Conditions: Respiratory Distress Syndrome
Keywords: laryngeal mask airway surfactant respiratory distress syndrome neonate
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 103
Healthy volunteers: no

Brief summary:
The primary objective of this research is to compare the need for intubation and mechanical ventilation in the first seven days of life for infants with respiratory distress syndrome (RDS) on nasal continuous positive airway pressure (nCPAP) who receive surfactant via a Laryngeal Mask Airway (LMA) with those who are maintained on nCPAP and do not receive surfactant.

Detailed description:
Secondary outcomes were total number of hours on mechanical ventilation, CPAP and supplemental oxygen during the first 7 days of life and for the entire hospitalization. Other secondary outcomes were number of surfactant doses, incidence of pulmonary air leak, survival until discharge, chronic lung disease (defined as need for oxygen at 36 weeks PMA), oxygen requirement at discharge, severe intraventricular hemorrhage (Grade 3/4), and periventricular leukomalacia.

Arms:
arm 1: Infants in the Control Group were maintained continuously on nasal CPAP 6 cm H2O with no surfactant administered. arm 2: Once proper placement of the LMA was achieved, surfactant (Curosurf®, 2.5 ml/kg, Chiesi USA, Inc., Cary, NC) was administered. The LMA cuff was then deflated, LMA removed and the infant placed back on nasal CPAP 6 cm H2O.

Interventions: intervention 1: Nasal continuous positive airway pressure (nCPAP) intervention 2: Laryngeal Mask Airway (LMA) to deliver surfactant intervention 3: Surfactants, Pulmonary
Intervention descriptions: intervention 1: nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU. intervention 2: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA) intervention 3: Curosurf®, Chiesi USA, Inc., Cary, NC

Protocol document: