ABSTRACT
OBJECTIVE: To determine if preterm infants with moderate respiratory distress syndrome on continuous positive airway pressure (CPAP) who received surfactant via a laryngeal mask airway (LMA) would have a decreased rate of intubation and mechanical ventilation compared with those on CPAP who did not receive surfactant. STUDY DESIGN: In this prospective, multicenter, randomized controlled trial, 103 premature infants 280/7-356/7 weeks gestation, ≥1250 g and ≤36 hours old on CPAP requiring fraction of inspired oxygen 0.30-0.40 were assigned to receive surfactant administered through an LMA then placed back on CPAP (LMA group) or maintained on CPAP with no surfactant administered (control group). The primary outcome was treatment failure necessitating intubation and mechanical ventilation in the first 7 days of life. RESULTS: Surfactant administration through an LMA (n = 50) significantly decreased the rate of intubation and mechanical ventilation compared with controls (n = 53): 38% vs 64%, respectively, OR 0.30 (95% CI 0.13, 0.70), P = .006, number needed to treat: 4). There were no serious adverse events associated with placement of the LMA or surfactant administration. CONCLUSIONS: In premature neonates with moderate respiratory distress syndrome, surfactant administered through an LMA decreased the rate of intubation and mechanical ventilation. This intervention may have significant impact on clinical care in both high and low resource settings. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01116921.
Subject(s)
Continuous Positive Airway Pressure/methods , Laryngeal Masks , Pulmonary Surfactants/administration & dosage , Respiratory Distress Syndrome, Newborn/therapy , Continuous Positive Airway Pressure/adverse effects , Continuous Positive Airway Pressure/statistics & numerical data , Female , Humans , Infant, Newborn , Infant, Premature , Intubation, Intratracheal/statistics & numerical data , Male , Prospective Studies , Treatment Failure , Treatment OutcomeABSTRACT
Gastroesophageal reflux (GER) is common in preterm infants and usually is a physiologic phenomenon with little clinical consequence. GER resulting in clinical signs and symptoms is considered pathologic gastroesophageal reflux disease (GERD). Correlation of clinical signs and symptoms with GER has been poor in most studies. The efficacy of GERD therapy has not been studied systematically in preterm infants. Furthermore, GERD therapy, particularly with prokinetic agents and surgery, carries potential risks that must be considered before initiation of therapy. Alternative diagnoses, pretreatment diagnostic testing, and desired treatment outcomes should be considered before initiating GERD therapy. Cessation of empiric GERD therapy should be considered, particularly if treatment does not result in the desired clinical outcome.
