Premature Newborns Treated With Less Invasive Surfactant Administration Under Heated Humidified High-flow
- Conditions
- Respiratory DiseaseNewborn Rds
- Interventions
- Device: Nazal CPAPDevice: Heated humidified high-flow air support with nasal cannula
- Registration Number
- NCT06398691
- Lead Sponsor
- Hacettepe University
- Brief 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. 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%.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
- 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
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CPAP group Nazal CPAP 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%. HHHFNC group Heated humidified high-flow air support with nasal cannula 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%.
- Primary Outcome Measures
Name Time Method 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. 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.
- Secondary Outcome Measures
Name Time Method Investigation of the effect of using surfactant treatment with the LISA method during different respiratory support on the pulse oximetry parameters of babies. 360 minutes after surfactant treatment 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.
Trial Locations
- Locations (1)
Melek Büyükeren
🇹🇷Ankara, Sıhhiye, Turkey