Clinical trial NCT02901652: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Prematurity
Respiratory Distress Syndrome
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2016-09-15
Enrollment: 325
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: surfactant requirement
timeFrame: 72 HOURS
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zekai Tahir Burak Maternity Teaching
Study officials:
affiliation: Zekai Tahir Burak Women's Health Research and Education Hospital
name: Suna Oğuz, MD
role: STUDY_DIRECTOR
References: