Clinical trial NCT06398691: Premature Newborns Treated With Less Invasive Surfactant Administration Under Heated Humidified High-flow
Official title: Is it Possible to Premature Newborns Treated With Less Invasive Surfactant Administration Under Heated Humidified High-flow Air With Nasal Cannula?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-05-03
Enrollment: 34
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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%.
Primary purpose: TREATMENT

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%.

Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: 360 minutes after surfactant treatment
Secondary outcomes:
measure: Investigation of the effect of using surfactant treatment with the LISA method during different respiratory support on the pulse oximetry parameters of babies.
timeFrame: 360 minutes after surfactant treatment
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Melek Büyükeren
state: Sıhhiye
Study officials:
affiliation: Hacettepe University, Neonatology
name: MELEK BUYUKEREN
role: STUDY_DIRECTOR
References:
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.
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):107-125. doi: 10.1159/000448985. Epub 2016 Sep 21.
citation: 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.