Comparison of Two Different NCPAP Methods in Preterm Infants With Respiratory Distress Syndrome ((NCPAP))

Zekai Tahir Burak Women's Health Research and Education Hospital

Status: Unknown

Conditions: Ventilatory Failure

Treatments: Device: ventilator NCPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT03400670

02082019

Details and patient eligibility

About

is to compare introduction of two different NCPAP methods in terms of mechanical ventilation (MV) need (non-invasive respiratory support failure) and surfactant need within the first 72 hours of life in preterm infants with Respiratory Distress Syndrome (RDS) at 26-30 weeks of gestation.

Full description

Study Design NCPAP support was provided with continuous positive airway pressure, which was generated by a neonatal ventilator (SLE; Infant Flow System, Viasys Corp., USA) and infant flow-driver device (SLE; The respiratory parameter settings were a PEEP of 5-8 cmH2O. CPAP was stopped when PEEP 5 cmH2O and infants showed no signs of RDS with FiO2 <0.30.

Under non-invasive respiratory support, in case of FiO2 is ≥ 0.40, surfactant will be given as early rescue therapy by means of non-invasive method (by using a thin catheter - take care method- while spontaneous breathing continues) in order to keep target oxygen saturation between 90-95 %. The second dose of surfactant will be given 6 hours after the first dose by means on non-invasive method in order to keep target oxygen saturation between 90-95 % in case of FiO2 need is ≥ 0.30.

Non-invasive respiratory support failure is set as follows:

• FiO2 of ≥ 0.50 in order to keep oxygen saturation measured by pulse oximetry above 90 % and higher,
• Apnea requiring more than 6 alerts in a 24 -hour period in 6 consecutive hours or more than 1 apnea requiring positive pressure ventilation,
• Persistent acidosis; presence of pH < 7.20 and PCO2 > 65 mmHg in two different blood gases drawn with an interval of at least 30 minutes or treatment-resistant metabolic acidosis,
• Severe respiratory distress,
• Pulmonary haemorrhage and cardiopulmonary arrest.

Enrollment: 400 estimated patients

Sex: All

Ages: 1 to 2 hours old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Preterm infant with gestational age of 26 weeks 0 days and 29 weeks 6 days with RDS signs will be included

Exclusion criteria

• Major congenital anomalies
• Presence of cardiovascular instability
• Intubation at admission to the NICU
• Consent not provided or refused

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Ventilator NCPAP

Active Comparator group

Description:

neonatal ventilator (SLE; Specialised Laboratory Equipment, UK) PEEP: 5 cmH2O

Treatment:

Device: ventilator NCPAP

Infant Flow-driver NCPAP

Active Comparator group

Description:

infant flow-driver device (Infant Flow System, Viasys Corp., USA) PEEP:5-8 cmH2O, This group receive variable flow

Treatment:

Device: ventilator NCPAP