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

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

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.

Study Overview

• Status: Unknown
• Conditions: Ventilatory Failure
• Intervention / Treatment: Device: ventilator NCPAP

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 Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06230
    • Recruiting
    • Zekai Tahir Burak Maternity Teaching
    • Contact: Mehmet Buyuktiryaki; Phone Number: +905054525576; Email: mbuyuktiryaki@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 2 hours (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Ventilator NCPAP; neonatal ventilator (SLE; Specialised Laboratory Equipment, UK) PEEP: 5 cmH2O	Device: ventilator NCPAP; infants will be randomized into two different NCPAP groups; Other Names: infant flow driver NCPAP
ACTIVE_COMPARATOR: Infant Flow-driver NCPAP; infant flow-driver device (Infant Flow System, Viasys Corp., USA) PEEP:5-8 cmH2O, This group receive variable flow	Device: ventilator NCPAP; infants will be randomized into two different NCPAP groups; Other Names: infant flow driver NCPAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
noninvasive ventilation failure	need for mechanical ventilation in the first 72 hours of life	72 hours

Collaborators and Investigators

• Sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
• Investigators: Study Director: Suna Oğuz, Zekai Tahir Burak Women's Health Research and Education Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 5, 2017
• Primary Completion (ANTICIPATED): January 5, 2020
• Study Completion (ANTICIPATED): February 5, 2020

Study Registration Dates

• First Submitted: December 11, 2017
• First Submitted That Met QC Criteria: January 13, 2018
• First Posted (ACTUAL): January 17, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 16, 2019
• Last Update Submitted That Met QC Criteria: July 15, 2019
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Respiratory Distress Syndrome; NCPAP
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Hypoventilation
• Other Study ID Numbers: 02082019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No