Laryngeal Mask Airway (LMA) for Surfactant Administration in Neonates

University of Minnesota (UMN)

Status: Completed

Conditions: Respiratory Distress Syndrome

Treatments: Drug: Surfactants, Pulmonary; Device: Nasal continuous positive airway pressure (nCPAP); Device: Laryngeal Mask Airway (LMA) to deliver surfactant

Study type: Interventional

Funder types: Other

Identifiers

NCT01116921

1004M81177

Details and patient eligibility

About

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.

Full 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.

Enrollment: 103 patients

Sex: All

Ages: Under 36 hours old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Gestational age at time of enrollment 28 0/7 to 35 6/7 weeks postmenstrual age
• Age less than or equal to 36 hours old
• On nCPAP 6 with supplemental oxygen requirement (Fi02 greater than or equal to 30%) for greater than or equal to 30 minutes (to maintain Sa02 between 88-92%)
• Chest radiograph and clinical presentation consistent with respiratory distress syndrome (tachypnea, retractions, nasal flaring, and/or grunting

Exclusion criteria

• Prior mechanical ventilation or surfactant administration
• Major congenital anomaly
• Abnormality of the airway
• Respiratory distress secondary to an etiology other than respiratory distress syndrome (pneumothorax, meconium aspiration syndrome, pneumonia, hypoxic-ischemic encephalopathy)
• Apgar score < 5 at 5 minutes of age

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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103 participants in 2 patient groups

nCPAP Control Group

Active Comparator group

Description:

Infants in the Control Group were maintained continuously on nasal CPAP 6 cm H2O with no surfactant administered.

Treatment:

Device: Nasal continuous positive airway pressure (nCPAP)

LMA Group

Experimental group

Description:

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.

Treatment:

Drug: Surfactants, Pulmonary

Device: Laryngeal Mask Airway (LMA) to deliver surfactant

Device: Nasal continuous positive airway pressure (nCPAP)