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

Not Applicable

• Conditions: Ventilatory Failure
• Interventions: Device: ventilator NCPAP

• Registration Number: NCT03400670
• Lead Sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2017-01
• Study Start: 2017-01-05
• Study First Submitted: 2017-12-11
• Study First Submitted QC: 2018-01-13
• Study First Posted: 2018-01-17
• Last Update Submitted: 2019-07-15
• Last Update Posted: 2019-07-16
• Primary Completion: 2020-01-05
• Study Completion: 2020-02-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ventilator NCPAP	ventilator NCPAP	neonatal ventilator (SLE; Specialised Laboratory Equipment, UK) PEEP: 5 cmH2O
Infant Flow-driver NCPAP	ventilator NCPAP	infant flow-driver device (Infant Flow System, Viasys Corp., USA) PEEP:5-8 cmH2O, This group receive variable flow

Primary Outcome Measures

Name	Time	Method
noninvasive ventilation failure	72 hours	need for mechanical ventilation in the first 72 hours of life

Trial Locations

Locations (1)

Zekai Tahir Burak Maternity Teaching; 🇹🇷 Ankara, Turkey