Premature Newborns Treated With Less Invasive Surfactant Administration Under Heated Humidified High-flow

Respiratory Disease Clinical Trial

Official title:

Is it Possible to Premature Newborns Treated With Less Invasive Surfactant Administration Under Heated Humidified High-flow Air With Nasal Cannula?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06398691
• Other study ID #: HU-MB-1
• Status: Completed
• Phase: N/A
• Start date: January 10, 2017
• Est. completion date: December 30, 2017

Study information

• Verified date: May 2024
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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 information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 30, 2017
• Est. primary completion date: November 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Minute to 3 Days

Eligibility

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

Related Conditions & MeSH terms

• Newborn Rds
• Premature Birth
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases

Intervention

Device:
• Nazal CPAP

• Heated humidified high-flow air support with nasal cannula

Locations

Country	Name	City	State
Turkey	Melek Büyükeren	Ankara	Sihhiye

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Chao 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. — View Citation

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. Erratum In: N Engl J Med. 2008 Apr 3;3 — View Citation

Sweet 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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	360 minutes after surfactant treatment
Secondary	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.	360 minutes after surfactant treatment