Premature BirthTCOPHCNCT04505176
Comparison of the Results of Transcutaneous Carbon Dioxide and Oxygen Pressure in Premature Neonates Who Underwent MIST Under HHHFNC or Nasal CPAP Methods
An observational study of Premature Birth and Respiratory Distress Syndrome, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Intratracheal surfactant treatment is applied in Respiratory Distress Syndrome (RDS) Continious Positive Airway Pressure(CPAP) treatment. In recent clinical studies, two similar methods have been studied with a thin catheter without endotracheal intubation in the application of surfactant. Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Premature Birth, Respiratory Distress Syndrome, Surfactant Deficiency Syndrome Neonatal
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2020to 30 Nov 2021
- How long will I take part?
- 12 Months
- 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 28 days
- All sexes
- No healthy volunteers
- Child
Study population: it was planned to take a total of 40 patients born under 32 weeks and less than 1500 grams
Who may be able to join
- Premature babies under 37 weeks of sleep at Hacettepe University Neonatal Intensive Care Unit,
- Infants who have been diagnosed with respiratory distress syndrome in the first 24 hours of life, who have received surfactant treatment under the nCPAP or HHHFNC method using the MIST method,
- Babies whose informed consent was obtained from their mothers and / or fathers
Who cannot join
- Term babies born 37 weeks and over
- Babies monitored for intubation due to severe respiratory failure
- Babies with hemodynamically unstable, severe hypotension
- Major congenital anomalies (severe congenital heart disease, congenital diaphragmatic hernia etc.)
- Babies with chromosomal disorders
- Babies with hereditary metabolic disease
Show all 11Show fewer
- Babies whose informed consent form could not be obtained from their mothers and / or fathers
- Babies whose mothers have early membrane rupture or chorioamnionitis
- Diabetic mother babies
- Families who want their children to leave the work at any time of the study
- Babies whose study data cannot be collected completely
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Results of Transcutaneous Carbon Dioxide and Oxygen Pressure in Premature Neonates Who Underwent Minimally Invasive Surfactant Therapy (MIST) Under Heated Respiratory Support With Nasal Cannula High Flow Air Support (HHHFNC) or Nasal Continuous Airway Pressure (CPAP) Methods
Intratracheal surfactant treatment is applied in Respiratory Distress Syndrome (RDS) Continious Positive Airway Pressure(CPAP) treatment. In recent clinical studies, two similar methods have been studied with a thin catheter without endotracheal intubation in the application of surfactant.
In our neonatal intensive care unit, respiratory support is given with nasal CPAP and Humidified Heated High Flow Nasal Cannula (HHHFNC) instead of classical invasive (intubated) mechanical ventilation methods. In CPAP method, heated and humidified air is given a certain pressure (6-8 cmH2O), while in HHHFNC method, heated humidified air is given at a certain flow rate (6-8 L / min). This study was planned to compare the results of infants who were given surfactant with MIST (Minimal Invazive Surfactant Treatment) method under CPAP or HHHFNC support in the treatment of respiratory distress syndrome in premature babies.
Read more
During surfactant application, babies will be monitored (as in all babies in the NICU) saturation, peak heart rate, perfusion index (the ratio of nonpulsatile flow in the capillary bed) and t values will be recorded. For all these reasons, monitoring of PI (Perfusion Index), PVI (plethysmographic variability index) and continuous transcutaneous PCO2 and PO2 values are of great importance for the prevention of mortality and morbidity, as well as monitoring of oxygen saturation values with pulse oximetry in premature babies.
In our hospital, it was planned to take a total of 40 patients born under 32 weeks and less than 1500 grams (20 patients being in the HHHNFC, 20 patients in the CPAP group). Patients will be consecutively distributed to two groups until they reach the specified number of patients.
In this study, it was aimed to monitor continuous oxygen saturation, PI, PVI, transcutaneous PO2 and PCO2 measurements just before, during and after the surfactant application and to compare the results of babies who received nCPAP and HHHFNC support.
At the end of the study, all data will be entered in an SPSS (Statistical Package for the Social Sciences) file and study statistics will be made. A database will be created using SPSS software. A p value of <0.05 was determined as the limit of significance.
Read the detailed description
In premature babies (born before 37th week of pregnancy), surfactant production is insufficient since lung maturation has not been completed yet. Accordingly, surface tension increases in alveoli and it is difficult to keep the alveoli open, gas exchange is insufficient, and as a result, respiratory distress syndrome (RDS) occurs in premature babies. Severe respiratory failure occurs in the baby, it must be connected to the mechanical ventilator, even if hypoxia cannot be corrected, the baby may be lost. Intratracheal surfactant treatment is applied in the treatment of respiratory distress syndrome, which develops due to surfactant deficiency. With surfactant treatment, death due to RDS, mechanical ventilation requirement, morbidity due to lung disease, hospitalization times in neonatal intensive care units have been reduced and survival rates of premature babies have increased.
Intraracheal surfactant treatment is applied in RDS treatment. In recent clinical studies, two similar methods have been studied with a thin catheter without endotracheal intubation in the application of surfactant. One of these methods; Developed in Germany, it is LISA (the application of surfactant, which is less invasive), which is currently widely used in Europe. In the LISA(Less invasive surfactant administration) method, surfactant is given after placing a thin flexible catheter into the trachea with the help of a laryngoscope (Magill's forceps may or may not be used) while the baby is in CPAP. The second method is the application of surfactant, which was developed in Australia and given by using a hard thin vascular catheter into the trachea while the baby is being followed up in CPAP only under direct laryngoscope without using forceps. This method is called MIST (minimally invasive surfactant treatment). In both methods, the aim is to give the surfactant warmed up to body temperature slowly in a few minutes with the help of an injector in a baby with spontaneous breathing under CPAP.
In the current RDS review (2019), it was emphasized that noninvasive respiratory support is the most appropriate way to support the breathing of preterm infants. Non invasive methods; CPAP is specified as bi-level CPAP, HHHFNC, positive pressure ventilation with nasal interval. CPAP devices provide gas flow under controlled pressure with probes firmly placed in the nose. Through the distension pressure; Supporting the opening of the upper airway, continued lung expansion and prevention of end-expiratory alveolar collapse (lung closure at the end of breath). Thus, it is easier to release the endogenous surfactant.
Heated high flow air support (HHHFNC) moistened with nasal cannula; It has been used as an alternative to nasal CPAP since 2013 RDS guideline. The utility mechanism allows the removal of carbon dioxide in the nasopharyngeal area, provides the anatomical dead space to be washed with air flow, reduces the disadvantage of the anatomical dead space. It also provides CPAP-like support thanks to its high flow rates. It reduces breathing work. It helps to reduce the FiO2 level, typically using a flow rate of 4-8 L / min.
According to the RDS review updated in 2019, early surfactant should be applied in infants with RDS. According to the latest recommendation, surfactant should be given if the baby's FiO2 (fraction of inspired oxygen) need is over 30%.
In our neonatal intensive care unit, respiratory support is given with nasal CPAP and HHHFNC instead of classical invasive (intubated) mechanical ventilation methods. In CPAP method, heated and humidified air is given a certain pressure (6-8 cmH2O), while in HHHFNC method, heated humidified air is given at a certain flow rate (6-8 L / min). This study was planned to compare the results of infants who were given surfactant with MIST method under CPAP or HHHFNC support in the treatment of respiratory distress syndrome in premature babies. No blood will be collected from the babies included in this study, and nothing that will not be applied to babies who are not included in the study. If these babies need surfactant according to the chest X-ray and oxygen demand in the breathing air, surfactant support will be given by MIST method. In the follow-up of these babies, after the surfactant application, the follow-up application for each baby will be carried out; Blood gas will be taken in the second and sixth hour, and a chest radiograph will be taken in the sixth hour. The mechanical ventilation settings of the patient are made according to the values here. For example, the pressure given in case of insufficient oxygenation, the amount of oxygen is increased, the pressure given in case of hypercarbia is increased, the pressure is decreased in case of hypocarbia.
This measurement shows only partial carbon dioxide (PCO2) and partial oxygen (PO2) pressures in that instant blood gas. It is of great importance to protect the premature babies being monitored in the intensive care unit from hypoxia and hypercarbia, as well as the pressure, volume, oxygen-related trauma and injuries given by iatrogenically invasive or non-invasive respiratory support. Unnecessarily high supply of oxygen can cause oxygen radical damage and increase the risk of diseases associated with oxygen radical damage (premature retinopathy, necrotizing enterocolitis, bronchopulmonary dysplasia, periventricular leukomalacia). With the improvement of lung compliance and recovery of gas after surfactant treatment, carbon dioxide excretion may accelerate and hypocarbia may develop. Hypocarbia can cause intraventricular hemorrhage and periventricular leukomalacia in premature babies.
During surfactant application, babies will be monitored (as in all babies in the NICU) saturation, peak heart rate, perfusion index (the ratio of nonpulsatile flow in the capillary bed) and t values will be recorded. For all these reasons, monitoring of PI, PVI and continuous transcutaneous PCO2 and PO2 values are of great importance for the prevention of mortality and morbidity, as well as monitoring of oxygen saturation values with pulse oximetry in premature babies.
Research Method:
In our hospital, it was planned to take a total of 40 patients born under 32 weeks and less than 1500 grams (20 patients being in the HHHNFC, 20 patients in the CPAP group). Patients will be consecutively distributed to two groups until they reach the specified number of patients.
In this study, it was aimed to monitor continuous oxygen saturation, PI, PVI, transcutaneous PO2 and PCO2 measurements just before, during and after the surfactant application and to compare the results of babies who received nCPAP and HHHFNC support.
At the end of the study, all data will be entered in an SPSS file and study statistics will be made. A database will be created using SPSS software. A p value of <0.05 was determined as the limit of significance.
- Keywords
- surfactant therapy, prematurity, transcutaneous measurement
- Medical subject headings
- Premature Birth, Respiratory Distress Syndrome, Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | 20 patients being in the HHHNFC. In this study, it was aimed to monitor continuous oxygen saturation, PI, PVI, transcutaneous PO2 and PCO2 measurements just before, during and after the surfactant application and to compare the results of babies who received nCPAP and HHHFNC support. | |
| 2 | 20 patients in the CPAP group. In this study, it was aimed to monitor continuous oxygen saturation, PI, PVI, transcutaneous PO2 and PCO2 measurements just before, during and after the surfactant application and to compare the results of babies who received nCPAP and HHHFNC support. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the Results of Transcutaneous Oxygen Pressure
In this study, it was aimed to monitor continuous transcutaneous PO2 measurements just before, during and after the surfactant application and to compare the results of babies who received nCPAP and HHHFNC support.
Measured: 12 months
Comparison of the Results of Transcutaneous Carbon dioxide Pressure
In this study, it was aimed to monitor continuous transcutaneous PCO2 measurements just before, during and after the surfactant application and to compare the results of babies who received nCPAP and HHHFNC support.
Measured: 12months
Secondary outcomes (1)
Comparison of the Results of Saturation Values
In this study, it was aimed to monitor saturation measurements just before, during and after the surfactant application and to compare the results of babies who received nCPAP and HHHFNC support.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start30 Nov 2020 (estimated)
- Primary completion30 Nov 2021 (estimated)
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, H. Tolga Çelik, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04505176
- Sponsor's protocol ID
- KA-19071
- Acronym
- TCOPHC
- Status last verified
- Aug 2020
- First submitted
- 1 Aug 2020
- Last updated
- 10 Aug 2020
- 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 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Results of Transcutaneous Carbon Dioxide and Oxygen Pressure in Premature Neonates Who Underwent Minimally Invasive Surfactant Therapy (MIST) Under Heated Respiratory Support With Nasal Cannula High Flow Air Support (HHHFNC) or Nasal Continuous Airway Pressure (CPAP) Methods
- ClinicalTrials.gov ID
- NCT04505176
- Acronym / sponsor ID
- TCOPHC / KA-19071
- Keywords
- surfactant therapy, prematurity, transcutaneous measurement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 30 Nov 2020 (estimated)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 10 Aug 2020 (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.
Intratracheal surfactant treatment is applied in Respiratory Distress Syndrome (RDS) Continious Positive Airway Pressure(CPAP) treatment. In recent clinical studies, two similar methods have been studied with a thin catheter without endotracheal intubation in the application of surfactant.
In our neonatal intensive care unit, respiratory support is given with nasal CPAP and Humidified Heated High Flow Nasal Cannula (HHHFNC) instead of classical invasive (intubated) mechanical ventilation methods. In CPAP method, heated and humidified air is given a certain pressure (6-8 cmH2O), while in HHHFNC method, heated humidified air is given at a certain flow rate (6-8 L / min). This study was planned to compare the results of infants who were given surfactant with MIST (Minimal Invazive Surfactant Treatment) method under CPAP or HHHFNC support in the treatment of respiratory distress syndrome in premature babies.
During surfactant application, babies will be monitored (as in all babies in the NICU) saturation, peak heart rate, perfusion index (the ratio of nonpulsatile flow in the capillary bed) and t values will be recorded. For all these reasons, monitoring of PI (Perfusion Index), PVI (plethysmographic variability index) and continuous transcutaneous PCO2 and PO2 values are of great importance for the prevention of mortality and morbidity, as well as monitoring of oxygen saturation values with pulse oximetry in premature babies.
In our hospital, it was planned to take a total of 40 patients born under 32 weeks and less than 1500 grams (20 patients being in the HHHNFC, 20 patients in the CPAP group). Patients will be consecutively distributed to two groups until they reach the specified number of patients.
In this study, it was aimed to monitor continuous oxygen saturation, PI, PVI, transcutaneous PO2 and PCO2 measurements just before, during and after the surfactant application and to compare the results of babies who received nCPAP and HHHFNC support.
At the end of the study, all data will be entered in an SPSS (Statistical Package for the Social Sciences) file and study statistics will be made. A database will be created using SPSS software. A p value of <0.05 was determined as the limit of significance.
Detailed description
In premature babies (born before 37th week of pregnancy), surfactant production is insufficient since lung maturation has not been completed yet. Accordingly, surface tension increases in alveoli and it is difficult to keep the alveoli open, gas exchange is insufficient, and as a result, respiratory distress syndrome (RDS) occurs in premature babies. Severe respiratory failure occurs in the baby, it must be connected to the mechanical ventilator, even if hypoxia cannot be corrected, the baby may be lost. Intratracheal surfactant treatment is applied in the treatment of respiratory distress syndrome, which develops due to surfactant deficiency. With surfactant treatment, death due to RDS, mechanical ventilation requirement, morbidity due to lung disease, hospitalization times in neonatal intensive care units have been reduced and survival rates of premature babies have increased.
Intraracheal surfactant treatment is applied in RDS treatment. In recent clinical studies, two similar methods have been studied with a thin catheter without endotracheal intubation in the application of surfactant. One of these methods; Developed in Germany, it is LISA (the application of surfactant, which is less invasive), which is currently widely used in Europe. In the LISA(Less invasive surfactant administration) method, surfactant is given after placing a thin flexible catheter into the trachea with the help of a laryngoscope (Magill's forceps may or may not be used) while the baby is in CPAP. The second method is the application of surfactant, which was developed in Australia and given by using a hard thin vascular catheter into the trachea while the baby is being followed up in CPAP only under direct laryngoscope without using forceps. This method is called MIST (minimally invasive surfactant treatment). In both methods, the aim is to give the surfactant warmed up to body temperature slowly in a few minutes with the help of an injector in a baby with spontaneous breathing under CPAP.
In the current RDS review (2019), it was emphasized that noninvasive respiratory support is the most appropriate way to support the breathing of preterm infants. Non invasive methods; CPAP is specified as bi-level CPAP, HHHFNC, positive pressure ventilation with nasal interval. CPAP devices provide gas flow under controlled pressure with probes firmly placed in the nose. Through the distension pressure; Supporting the opening of the upper airway, continued lung expansion and prevention of end-expiratory alveolar collapse (lung closure at the end of breath). Thus, it is easier to release the endogenous surfactant.
Heated high flow air support (HHHFNC) moistened with nasal cannula; It has been used as an alternative to nasal CPAP since 2013 RDS guideline. The utility mechanism allows the removal of carbon dioxide in the nasopharyngeal area, provides the anatomical dead space to be washed with air flow, reduces the disadvantage of the anatomical dead space. It also provides CPAP-like support thanks to its high flow rates. It reduces breathing work. It helps to reduce the FiO2 level, typically using a flow rate of 4-8 L / min.
According to the RDS review updated in 2019, early surfactant should be applied in infants with RDS. According to the latest recommendation, surfactant should be given if the baby's FiO2 (fraction of inspired oxygen) need is over 30%.
In our neonatal intensive care unit, respiratory support is given with nasal CPAP and HHHFNC instead of classical invasive (intubated) mechanical ventilation methods. In CPAP method, heated and humidified air is given a certain pressure (6-8 cmH2O), while in HHHFNC method, heated humidified air is given at a certain flow rate (6-8 L / min). This study was planned to compare the results of infants who were given surfactant with MIST method under CPAP or HHHFNC support in the treatment of respiratory distress syndrome in premature babies. No blood will be collected from the babies included in this study, and nothing that will not be applied to babies who are not included in the study. If these babies need surfactant according to the chest X-ray and oxygen demand in the breathing air, surfactant support will be given by MIST method. In the follow-up of these babies, after the surfactant application, the follow-up application for each baby will be carried out; Blood gas will be taken in the second and sixth hour, and a chest radiograph will be taken in the sixth hour. The mechanical ventilation settings of the patient are made according to the values here. For example, the pressure given in case of insufficient oxygenation, the amount of oxygen is increased, the pressure given in case of hypercarbia is increased, the pressure is decreased in case of hypocarbia.
This measurement shows only partial carbon dioxide (PCO2) and partial oxygen (PO2) pressures in that instant blood gas. It is of great importance to protect the premature babies being monitored in the intensive care unit from hypoxia and hypercarbia, as well as the pressure, volume, oxygen-related trauma and injuries given by iatrogenically invasive or non-invasive respiratory support. Unnecessarily high supply of oxygen can cause oxygen radical damage and increase the risk of diseases associated with oxygen radical damage (premature retinopathy, necrotizing enterocolitis, bronchopulmonary dysplasia, periventricular leukomalacia). With the improvement of lung compliance and recovery of gas after surfactant treatment, carbon dioxide excretion may accelerate and hypocarbia may develop. Hypocarbia can cause intraventricular hemorrhage and periventricular leukomalacia in premature babies.
During surfactant application, babies will be monitored (as in all babies in the NICU) saturation, peak heart rate, perfusion index (the ratio of nonpulsatile flow in the capillary bed) and t values will be recorded. For all these reasons, monitoring of PI, PVI and continuous transcutaneous PCO2 and PO2 values are of great importance for the prevention of mortality and morbidity, as well as monitoring of oxygen saturation values with pulse oximetry in premature babies.
Research Method:
In our hospital, it was planned to take a total of 40 patients born under 32 weeks and less than 1500 grams (20 patients being in the HHHNFC, 20 patients in the CPAP group). Patients will be consecutively distributed to two groups until they reach the specified number of patients.
In this study, it was aimed to monitor continuous oxygen saturation, PI, PVI, transcutaneous PO2 and PCO2 measurements just before, during and after the surfactant application and to compare the results of babies who received nCPAP and HHHFNC support.
At the end of the study, all data will be entered in an SPSS file and study statistics will be made. A database will be created using SPSS software. A p value of <0.05 was determined as the limit of significance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –20 patients being in the HHHNFC. In this study, it was aimed to monitor continuous oxygen saturation, PI, PVI, transcutaneous PO2 and PCO2 measurements just before, during and after the surfactant application and to compare the results of babies who received nCPAP and HHHFNC support. |
| 2 | – | –20 patients in the CPAP group. In this study, it was aimed to monitor continuous oxygen saturation, PI, PVI, transcutaneous PO2 and PCO2 measurements just before, during and after the surfactant application and to compare the results of babies who received nCPAP and HHHFNC support. |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- it was planned to take a total of 40 patients born under 32 weeks and less than 1500 grams
Key inclusion criteria (3 listed)
- Premature babies under 37 weeks of sleep at Hacettepe University Neonatal Intensive Care Unit,
- Infants who have been diagnosed with respiratory distress syndrome in the first 24 hours of life, who have received surfactant treatment under the nCPAP or HHHFNC method using the MIST method,
- Babies whose informed consent was obtained from their mothers and / or fathers
Key exclusion criteria (11 listed)
- Term babies born 37 weeks and over
- Babies monitored for intubation due to severe respiratory failure
- Babies with hemodynamically unstable, severe hypotension
- Major congenital anomalies (severe congenital heart disease, congenital diaphragmatic hernia etc.)
- Babies with chromosomal disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of the Results of Transcutaneous Oxygen Pressure
Time frame: 12 months
In this study, it was aimed to monitor continuous transcutaneous PO2 measurements just before, during and after the surfactant application and to compare the results of babies who received nCPAP and HHHFNC support.
Comparison of the Results of Transcutaneous Carbon dioxide Pressure
Time frame: 12months
In this study, it was aimed to monitor continuous transcutaneous PCO2 measurements just before, during and after the surfactant application and to compare the results of babies who received nCPAP and HHHFNC support.
1 secondary outcome
Comparison of the Results of Saturation Values
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2020.
- HHHFNC- premature infantLink provided by the sponsor.
- nCPAP vs HHHFNCLink provided by the sponsor.
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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 Premature Birth and Respiratory Distress Syndrome, run by Hacettepe University 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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 10 Aug 2020. 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?
Results are not available in the source record.
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?
Comparison of the Results of Transcutaneous Oxygen Pressure (time frame: 12 months). The study lists 2 primary outcomes in all. 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 10 Aug 2020.