NIPPV and nBiPAP Methods in Preterm Infants With Respiratory Distress Syndrome

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

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.

Study Overview

• Status: Unknown
• Conditions: Respiratory Distress Syndrome; Prematurity
• Intervention / Treatment: Device: noninvasive respiratory support devices

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.

• Study Type: Interventional
• Enrollment (Anticipated): 325
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Suna Oguz, MD; Phone Number: +90 3123065270; Email: serifesuna@gmail.com

Study Locations

• Turkey
  • Ankara, Turkey, 06230
    • Recruiting
    • Zekai Tahir Burak Maternity Teaching

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 3 days (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 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 Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
surfactant requirement	surfactant requirement within 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, MD, Zekai Tahir Burak Women's Health Research and Education Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): September 30, 2019

Study Registration Dates

• First Submitted: August 2, 2016
• First Submitted That Met QC Criteria: September 10, 2016
• First Posted (Estimate): September 15, 2016

Study Record Updates

• Last Update Posted (Actual): July 18, 2019
• Last Update Submitted That Met QC Criteria: July 15, 2019
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: 02082016