Hearing LossNCT04014504
Pethidine Analgesia and Neonatal Hearing Screening Test
An observational study of Hearing Loss and Newborn Complication, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Neonatal hearing screening may fail due to some perinatal and neonatal factors. It is well known that false positivity in newborn hearing screening increases cost and maternal anxiety and anxiety. There is still widespread concern about the use of opoid analgesics to relieve pain during labor. Read more about this study
- Who is it for?
- Ages 24 hours to 14 days, women only
- Conditions the study is for
- Hearing Loss, Newborn Complication
- What is being tested?
- Neonatal Hearing Screening Test
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2017to 1 Jan 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 24 hours to 14 days
- Women only
- No healthy volunteers
- Child
Study population: term singleton pregnancy,Gave birth at 37-41 weeks of gestation, without chronic internal disease,Pregnant women were included in the study.
Who may be able to join
- term singleton pregnancy,
- Gave birth at 37-41 weeks of gestation,
- without chronic internal disease,
- Pregnant women were included in the study.
Who cannot join
- Newborn hospitalized in intensive care,
- congenital / chromosomal anomaly,
- congenital CMV infection,
- facial / ear deformities,
- family with hearing problems,
- those with hyperbilirunemia,
Show all 13Show fewer
- tested at <12 hours after birth,
- maternal infection,
- Diabetes mellitus, recurrent abortion,
- smoking,
- plesanta previa,
- prolonged premature rupture of the membrane (more than 12 hours), epidural -analgesia and
- newborns who were at risk of asphyxia hypoxia were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Süleyman Training and Research Hospital
Istanbul, 33404
About this study
Official title: Effect of Pethidine Analgesia on False Positivity in Neonatal Hearing Screening Test
Neonatal hearing screening may fail due to some perinatal and neonatal factors. It is well known that false positivity in newborn hearing screening increases cost and maternal anxiety and anxiety. There is still widespread concern about the use of opoid analgesics to relieve pain during labor. The aim of this study was to determine the effects of pethidine administered during labor on neonatal hearing screening test false positivity rates.
Read the detailed description
The study group consisted of patients receiving 50 mg intramuscular (I.M) pethidine at the beginning of the active phase of labor and the control group consisted of patients not receiving pethidine. Newborns were evaluated by otoacoustic emission (OAE) test. The OAE test was performed before the patients were discharged. Perinatal and neonatal variables and test results were recorded and the relationship between false positivity and pethidine use was evaluated.
- Conditions
- Hearing Loss, Newborn Complication
- Being tested
- Neonatal Hearing Screening Test
- Keywords
- Newborn Hearing Screening, Otoacoustic emissions, Pethidine, False positive
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neonatal Hearing Screening TestDiagnostic test
neonatal hearing screening test results will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| study group | The results of the hearing screening test of the beats of the patients who have undergone pethidine in the active phase of labor will be examined. the results will be reported as passed - remained; the false positivity rate according to the retest of the remaining group is to be looked at. Receives: Diagnostic Test: Neonatal Hearing Screening Test | |
| control group | In the active phase of labor, hearing screening test results of beats of pediatric patients will be evaluated. the results will be reported as passed - remained; the false positivity rate according to the retest of the remaining group is to be looked at. control group. Receives: Diagnostic Test: Neonatal Hearing Screening Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Hearing Screening Test
neonatal hearing screening test results will be evaluated. will be reported as left or passed.
The "pass'' en response observed in the hearing screening device indicates that the baby passed the screening test, and the" refer "response indicates that the baby has failed.
Measured: 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start1 Jan 2017
- Primary completion1 Jan 2018
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04014504
- Sponsor's protocol ID
- 2019.07.07
- Status last verified
- Jul 2019
- First submitted
- 7 Jul 2019
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pethidine Analgesia on False Positivity in Neonatal Hearing Screening Test
- ClinicalTrials.gov ID
- NCT04014504
- Acronym / sponsor ID
- 2019.07.07
- Conditions
- Hearing Loss, Newborn Complication
- Keywords
- Newborn Hearing Screening, Otoacoustic emissions, Pethidine, False positive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 10 Jul 2019 (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.
Neonatal hearing screening may fail due to some perinatal and neonatal factors. It is well known that false positivity in newborn hearing screening increases cost and maternal anxiety and anxiety. There is still widespread concern about the use of opoid analgesics to relieve pain during labor. The aim of this study was to determine the effects of pethidine administered during labor on neonatal hearing screening test false positivity rates.
Detailed description
The study group consisted of patients receiving 50 mg intramuscular (I.M) pethidine at the beginning of the active phase of labor and the control group consisted of patients not receiving pethidine. Newborns were evaluated by otoacoustic emission (OAE) test. The OAE test was performed before the patients were discharged. Perinatal and neonatal variables and test results were recorded and the relationship between false positivity and pethidine use was evaluated.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | Diagnostic Test: Neonatal Hearing Screening TestThe results of the hearing screening test of the beats of the patients who have undergone pethidine in the active phase of labor will be examined. the results will be reported as passed - remained; the false positivity rate according to the retest of the remaining group is to be looked at. |
| control group | – | Diagnostic Test: Neonatal Hearing Screening TestIn the active phase of labor, hearing screening test results of beats of pediatric patients will be evaluated. the results will be reported as passed - remained; the false positivity rate according to the retest of the remaining group is to be looked at. control group. |
Who may qualify
- Ages
- 24 hours to 14 days
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- term singleton pregnancy,Gave birth at 37-41 weeks of gestation, without chronic internal disease,Pregnant women were included in the study.
Key inclusion criteria (4 listed)
- term singleton pregnancy,
- Gave birth at 37-41 weeks of gestation,
- without chronic internal disease,
- Pregnant women were included in the study.
Key exclusion criteria (13 listed)
- Newborn hospitalized in intensive care,
- congenital / chromosomal anomaly,
- congenital CMV infection,
- facial / ear deformities,
- family with hearing problems,
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 |
|---|---|---|
| Neonatal Hearing Screening Testneonatal hearing screening test results will be evaluated. | Diagnostic test | control group, study group |
Primary outcome
Neonatal Hearing Screening Test
Time frame: 2 week
neonatal hearing screening test results will be evaluated. will be reported as left or passed. The "pass'' en response observed in the hearing screening device indicates that the baby passed the screening test, and the" refer "response indicates that the baby has failed.
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 12 Jul 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hearing Loss and Newborn Complication, 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 4 inclusion and 13 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 12 Jul 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?
Neonatal Hearing Screening Test (time frame: 2 week). 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 12 Jul 2019; AzTrials last refreshed its copy on 1 Nov 2026.