Newborn Rds, Respiratory Disease
Conditions
Keywords
NEWBORN, Respiratory Distress Syndrome, Less Invasive Surfactant Administration, Heated Humidified High-Flow Air Support with Nasal Cannula., Nasal Continuous Airway Pressure
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%.
Interventions
DEVICENazal CPAP
DEVICEHeated humidified high-flow air support with nasal cannula
Sponsors
Hacettepe University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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%.
Eligibility
Sex/Gender
ALL
Age
1 Minutes to 3 Days
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed