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

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ClinicalTrials.gov Identifier: NCT03400670
Recruitment Status : Recruiting
First Posted : January 17, 2018
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Ventilatory Failure Device: ventilator NCPAP Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Two Different NCPAP Methods in Preterm Infants With Respiratory Distress Syndrome With Gestational Age of 26-30 Weeks
Actual Study Start Date : January 5, 2017
Estimated Primary Completion Date : January 5, 2020
Estimated Study Completion Date : February 5, 2020


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 Name: 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 Name: infant flow driver NCPAP




Primary Outcome Measures :
  1. noninvasive ventilation failure [ Time Frame: 72 hours ]
    need for mechanical ventilation in the first 72 hours of life



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Ages Eligible for Study:   up to 2 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03400670


Contacts
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Contact: Mehmet Büyüktiryaki, MD +905054525576 mbuyuktiryaki@yahoo.com
Contact: Suna Oguz +90 3123065270 serifesuna@gmail.com

Locations
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Turkey
Zekai Tahir Burak Maternity Teaching Recruiting
Ankara, Turkey, 06230
Contact: Mehmet Buyuktiryaki    +905054525576    mbuyuktiryaki@yahoo.com   
Sponsors and Collaborators
Zekai Tahir Burak Women's Health Research and Education Hospital
Investigators
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Study Director: Suna Oğuz Zekai Tahir Burak Women's Health Research and Education Hospital

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Responsible Party: Zekai Tahir Burak Women's Health Research and Education Hospital
ClinicalTrials.gov Identifier: NCT03400670     History of Changes
Other Study ID Numbers: 02082019
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zekai Tahir Burak Women's Health Research and Education Hospital:
NCPAP
Respiratory Distress Syndrome
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Tract Diseases
Infant, Newborn, Diseases
Respiratory Insufficiency
Signs and Symptoms, Respiratory
Hypoventilation
Lung Diseases
Respiration Disorders
Infant, Premature, Diseases
Signs and Symptoms