of informed consent Stillbirth Outborn infants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Apgar Scoring SystemModified APGAR scoring system | Other | – |
Primary outcome
Modified Combined Apgar scoring
Time frame: 10 months
The predictive value of Modified Combined Apgar scoring for hospitalization of infants
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seda Yilmaz Semerci, MD study director
Kanuni Sultan Suleyman Training and Research Hospital
Gokhan Buyukkale, MD study director
Neonatologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Respiratory Failure, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Combined Apgar scoring (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2019.