Comparison of Two Different NCPAP Methods in Preterm Infants With

Status Recruiting

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

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

Clinical Trial Details

NCT number	NCT03400670
Study type	Interventional
Source	Zekai Tahir Burak Women's Health Research and Education Hospital
Contact	Mehmet Büyüktiryaki, MD
Phone	+905054525576
Email	mbuyuktiryaki@yahoo.com
Status	Recruiting
Phase	N/A
Start date	January 5, 2017
Completion date	February 5, 2020

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms