Respiratory Distress Syndrome Clinical Trial
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
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.
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.
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