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Laryngeal Mask Airway (LMA) for Surfactant Administration in Neonates

Primary Purpose

Respiratory Distress Syndrome

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Nasal continuous positive airway pressure (nCPAP)

Laryngeal Mask Airway (LMA) to deliver surfactant

Surfactants, Pulmonary

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome focused on measuring laryngeal mask airway, surfactant, respiratory distress syndrome, neonate

Eligibility Criteria

undefined - 36 Hours (Child)All SexesDoes not accept 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

Sites / Locations

Loma Linda University Medical Center
University of California- San Diego Medical Center
Maple Grove Hospital
University of Minnesota Children's Hospital
North Memorial Hospital
St Paul Children's Hospital
University of Wisconsin- Madison

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

nCPAP Control Group

LMA Group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Duration of CPAP Therapy

Duration of Oxygen Therapy

Incidence of Pulmonary Airleaks

Incidence of Severe IVH or PVL

Incidence of Chronic Lung Disease

Full Information

NCT ID

NCT01116921

First Posted

May 3, 2010

Last Updated

January 6, 2017

Sponsor

University of Minnesota

1. Study Identification

Unique Protocol Identification Number

NCT01116921

Brief Title

Laryngeal Mask Airway (LMA) for Surfactant Administration in Neonates

Official Title

Laryngeal Mask Airway (LMA) for Surfactant Administration in Neonates

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

February 2011 (undefined)

Primary Completion Date

April 2015 (Actual)

Study Completion Date

April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Minnesota

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Distress Syndrome

Keywords

laryngeal mask airway, surfactant, respiratory distress syndrome, neonate

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

103 (Actual)

8. Arms, Groups, and Interventions

Arm Title

nCPAP Control Group

Arm Type

Active Comparator

Arm Description

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

Arm Title

LMA Group

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Nasal continuous positive airway pressure (nCPAP)

Intervention Description

nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.

Intervention Type

Device

Intervention Name(s)

Laryngeal Mask Airway (LMA) to deliver surfactant

Intervention Description

Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)

Intervention Type

Drug

Intervention Name(s)

Surfactants, Pulmonary

Intervention Description

Curosurf®, Chiesi USA, Inc., Cary, NC

Primary Outcome Measure Information:

Title

Need for Intubation and Mechanical Ventilation in the First Seven Days of Life.

Description

Time Frame

Seven days

Secondary Outcome Measure Information:

Title

Duration of CPAP Therapy

Time Frame

During first seven days of life

Title

Duration of Oxygen Therapy

Time Frame

During first seven days of life

Title

Incidence of Pulmonary Airleaks

Time Frame

First 7 days of life

Title

Incidence of Severe IVH or PVL

Time Frame

During hospitalization

Title

Incidence of Chronic Lung Disease

Time Frame

Measured at hospital discharge

10. Eligibility

Sex

All

Maximum Age & Unit of Time

36 Hours

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: