Aerosolized surfactant in the first hour of life

Category Primary study
Registry of TrialsANZCTR
Year 2010
INTERVENTION: Nebulisation of animal derived lung surfactant commenced within the first hour of life, whilst infant supported on Constant Positive Airway Pressure (CPAP). Surfactant will be redosed by nebulisation 12 h after initial dosing if infant remains on CPAP and continues to have evidence of respiratory distress and/or oxygen requirement. Curosurf dose will be 200 mg/kg for 29 w 0 d ‐ 33 w 6 d gestation infants, and 100 mg/kg for newborns born at 34 w 0 d ‐ 39 w 6 d gestation. CONDITION: Infant Respiratory Distress Syndrome PRIMARY OUTCOME: Duration of mechanical ventilation assessed in minutes from prospective documentation. ; ; Extubation criteria:babies will be extubated at the discretion of the attending consultant with regard to oxygen requirement and clinical condition Need for intubation. ; Criteria for intubation will include one or more of the following: ; a) FiO2 > 0.35 over more than 30 minutes OR ; b) FiO2 > 0.45 at anytime, OR ; c) more than 4 apnoeas per hour OR ; d) two apnoeas requiring bag and mask ventilation, OR ; e) two capillary blood gas samples with a pH < 7.2 and pCO2 > 65 mmHg (or 60 mm Hg if arterial blood gas sample) ; f) clinical deterioration necessitating intubation as judged by the treating clinician SECONDARY OUTCOME: Any airleak syndrome Duration of mechanical ventilation Number of surfactant treatments administered Physiological stability as determined by respiratory rate, pulse rate, mean blood pressure, FiO2, and blood pH Safety of the nebulisation procedure will be assessed by recording of apnea events and need for nasal suction occurring during the nebulisation period and comparing those to the background rate of apnea in the control group. ; We will also record any significant clinical event during nebulisation requiring medical intervention. ; ; Safety of the procedure will be further assessed by development of airleak syndromes, and frequency of apnea and/or bradycardia in the first 72 hours INCLUSION CRITERIA: Preterm infants with a gestational age (GA) between 29 w 0 d and 33 w 6 d AND late preterm and term infants with a GA between 34 w 0 d and 39 w 6 d with clinical or radiological signs of RDS requiring FiO2 of 0.22‐ 0.30 to maintain a peripheral haemoxyglobin saturation of 88‐94%.
Epistemonikos ID: ea2f424dcd0b6fde0d99975f3670c69ec1b96058
First added on: Aug 22, 2024