Vital SignsNCT05868980
The Effect of Postnatal Lying Position on Cerebral Oxygenation in Newborns
An observational study of Vital Signs, run by Dr. Behcet Uz Children's Hospital at 1 site in Turkey (Türkiye).
Trial summary
In the international delivery room guidelines, it is not specified which position is optimal for the baby stabilization. Here, the investigators want to evaluate the effects of the positions on postnatal adaptation and cerebral oxygenation in the delivery room of infants who did not require resuscitation. Read more about this study
- Who is it for?
- Ages 2 to 10 minutesHealthy volunteers can take part
- Conditions the study is for
- Vital Signs
- What is being tested?
- vital signs by postpartum position
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2019to 1 Jun 2019
- 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 2 to 10 minutes
- All sexes
- Healthy volunteers accepted
- Child
Study population: newborn
Who may be able to join
- born with cesarean sectio (CS) could not exposed to early skin-to-skin contact
Who cannot join
- Vaginal birth
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Faculty of Medicine, Department of Child Health and Disease, Neonatal Department
Izmır
About this study
In the international delivery room guidelines, it is not specified which position is optimal for the baby stabilization. Here, the investigators want to evaluate the effects of the positions on postnatal adaptation and cerebral oxygenation in the delivery room of infants who did not require resuscitation.
Infants will be randomly stabilized in the supine, right-side, left-side and prone positions (60 babies in all, 15/position). The investigators will record the 1st and 5th min Apgar scores and the heart rate, pulse oximetry and perfusion index at 2nd,5th and 10thmin. Near-infrared spectroscopy will be used to assess cerebral regional oxygen saturation.
Read the detailed description
This was a prospective, randomized, observational study performed in 2 months by the Newborn Department in the Delivery Room of the Department of Obstetrics and Gynecology where approximately 3,500 infants are delivered annually. Stabilization followed the NRP guideline and is implemented by a neonatology fellow and three pediatric assistants with NRP certificates. Single, term, appropriate for gestational age (AGA) babies who did not need resuscitation and babies in whom skin-to-skin contact cannot be applied were included in the study. Vaginal births were not included, only babies born with cesarean sectio (CS) and could not not exposed to early skin-to-skin contact were included.
Spinal anesthesia was used for the mothers for CS, mother was not given oxygen therapy until the baby came out. Parents were informed of the study prior to birth and written consent was obtained from those who were willing to participate. The babies were randomized by opening of envelopes containing positional codes and were placed supine, on the right or left side, or prone (15/group).
- Infant positioning: Infants were placed under radiant heat for 10 min in the various positions; first-step resuscitation was performed in a routine manner. Infants with a need for positive pressure ventilation were excluded; all were placed supine.
- Medical records and vital parameters: All evaluations commenced 30 s after delivery and terminated at 10 min. For each infant, the 1st and 5th min Apgar scores were calculated by the same person, and the heart rate (HR), pulse oximetry, and perfusion index (PI) were recorded at 2nd, 5th, and 10th min using a Masimo Radical-7 pulse co-oximetry with an adhesive sensor. The probe was placed preductally (on the right wrist) and then connected to the oximetry. The fraction of inspired oxygen (FiO2) was only 0.21 ("room-air") during all the stabilization period. In line with the NRP 2015 guideline, aspiration was not routinely performed in the delivery room; the number of times that touch stimulation was required and the tactile stimulus time were recorded. Although electrocardiography (ECG) recommended in the latest guidelines and reads heart rate much faster, pulse oximetry had to be used in our study because the relationship between position and saturation and cerebral oximetry was evaluated.
- Cerebral oxygenation: Near-infrared spectroscopy (NIRS), which measures tissue oxygenation noninvasively, was used to evaluate cerebral oxygenation; the mean values at 5th and 10th min were recorded using a Covidien INVOS 5100C instrument. The cerebral regional cerebral oxygen saturation (rScO2) is the ratio of cerebral oxygenated hemoglobin (CHbO2) to the total oxygen bound to cerebral hemoglobin (CHb) and CHbO2 (rScO2 = CHbO2/CHb + CHbO2) (1). The rScO2 is the mean oxygen saturation of cerebral arterial, venule, and capillary blood; the venule data is predominate (2). Infrared light reveals the extent of saturation of the so-called watershed zone (a mixture of 33% arterial and 67% venous blood at a depth of 1-1,5 cm) (3). The NIRS probe was placed on both sides of the frontal lobe; the probe was cleaned before placement. The first measured value served as the basal value; rScO2 changes were then recorded at 2-s intervals to 60 s and the mean calculated. The cerebral rScO2 is normally 50-80, but may vary by 10-20% at any time (4). A decrease >20% for patients with a basal cerebral rScO2 value >50 and a decrease >15% for those with a basal cerebral rScO2 <50 indicate cerebral ischemia (5). Data were captured at 0.1 Hz and collected for 10 min, after application in each position consequently. Cerebral fractional oxygen extraction (cFOE) was calculated for 5th and 10th min average as ( (SpO2-rScO2)/SpO2 ) (SpO2: pulse oximetry oxygen saturation) for each position, which reflects the balance between oxygen delivery and consumption in the tissue (6). An infant/pediatric sensor (Covidien INVOS 5100C) costs between $110 and $140 each. No outside funding was used for the budget in this study. Within the budget and time period, the maximum number of patients enrolled in the study.
- Sample Size: In the investigators' center, monthly birth rate is 300 and since our hospital is the largest perinatology center in our region; the number of births with maternal and neonatal problems is high. When the investigators evaluated our records for the number of infants who were born > 37 GA with CS under spinal anesthesia and did not require any resuscitation efforts; the number was approximately 15 per month. (P=0.05) with a 2-sided a error of 5% and power of 80%, a total sample size of 37 total was required.
- Statistical Analyses:
SPSS 25.0 (IBM Corporation, Armonk, New York, United States) and PAST 3 (Hammer, Ø., Harper, D.A.T., Ryan, P.D. 2001. Paleontological statistics) programs were used in the analysis of the variables. The conformity of univariate data to normal distribution was evaluated with the Shapiro-Wilk francia test, while homogeneity of variance was evaluated with the Levene test. Mardia for the conformity of multivariate data to normal distribution; while the (Dornik and Hansen omnibus) test was used, the Box-M test was used for variance homogeneity. In the comparison of more than two groups according to quantitative data, Fisher's Least Significant Difference (LSD) tests were used for One-Way Anova post hoc analysis, one of the parametric methods, Kruskal-Wallis H Test, which is one of the nonparametric tests, was used with the results of Monte Carlo simulation technique, and Dunn's Test was used for Post Hoc analyses. The Paired-Samples T test was tested using Bootstrap results, while the Wilcoxon Signed Ranks Test was tested using the monte carlo simulation method to compare two replicate measurements of dependent quantitative variables with each other. While Friedman's Two-Way test was tested using the monte carlo simulation method to test the variables with more than two repeated measurements and to examine the interaction according to the groups, the General Linear Model-Repeated Anova test from parametric methods was used, and the LSD test was used for Post Hoc analyses. In the comparison of categorical variables with each other, Fisher-Freeman-Holton test was tested with Monte Carlo Simulation technique. While quantitative variables were expressed as mean (standard deviation) and Median (Percentile 25 / Percentile 75) in the tables, categorical variables were shown as n (%). The variables were analyzed at 95% confidence level, and a p value less than 0.05 was considered significant.
- Conditions
- Vital Signs
- Being tested
- vital signs by postpartum position
- Keywords
- delivery room, neonatal resuscitation, postnatal adaptation, cerebral oxygenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vital signs by postpartum positionOther
Evaluation of vital signs and NIRS values in 4 different positions after birth
| Study group | Role | What they receive |
|---|---|---|
| supine | supine position: Evaluation position for the first 10 minutes after birth Receives: Other: vital signs by postpartum position | |
| right-side | right-side position: Evaluation position for the first 10 minutes after birth Receives: Other: vital signs by postpartum position | |
| left-side | left-side position: Evaluation position for the first 10 minutes after birth Receives: Other: vital signs by postpartum position | |
| prone | prone position: Evaluation position for the first 10 minutes after birth Receives: Other: vital signs by postpartum position |
What is being measured
The primary outcome is the main question the study is designed to answer.
near infrared spectroscopy (NIRS) for each position at delivery room
near infrared spectroscopy
Measured: 10 minutes
fractional oxygean extraction (FOE) for each position at delivery room
fractional oxygean extraction
Measured: 10 minutes
postnatal adaptation on vital parameters as heart rate for each position at delivery room
heart rate
Measured: 10 minutes
postnatal adaptation on vital parameters as pulseoximeter for each position at delivery room
pulseoximeter
Measured: 10 minutes
postnatal adaptation on vital parameters as perfusion index for each position at delivery room
perfusion index
Measured: 10 minutes
Apgar scores for each position at delivery roomat delivery room
apgar scores
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start1 Feb 2019
- Primary completion1 Apr 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Vital SignsStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Behcet Uz Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ezgi yangin ergon, Dr. Behcet Uz Children's Hospital
- Investigators
- ruya colak, Study chair, Dr Behçet Uz Children's Diseases and Surgery Training and Research Hospital, Neonatal Departmentdemet terek, Study chair, Ege University Faculty of Medicine, Department of Child Health and Disease, Neonatal Departmentozge altun koroglu, Study chair, Ege University Faculty of Medicine, Department of Child Health and Disease, Neonatal Departmentsebnem calkavur, Study chair, Dr Behçet Uz Children's Diseases and Surgery Training and Research Hospital, Neonatal Departmentmehmet yalaz, Study chair, Ege University Faculty of Medicine, Department of Child Health and Disease, Neonatal Departmentnilgun kultursay, Study chair, Ege University Faculty of Medicine, Department of Child Health and Disease, Neonatal Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868980
- Sponsor's protocol ID
- 2018/193
- Status last verified
- May 2023
- First submitted
- 31 Mar 2023
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mutoh T, Guest RJ, Lamm WJ, Albert RK. Prone position alters the effect of volume overload on regional pleural pressures and improves hypoxemia in pigs in vivo. Am Rev Respir Dis. 1992 Aug;146(2):300-6. doi: 10.1164/ajrccm/146.2.300.
PubMed 1489116Hou X, Ding H, Teng Y, Zhou C, Tang X, Li S, Ding H. Research on the relationship between brain anoxia at different regional oxygen saturations and brain damage using near-infrared spectroscopy. Physiol Meas. 2007 Oct;28(10):1251-65. doi: 10.1088/0967-3334/28/10/010. Epub 2007 Sep 28.
PubMed 17906392Brodsky JB. What intraoperative monitoring makes sense? Chest. 1999 May;115(5 Suppl):101S-105S. doi: 10.1378/chest.115.suppl_2.101s.
PubMed 10331341Baikoussis NG, Karanikolas M, Siminelakis S, Matsagas M, Papadopoulos G. Baseline cerebral oximetry values in cardiac and vascular surgery patients: a prospective observational study. J Cardiothorac Surg. 2010 May 24;5:41. doi: 10.1186/1749-8090-5-41.
PubMed 20497559Samra SK, Dy EA, Welch K, Dorje P, Zelenock GB, Stanley JC. Evaluation of a cerebral oximeter as a monitor of cerebral ischemia during carotid endarterectomy. Anesthesiology. 2000 Oct;93(4):964-70. doi: 10.1097/00000542-200010000-00015.
PubMed 11020747Naulaers G, Meyns B, Miserez M, Leunens V, Van Huffel S, Casaer P, Weindling M, Devlieger H. Use of tissue oxygenation index and fractional tissue oxygen extraction as non-invasive parameters for cerebral oxygenation. A validation study in piglets. Neonatology. 2007;92(2):120-6. doi: 10.1159/000101063. Epub 2007 Mar 23.
PubMed 17377413
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Postnatal Lying Position on Cerebral Oxygenation in Newborns
- ClinicalTrials.gov ID
- NCT05868980
- Acronym / sponsor ID
- 2018/193
- Conditions
- Vital Signs
- Keywords
- delivery room, neonatal resuscitation, postnatal adaptation, cerebral oxygenation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dr. Behcet Uz Children's HospitalUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 22 May 2023 (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.
In the international delivery room guidelines, it is not specified which position is optimal for the baby stabilization. Here, the investigators want to evaluate the effects of the positions on postnatal adaptation and cerebral oxygenation in the delivery room of infants who did not require resuscitation.
Infants will be randomly stabilized in the supine, right-side, left-side and prone positions (60 babies in all, 15/position). The investigators will record the 1st and 5th min Apgar scores and the heart rate, pulse oximetry and perfusion index at 2nd,5th and 10thmin. Near-infrared spectroscopy will be used to assess cerebral regional oxygen saturation.
Detailed description
This was a prospective, randomized, observational study performed in 2 months by the Newborn Department in the Delivery Room of the Department of Obstetrics and Gynecology where approximately 3,500 infants are delivered annually. Stabilization followed the NRP guideline and is implemented by a neonatology fellow and three pediatric assistants with NRP certificates. Single, term, appropriate for gestational age (AGA) babies who did not need resuscitation and babies in whom skin-to-skin contact cannot be applied were included in the study. Vaginal births were not included, only babies born with cesarean sectio (CS) and could not not exposed to early skin-to-skin contact were included.
Spinal anesthesia was used for the mothers for CS, mother was not given oxygen therapy until the baby came out. Parents were informed of the study prior to birth and written consent was obtained from those who were willing to participate. The babies were randomized by opening of envelopes containing positional codes and were placed supine, on the right or left side, or prone (15/group).
- Infant positioning: Infants were placed under radiant heat for 10 min in the various positions; first-step resuscitation was performed in a routine manner. Infants with a need for positive pressure ventilation were excluded; all were placed supine.
- Medical records and vital parameters: All evaluations commenced 30 s after delivery and terminated at 10 min. For each infant, the 1st and 5th min Apgar scores were calculated by the same person, and the heart rate (HR), pulse oximetry, and perfusion index (PI) were recorded at 2nd, 5th, and 10th min using a Masimo Radical-7 pulse co-oximetry with an adhesive sensor. The probe was placed preductally (on the right wrist) and then connected to the oximetry. The fraction of inspired oxygen (FiO2) was only 0.21 ("room-air") during all the stabilization period. In line with the NRP 2015 guideline, aspiration was not routinely performed in the delivery room; the number of times that touch stimulation was required and the tactile stimulus time were recorded. Although electrocardiography (ECG) recommended in the latest guidelines and reads heart rate much faster, pulse oximetry had to be used in our study because the relationship between position and saturation and cerebral oximetry was evaluated.
- Cerebral oxygenation: Near-infrared spectroscopy (NIRS), which measures tissue oxygenation noninvasively, was used to evaluate cerebral oxygenation; the mean values at 5th and 10th min were recorded using a Covidien INVOS 5100C instrument. The cerebral regional cerebral oxygen saturation (rScO2) is the ratio of cerebral oxygenated hemoglobin (CHbO2) to the total oxygen bound to cerebral hemoglobin (CHb) and CHbO2 (rScO2 = CHbO2/CHb + CHbO2) (1). The rScO2 is the mean oxygen saturation of cerebral arterial, venule, and capillary blood; the venule data is predominate (2). Infrared light reveals the extent of saturation of the so-called watershed zone (a mixture of 33% arterial and 67% venous blood at a depth of 1-1,5 cm) (3). The NIRS probe was placed on both sides of the frontal lobe; the probe was cleaned before placement. The first measured value served as the basal value; rScO2 changes were then recorded at 2-s intervals to 60 s and the mean calculated. The cerebral rScO2 is normally 50-80, but may vary by 10-20% at any time (4). A decrease >20% for patients with a basal cerebral rScO2 value >50 and a decrease >15% for those with a basal cerebral rScO2 <50 indicate cerebral ischemia (5). Data were captured at 0.1 Hz and collected for 10 min, after application in each position consequently. Cerebral fractional oxygen extraction (cFOE) was calculated for 5th and 10th min average as ( (SpO2-rScO2)/SpO2 ) (SpO2: pulse oximetry oxygen saturation) for each position, which reflects the balance between oxygen delivery and consumption in the tissue (6). An infant/pediatric sensor (Covidien INVOS 5100C) costs between $110 and $140 each. No outside funding was used for the budget in this study. Within the budget and time period, the maximum number of patients enrolled in the study.
- Sample Size: In the investigators' center, monthly birth rate is 300 and since our hospital is the largest perinatology center in our region; the number of births with maternal and neonatal problems is high. When the investigators evaluated our records for the number of infants who were born > 37 GA with CS under spinal anesthesia and did not require any resuscitation efforts; the number was approximately 15 per month. (P=0.05) with a 2-sided a error of 5% and power of 80%, a total sample size of 37 total was required.
- Statistical Analyses:
SPSS 25.0 (IBM Corporation, Armonk, New York, United States) and PAST 3 (Hammer, Ø., Harper, D.A.T., Ryan, P.D. 2001. Paleontological statistics) programs were used in the analysis of the variables. The conformity of univariate data to normal distribution was evaluated with the Shapiro-Wilk francia test, while homogeneity of variance was evaluated with the Levene test. Mardia for the conformity of multivariate data to normal distribution; while the (Dornik and Hansen omnibus) test was used, the Box-M test was used for variance homogeneity. In the comparison of more than two groups according to quantitative data, Fisher's Least Significant Difference (LSD) tests were used for One-Way Anova post hoc analysis, one of the parametric methods, Kruskal-Wallis H Test, which is one of the nonparametric tests, was used with the results of Monte Carlo simulation technique, and Dunn's Test was used for Post Hoc analyses. The Paired-Samples T test was tested using Bootstrap results, while the Wilcoxon Signed Ranks Test was tested using the monte carlo simulation method to compare two replicate measurements of dependent quantitative variables with each other. While Friedman's Two-Way test was tested using the monte carlo simulation method to test the variables with more than two repeated measurements and to examine the interaction according to the groups, the General Linear Model-Repeated Anova test from parametric methods was used, and the LSD test was used for Post Hoc analyses. In the comparison of categorical variables with each other, Fisher-Freeman-Holton test was tested with Monte Carlo Simulation technique. While quantitative variables were expressed as mean (standard deviation) and Median (Percentile 25 / Percentile 75) in the tables, categorical variables were shown as n (%). The variables were analyzed at 95% confidence level, and a p value less than 0.05 was considered significant.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| supine | – | Other: vital signs by postpartum positionsupine position: Evaluation position for the first 10 minutes after birth |
| right-side | – | Other: vital signs by postpartum positionright-side position: Evaluation position for the first 10 minutes after birth |
| left-side | – | Other: vital signs by postpartum positionleft-side position: Evaluation position for the first 10 minutes after birth |
| prone | – | Other: vital signs by postpartum positionprone position: Evaluation position for the first 10 minutes after birth |
Who may qualify
- Ages
- 2 to 10 minutes
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- newborn
Key inclusion criteria (1 listed)
- born with cesarean sectio (CS) could not exposed to early skin-to-skin contact
Key exclusion criteria (1 listed)
- Vaginal birth
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 |
|---|---|---|
| vital signs by postpartum positionEvaluation of vital signs and NIRS values in 4 different positions after birth | Other | left-side, prone, right-side, supine |
Primary outcome
near infrared spectroscopy (NIRS) for each position at delivery room
Time frame: 10 minutes
near infrared spectroscopy
fractional oxygean extraction (FOE) for each position at delivery room
Time frame: 10 minutes
fractional oxygean extraction
postnatal adaptation on vital parameters as heart rate for each position at delivery room
Time frame: 10 minutes
heart rate
postnatal adaptation on vital parameters as pulseoximeter for each position at delivery room
Time frame: 10 minutes
pulseoximeter
postnatal adaptation on vital parameters as perfusion index for each position at delivery room
Time frame: 10 minutes
perfusion index
Apgar scores for each position at delivery roomat delivery room
Time frame: 5 minutes
apgar scores
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 22 May 2023.
- Results publication: PubMed 1489116Mutoh T, Guest RJ, Lamm WJ, Albert RK. Prone position alters the effect of volume overload on regional pleural pressures and improves hypoxemia in pigs in vivo. Am Rev Respir Dis. 1992 Aug;146(2):300-6. doi: 10.1164/ajrccm/146.2.300.
- Results publication: PubMed 17906392Hou X, Ding H, Teng Y, Zhou C, Tang X, Li S, Ding H. Research on the relationship between brain anoxia at different regional oxygen saturations and brain damage using near-infrared spectroscopy. Physiol Meas. 2007 Oct;28(10):1251-65. doi: 10.1088/0967-3334/28/10/010. Epub 2007 Sep 28.
- Results publication: PubMed 10331341Brodsky JB. What intraoperative monitoring makes sense? Chest. 1999 May;115(5 Suppl):101S-105S. doi: 10.1378/chest.115.suppl_2.101s.
- Results publication: PubMed 20497559Baikoussis NG, Karanikolas M, Siminelakis S, Matsagas M, Papadopoulos G. Baseline cerebral oximetry values in cardiac and vascular surgery patients: a prospective observational study. J Cardiothorac Surg. 2010 May 24;5:41. doi: 10.1186/1749-8090-5-41.
- Results publication: PubMed 11020747Samra SK, Dy EA, Welch K, Dorje P, Zelenock GB, Stanley JC. Evaluation of a cerebral oximeter as a monitor of cerebral ischemia during carotid endarterectomy. Anesthesiology. 2000 Oct;93(4):964-70. doi: 10.1097/00000542-200010000-00015.
- Results publication: PubMed 17377413Naulaers G, Meyns B, Miserez M, Leunens V, Van Huffel S, Casaer P, Weindling M, Devlieger H. Use of tissue oxygenation index and fractional tissue oxygen extraction as non-invasive parameters for cerebral oxygenation. A validation study in piglets. Neonatology. 2007;92(2):120-6. doi: 10.1159/000101063. Epub 2007 Mar 23.
- Individual participant dataSharing planned: Undecided
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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.
ruya colak study chair
Dr Behçet Uz Children's Diseases and Surgery Training and Research Hospital, Neonatal Department
demet terek study chair
Ege University Faculty of Medicine, Department of Child Health and Disease, Neonatal Department
ozge altun koroglu study chair
Ege University Faculty of Medicine, Department of Child Health and Disease, Neonatal Department
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 Vital Signs, run by Dr. Behcet Uz Children's 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 22 May 2023. 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?
near infrared spectroscopy (NIRS) for each position at delivery room (time frame: 10 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05868980, which also lists 6 linked publications.
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 22 May 2023.