Laryngeal Mask Airway (LMA) for Surfactant Administration in Neonates

Not Applicable

Completed

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

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
nCPAP Control Group	Nasal continuous positive airway pressure (nCPAP)	Infants in the Control Group were maintained continuously on nasal CPAP 6 cm H2O with no surfactant administered.
LMA Group	Nasal continuous positive airway pressure (nCPAP)	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.
LMA Group	Laryngeal Mask Airway (LMA) to deliver surfactant	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.
LMA Group	Surfactants, Pulmonary	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.

Primary Outcome Measures

Name	Time	Method
Need for Intubation and Mechanical Ventilation in the First Seven Days of Life.	Seven days	"Treatment Failure" criteria were the same for both groups. "Treatment Failure" required two of the following: 1) FiO2 \>40% for longer than 30 minutes (to maintain SaO2 88-92%), 2) PCO2 \>65mmHg on ABG/CBG or \>70 on VBG, or 3) pH\<7.22 on ABG/CBG/VBG or one of the following: 1) recurrent or severe apnea, 2) hemodynamic instability requiring pressors, 3) repeat surfactant dose at appropriate time with FiO2 \>40%, or 4) deemed necessary by medical provider.

Secondary Outcome Measures

Name	Time	Method
Duration of CPAP Therapy	During first seven days of life
Incidence of Severe IVH or PVL	During hospitalization
Duration of Oxygen Therapy	During first seven days of life
Incidence of Pulmonary Airleaks	First 7 days of life
Incidence of Chronic Lung Disease	Measured at hospital discharge

Locations (7): Loma Linda University Medical Center
🇺🇸
Loma Linda, California, United States
Maple Grove Hospital
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Maple Grove, Minnesota, United States
University of Minnesota Children's Hospital
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Minneapolis, Minnesota, United States
North Memorial Hospital
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Robbinsdale, Minnesota, United States
St Paul Children's Hospital
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St Paul, Minnesota, United States
University of Wisconsin- Madison
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Madison, Wisconsin, United States
University of California- San Diego Medical Center
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San Diego, California, United States