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

Ventilatory Failure Clinical Trial

— (NCPAP)  

Official title:

Comparison of Two Different NCPAP Methods in Preterm Infants With Respiratory Distress Syndrome With Gestational Age of 26-30 Weeks

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03400670
• Other study ID #: 02082019
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2017
• Est. completion date: February 5, 2020

Study information

• Verified date: January 2017
• Source: Zekai Tahir Burak Women's Health Research and Education Hospital
• Contact: Mehmet Büyüktiryaki, MD
• Phone: +905054525576
• Email: mbuyuktiryaki[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: February 5, 2020
• Est. primary completion date: January 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Hours

Eligibility

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

Related Conditions & MeSH terms

• Hypoventilation
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Ventilatory Failure

Intervention

Device:
• ventilator NCPAP
infants will be randomized into two different NCPAP groups

Locations

Country	Name	City	State
Turkey	Zekai Tahir Burak Maternity Teaching	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Zekai Tahir Burak Women's Health Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	noninvasive ventilation failure	need for mechanical ventilation in the first 72 hours of life	72 hours