NIPPV and nBiPAP Methods in Preterm Infants With Respiratory Distress Syndrome

Not Applicable

• Conditions: Respiratory Distress Syndrome; Prematurity

• Registration Number: NCT02901652
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-08-02
• Study Start: 2016-09
• Study First Submitted QC: 2016-09-10
• Study First Posted: 2016-09-15
• Status Verified: 2018-10
• Last Update Submitted: 2019-07-15
• Last Update Posted: 2019-07-18
• Primary Completion: 2019-09
• Study Completion: 2019-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 325

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
surfactant requirement	72 HOURS	surfactant requirement within the first 72 hours of life

Trial Locations

Locations (1)

Zekai Tahir Burak Maternity Teaching; 🇹🇷 Ankara, Turkey