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NIPPV and nBiPAP Methods in Preterm Infants With Respiratory Distress Syndrome

Primary Purpose

Prematurity, Respiratory Distress Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
noninvasive respiratory support devices
Sponsored by
Zekai Tahir Burak Women's Health Research and Education Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prematurity

Eligibility Criteria

1 Hour - 3 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zekai Tahir Burak Maternity TeachingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

NIPPV

BİPAP

Arm Description

noninvasive respiratory support devices This group receiving Nasal Intermittent Positive Pressure Ventilation (NIPPV) treatment.

noninvasive respiratory support devices This group receive Bi-Level Positive Airway Pressure (BIPAP) treatment.

Outcomes

Primary Outcome Measures

surfactant requirement
surfactant requirement within the first 72 hours of life

Secondary Outcome Measures

Full Information

First Posted
August 2, 2016
Last Updated
July 15, 2019
Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02901652
Brief Title
NIPPV and nBiPAP Methods in Preterm Infants With Respiratory Distress Syndrome
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (Actual)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
September 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity, Respiratory Distress Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
325 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NIPPV
Arm Type
Active Comparator
Arm Description
noninvasive respiratory support devices This group receiving Nasal Intermittent Positive Pressure Ventilation (NIPPV) treatment.
Arm Title
BİPAP
Arm Type
Active Comparator
Arm Description
noninvasive respiratory support devices This group receive Bi-Level Positive Airway Pressure (BIPAP) treatment.
Intervention Type
Device
Intervention Name(s)
noninvasive respiratory support devices
Primary Outcome Measure Information:
Title
surfactant requirement
Description
surfactant requirement within the first 72 hours of life
Time Frame
72 HOURS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mehmet Büyüktiryaki, MD
Phone
+905054525576
Email
mbuyuktiryaki@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Suna Oguz, MD
Phone
+90 3123065270
Email
serifesuna@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suna Oğuz, MD
Organizational Affiliation
Zekai Tahir Burak Women's Health Research and Education Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Zekai Tahir Burak Maternity Teaching
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mehmet Buyuktiryaki, MD
Phone
+905054525576
Email
mbuyuktiryaki@yahoo.com

12. IPD Sharing Statement

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NIPPV and nBiPAP Methods in Preterm Infants With Respiratory Distress Syndrome

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