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

Hacettepe University

Status: Completed

Conditions: Respiratory Disease; Newborn Rds

Treatments: Device: Heated humidified high-flow air support with nasal cannula; Device: Nazal CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT06398691

HU-MB-1

Details and patient eligibility

About

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.

Full 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%.

Enrollment: 34 patients

Sex: All

Ages: 1 minute to 3 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

CPAP group

Active Comparator group

Description:

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%.

Treatment:

Device: Nazal CPAP

HHHFNC group

Active Comparator group

Description:

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%.

Treatment:

Device: Heated humidified high-flow air support with nasal cannula