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Trial record 26 of 198 for:    Recruiting, Not yet recruiting, Available Studies | Neonatal respiratory distress syndrome

NIPPV and nBiPAP Methods in Preterm Infants With Respiratory Distress Syndrome

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ClinicalTrials.gov Identifier: NCT02901652
Recruitment Status : Recruiting
First Posted : September 15, 2016
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Zekai Tahir Burak Women's Health Research and Education Hospital

Brief Summary:
Purpose is to compare introduction of NIPPV (Nasal Intermittent Positive-Pressure Ventilation) and nBiPAP (Nasal Bi-level Positive Airway Pressure) 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
Prematurity Respiratory Distress Syndrome Device: noninvasive respiratory support devices Not Applicable

Detailed Description:

Purpose is to compare introduction of NIPPV and nBiPAP 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.

Method

Primary Outcome Measures:

In NIPPV and BIPAP groups, comparison of mechanical ventilation (MV) need (non-invasive respiratory support failure) and surfactant need within the first 72 hours of life

Secondary Outcome Measures:

  • Compare patients' need of total duration of invasive and non-invasive respiratory support and the duration of free oxygen
  • Compare oxygen need in postnatal day 28 and week 36
  • Compare the presence and severity of BPD (Bronchopulmonary dysplasia)
  • Compare premature morbidities such as PDA (patent ductus arteriosus), IVH (intraventricular haemorrhage), NEC (necrotizing enterocolitis), ROP (retinopathy of prematurity)
  • Compare feeding intolerance, reaching birth weight and transition to full oral feeding time, hospitalization period
  • Compare their neurodevelopment in postnatal age 2

Study Design In NIPPV group; non-synchronous mode will be used, and they will be titrated between FiO2: 021-0.50 in a respiratory rate of 20-40 / min, peak inspiratory pressure (PIP): 15-20 end-expiratory pressure (PEEP):5-6 cm H2O and target oxygen saturation: 90-95 %. In nBiPAP group; they will be titrated between 021-0.50, in non-synchronized PEEP:6 H2O, pressure amplitude: 3 cm H2O, FiO2 target oxygen saturation of 90-95 %.

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 : 325 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Nasal Intermittent Positive Airway Pressure and Nasal Bi-level Positive Airway Pressure Methods in Preterm Infants With Respiratory Distress Syndrome With Gestational Age of 26-30 Weeks
Actual Study Start Date : September 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 30, 2019


Arm Intervention/treatment
Active Comparator: NIPPV

noninvasive respiratory support devices

This group receiving Nasal Intermittent Positive Pressure Ventilation (NIPPV) treatment.

Device: noninvasive respiratory support devices
Active Comparator: BİPAP

noninvasive respiratory support devices

This group receive Bi-Level Positive Airway Pressure (BIPAP) treatment.

Device: noninvasive respiratory support devices



Primary Outcome Measures :
  1. surfactant requirement [ Time Frame: 72 HOURS ]
    surfactant requirement within the first 72 hours of life



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Ages Eligible for Study:   up to 3 Days   (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 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): NCT02901652


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

Locations
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Turkey
Zekai Tahir Burak Maternity Teaching Recruiting
Ankara, Turkey, 06230
Contact: Mehmet Buyuktiryaki, MD    +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, MD 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: NCT02901652     History of Changes
Other Study ID Numbers: 02082016
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: October 2018
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases