NIPPV and nBiPAP Methods in Preterm Infants With Respiratory Distress Syndrome

NCT ID: NCT02901652

Last Updated: 2019-07-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 325 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2019-09-30

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.

Conditions

Prematurity; Respiratory Distress Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NIPPV

noninvasive respiratory support devices

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

Group Type: ACTIVE_COMPARATOR

noninvasive respiratory support devices

Intervention Type: DEVICE

BİPAP

noninvasive respiratory support devices

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

Group Type: ACTIVE_COMPARATOR

noninvasive respiratory support devices

Intervention Type: DEVICE

Interventions

noninvasive respiratory support devices

Intervention Type: DEVICE

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

• Minimum Eligible Age: 1 Hour
• Maximum Eligible Age: 3 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zekai Tahir Burak Women's Health Research and Education Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suna Oğuz, MD

Role: STUDY_DIRECTOR

Zekai Tahir Burak Women's Health Research and Education Hospital

Locations

Zekai Tahir Burak Maternity Teaching

Ankara, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Mehmet Büyüktiryaki, MD

Role: CONTACT

mbuyuktiryaki@yahoo.com

+905054525576

Suna Oguz, MD

Role: CONTACT

serifesuna@gmail.com

+90 3123065270

Facility Contacts

Mehmet Buyuktiryaki, MD

Role: primary

mbuyuktiryaki@yahoo.com

+905054525576

Other Identifiers

02082016

Identifier Type: -

Identifier Source: org_study_id