Respiratory DiseaseNCT06398691
Premature Newborns Treated With Less Invasive Surfactant Administration Under Heated Humidified High-flow
A study testing Nazal CPAP and Heated humidified high-flow air support with nasal cannula in people with Respiratory Disease and Newborn Rds, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Nasal Continuous Airway Pressure (CPAP) or Heated humidified high-flow Air support with nasal cannula (HHHFNC) are among the most commonly used non-invasive respiratory support methods. Read more about this study
- Who is it for?
- Ages 1 minute to 3 days
- Conditions the study is for
- Respiratory Disease, Newborn Rds
- What is being tested?
- Nazal CPAP and Heated humidified high-flow air support with nasal cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2017to 30 Dec 2017
- Phase
- Interventional
- 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 1 minute to 3 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Does not require intubation,
- Diagnosed with RDS
- Premature newborns receiving surfactant therapy in the first 72 hours of life
- Those whose families give written consent
Who cannot join
- Babies whose families do not give written consent
- Newborns diagnosed with early neonatal sepsis
- Newborns with inotropic requirements
- Neonates with hemodynamically significant PDA
- Babies of diabetic mothers
- Babies with a major congenital anomaly
Show all 11Show fewer
- Newborns with hemodynamic instability,
- Those requiring endotracheal intubation,
- NEC (Stage 2 or higher),
- Those showing ICH (Stage 2 or higher)
- Babies with perfusion disorders in the first three days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is it Possible to Premature Newborns Treated With Less Invasive Surfactant Administration Under Heated Humidified High-flow Air With Nasal Cannula?
Nasal Continuous Airway Pressure (CPAP) or Heated humidified high-flow Air support with nasal cannula (HHHFNC) are among the most commonly used non-invasive respiratory support methods. The purpose of this prospective study was to compare vital findings, blood gas parameters, perfusion index (PI) and plethysmographic variability index (PVI) values in premature infants treated with less invasive surfactant administration (LISA) under HHHFNC or CPAP.
Read the detailed description
Nasal Continuous Airway Pressure (CPAP) or Heated humidified high-flow Air support with nasal cannula (HHHFNC) are among the most commonly used non-invasive respiratory support methods. The purpose of this prospective study was to compare vital findings, blood gas parameters, perfusion index (PI) and plethysmographic variability index (PVI) values in premature infants treated with less invasive surfactant administration (LISA) under HHHFNC or CPAP. This study was carried out in Hacettepe University Hospital NICU between January and December 2017. Premature newborns who were on noninvazive respiratory support and were diagnosed as RDS within first 72 hours of life, were taken into the study. Noninvasive respiratory support was provided with nasal CPAP or HHHNFC. Pulse oxymetry measurements were obtained before and 5th, 30th, 60th, 120th , 360th minutes, blood gas analysis was performed immediately before and 120th, 360th minutes after surfactant administration.
Post-hoc, one-way difference between two independent means (two groups) statistical analysis was used. Significance P < 0.05; effect size 0.9; power (1-ß err prob) was found to be 82%.
- Conditions
- Respiratory Disease, Newborn Rds
- Being tested
- Nazal CPAP, Heated humidified high-flow air support with nasal cannula
- Keywords
- NEWBORN, Respiratory Distress Syndrome, Less Invasive Surfactant Administration, Heated Humidified High-Flow Air Support with Nasal Cannula., Nasal Continuous Airway Pressure
- Medical subject headings
- Respiration Disorders, Pulmonary Atelectasis, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nazal CPAPDevice
Heated humidified high-flow air support with nasal cannulaDevice
| Study group | Role | What they receive |
|---|---|---|
| CPAP group | Active comparator | A Babylog 8000 neonatal ventilator (Dräger, Lübeck, Germany) for nasal CPAP support was used support . The nasal CPAP support had been applied through short binasal prongs (Optiflow Junior 2 nasal cannula) used as an interface. PEEP pressure was set to 6-8 cmH2O for nasal CPAP. The FiO2 was regulated to keep the oxygen-saturation value between 92% and 95%. Receives: Device: Nazal CPAP |
| HHHFNC group | Active comparator | A Vapotherm® device (Vapotherm Inc., Stevensville, MD) for HHHFNC support was used. The airflow rate was set to 6-8 L/min for HHHFNC (heat: 37 °C). The HHHFNC support had been applied through the small bore cannula in the Vapotherm as an interface. The FiO2 was regulated to keep the oxygen-saturation value between 92% and 95%. Receives: Device: Heated humidified high-flow air support with nasal cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigation of the effect of surfactant treatment on the p02 value in blood gases using the LISA method in premature babies with spontaneous breathing during different respiratory support.
A total of 34 premature babies were included in the study. There were 22 patients in the CPAP group and 12 patients in the HHHFNC group. It was planned to make a comparison between CPAP and HHHNFC groups in terms of bloog gas parameters before, during and after surfactant treatment. Blood gas analysis was performed immediately before and 120th, 360th minutes after surfactant administration. p02 values in blood gas were determined according to the routine protocol of our NICU. They were performed three times: immediately before the surfactant treatment and at the 120th and 360th minute after the surfactant was administered.
Measured: 360 minutes after surfactant treatment
Secondary outcomes (1)
Investigation of the effect of using surfactant treatment with the LISA method during different respiratory support on the pulse oximetry parameters of babies.
Pulse oxymetry measurements (perfusion index and plethysmographic variability index) were obtained before and 5th, 30th, 60th, 120th , 360th minutes.Masimo Radical-7® Pulse CO-Oximetry (Masimo Corp., Irvine, CA, USA) devices were used. Pulse oximeters were attached to the right wrist of all patients during the study, and preductal measurements were made. The PI and PVI records were taken when the plethysmograph pulse wave was artefact free, while the baby was calm. All vital findings were noted simultaneously. The measurements recorded for six hours after the surfactant administration were transferred to a personal computer and analyzed with the VitaWin 3 (Telematya Germany, Teltow, Germany) program.
Measured: 360 minutes after surfactant treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start10 Jan 2017
- Primary completion23 Nov 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Respiratory DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Premature newborns (gestational age \<370/7 weeks) who did not require intubation, who were diagnosed with RDS, and who were treated with surfactant in the first 72 hours of life were included in the study. Written informed consent was obtained from all of the infants' families before the infants were enrolled in the study. Noninvasive respiratory support was provided by nasal CPAP or HHHNFC, respectively, according to the time of admission to the intensive-care unit, so the patients were divided into two groups. During the study period, the noninvasive respiratory support method (nasal CPAP or HHHNFC) that the babies received did not change. Post-hoc, one-way difference between two independent means (two groups) statistical analysis was used. Significance P \< 0.05; effect size 0.9; power (1-ß err prob) was found to be 82%.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MELEK BUYUKEREN, Hacettepe University
- Investigators
- MELEK BUYUKEREN, Study director, Hacettepe University, Neonatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398691
- Sponsor's protocol ID
- HU-MB-1
- Status last verified
- May 2024
- First submitted
- 15 Mar 2024
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol, statistical analysis plan, clinical study report
Publications
Morley CJ, Davis PG, Doyle LW, Brion LP, Hascoet JM, Carlin JB; COIN Trial Investigators. Nasal CPAP or intubation at birth for very preterm infants. N Engl J Med. 2008 Feb 14;358(7):700-8. doi: 10.1056/NEJMoa072788.
PubMed 18272893Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Plavka R, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GH, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2016 Update. Neonatology. 2017;111(2):107-125. doi: 10.1159/000448985. Epub 2016 Sep 21.
PubMed 27649091Chao KY, Chen YL, Tsai LY, Chien YH, Mu SC. The Role of Heated Humidified High-flow Nasal Cannula as Noninvasive Respiratory Support in Neonates. Pediatr Neonatol. 2017 Aug;58(4):295-302. doi: 10.1016/j.pedneo.2016.08.007. Epub 2017 Jan 17.
PubMed 28223010
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is it Possible to Premature Newborns Treated With Less Invasive Surfactant Administration Under Heated Humidified High-flow Air With Nasal Cannula?
- ClinicalTrials.gov ID
- NCT06398691
- Acronym / sponsor ID
- HU-MB-1
- Conditions
- Respiratory Disease, Newborn Rds
- Keywords
- NEWBORN, Respiratory Distress Syndrome, Less Invasive Surfactant Administration, Heated Humidified High-Flow Air Support with Nasal Cannula., Nasal Continuous Airway Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 10 Jan 2017 (actual)
- Primary completion
- 23 Nov 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 3 May 2024 (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.
Nasal Continuous Airway Pressure (CPAP) or Heated humidified high-flow Air support with nasal cannula (HHHFNC) are among the most commonly used non-invasive respiratory support methods. The purpose of this prospective study was to compare vital findings, blood gas parameters, perfusion index (PI) and plethysmographic variability index (PVI) values in premature infants treated with less invasive surfactant administration (LISA) under HHHFNC or CPAP.
Detailed description
Nasal Continuous Airway Pressure (CPAP) or Heated humidified high-flow Air support with nasal cannula (HHHFNC) are among the most commonly used non-invasive respiratory support methods. The purpose of this prospective study was to compare vital findings, blood gas parameters, perfusion index (PI) and plethysmographic variability index (PVI) values in premature infants treated with less invasive surfactant administration (LISA) under HHHFNC or CPAP. This study was carried out in Hacettepe University Hospital NICU between January and December 2017. Premature newborns who were on noninvazive respiratory support and were diagnosed as RDS within first 72 hours of life, were taken into the study. Noninvasive respiratory support was provided with nasal CPAP or HHHNFC. Pulse oxymetry measurements were obtained before and 5th, 30th, 60th, 120th , 360th minutes, blood gas analysis was performed immediately before and 120th, 360th minutes after surfactant administration.
Post-hoc, one-way difference between two independent means (two groups) statistical analysis was used. Significance P < 0.05; effect size 0.9; power (1-ß err prob) was found to be 82%.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Premature newborns (gestational age <370/7 weeks) who did not require intubation, who were diagnosed with RDS, and who were treated with surfactant in the first 72 hours of life were included in the study. Written informed consent was obtained from all of the infants' families before the infants were enrolled in the study. Noninvasive respiratory support was provided by nasal CPAP or HHHNFC, respectively, according to the time of admission to the intensive-care unit, so the patients were divided into two groups. During the study period, the noninvasive respiratory support method (nasal CPAP or HHHNFC) that the babies received did not change. Post-hoc, one-way difference between two independent means (two groups) statistical analysis was used. Significance P < 0.05; effect size 0.9; power (1-ß err prob) was found to be 82%.
| Arm | Type | Receives |
|---|---|---|
| CPAP group | Active comparator | Device: Nazal CPAPA Babylog 8000 neonatal ventilator (Dräger, Lübeck, Germany) for nasal CPAP support was used support . The nasal CPAP support had been applied through short binasal prongs (Optiflow Junior 2 nasal cannula) used as an interface. PEEP pressure was set to 6-8 cmH2O for nasal CPAP. The FiO2 was regulated to keep the oxygen-saturation value between 92% and 95%. |
| HHHFNC group | Active comparator | Device: Heated humidified high-flow air support with nasal cannulaA Vapotherm® device (Vapotherm Inc., Stevensville, MD) for HHHFNC support was used. The airflow rate was set to 6-8 L/min for HHHFNC (heat: 37 °C). The HHHFNC support had been applied through the small bore cannula in the Vapotherm as an interface. The FiO2 was regulated to keep the oxygen-saturation value between 92% and 95%. |
Who may qualify
- Ages
- 1 minute to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Does not require intubation,
- Diagnosed with RDS
- Premature newborns receiving surfactant therapy in the first 72 hours of life
- Those whose families give written consent
Key exclusion criteria (11 listed)
- Babies whose families do not give written consent
- Newborns diagnosed with early neonatal sepsis
- Newborns with inotropic requirements
- Neonates with hemodynamically significant PDA
- Babies of diabetic mothers
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 |
|---|---|---|
| Nazal CPAP | Device | CPAP group |
| Heated humidified high-flow air support with nasal cannula | Device | HHHFNC group |
Primary outcome
Investigation of the effect of surfactant treatment on the p02 value in blood gases using the LISA method in premature babies with spontaneous breathing during different respiratory support.
Time frame: 360 minutes after surfactant treatment
A total of 34 premature babies were included in the study. There were 22 patients in the CPAP group and 12 patients in the HHHFNC group. It was planned to make a comparison between CPAP and HHHNFC groups in terms of bloog gas parameters before, during and after surfactant treatment. Blood gas analysis was performed immediately before and 120th, 360th minutes after surfactant administration. p02 values in blood gas were determined according to the routine protocol of our NICU. They were performed three times: immediately before the surfactant treatment and at the 120th and 360th minute after the surfactant was administered.
1 secondary outcome
Investigation of the effect of using surfactant treatment with the LISA method during different respiratory support on the pulse oximetry parameters of babies.
Time frame: 360 minutes after surfactant treatment
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 3 May 2024.
- Results publication: PubMed 18272893Morley CJ, Davis PG, Doyle LW, Brion LP, Hascoet JM, Carlin JB; COIN Trial Investigators. Nasal CPAP or intubation at birth for very preterm infants. N Engl J Med. 2008 Feb 14;358(7):700-8. doi: 10.1056/NEJMoa072788.
- Results publication: PubMed 27649091Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Plavka R, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GH, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2016 Update. Neonatology. 2017;111(2):107-125. doi: 10.1159/000448985. Epub 2016 Sep 21.
- Results publication: PubMed 28223010Chao KY, Chen YL, Tsai LY, Chien YH, Mu SC. The Role of Heated Humidified High-flow Nasal Cannula as Noninvasive Respiratory Support in Neonates. Pediatr Neonatol. 2017 Aug;58(4):295-302. doi: 10.1016/j.pedneo.2016.08.007. Epub 2017 Jan 17.
- Individual participant dataSharing planned: Yes. Study protocol, statistical analysis plan, clinical study report
Related trials for Respiratory Disease
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
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.
MELEK BUYUKEREN study director
Hacettepe University, Neonatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nazal CPAP and Heated humidified high-flow air support with nasal cannula in people with Respiratory Disease and Newborn Rds, 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 4 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: finished, as of the sponsor's last update on 3 May 2024. 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?
Investigation of the effect of surfactant treatment on the p02 value in blood gases using the LISA method in premature babies with spontaneous breathing during different respiratory support. (time frame: 360 minutes after surfactant treatment). 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 NCT06398691, which also lists 3 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 3 May 2024.