Laryngeal Mask Airway (LMA) for Surfactant Administration in Neonates

Study Overview
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Brief Summary
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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
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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.

Official Title
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Laryngeal Mask Airway (LMA) for Surfactant Administration in Neonates

Conditions
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Respiratory Distress Syndrome

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 36 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: nCPAP Control Group<br>Infants in the Control Group were maintained continuously on nasal CPAP 6 cm H2O with no surfactant administered. | Device: Nasal continuous positive airway pressure (nCPAP)<br>* nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.<br>|
| Experimental: LMA Group<br>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. | Device: Nasal continuous positive airway pressure (nCPAP)<br>* nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.<br>Device: Laryngeal Mask Airway (LMA) to deliver surfactant<br>* Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)<br>Drug: Surfactants, Pulmonary<br>* Curosurf®, Chiesi USA, Inc., Cary, NC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for Intubation and Mechanical Ventilation in the First Seven Days of Life. | 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. | Seven days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of CPAP Therapy |  | During first seven days of life | 
| Duration of Oxygen Therapy |  | During first seven days of life | 
| Incidence of Pulmonary Airleaks |  | First 7 days of life | 
| Incidence of Severe IVH or PVL |  | During hospitalization | 
| Incidence of Chronic Lung Disease |  | Measured at hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laryngeal mask airway, surfactant, respiratory distress syndrome, neonate