Laryngeal Mask Airway (LMA) for Surfactant Administration in Neonates
This study is currently recruiting participants.
Verified April 2013 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01116921
First received: May 3, 2010
Last updated: April 25, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Respiratory Distress Syndrome |
Device: Nasal continuous positive airway pressure (nCPAP) Device: Laryngeal Mask Airway (LMA) to deliver surfactant |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Laryngeal Mask Airway (LMA) for Surfactant Administration in Neonates |
Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:
Primary Outcome Measures:
- Need for intubation and mechanical ventilation in the first seven days of life. [ Time Frame: Seven days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Duration of CPAP therapy [ Time Frame: During hospitalization ] [ Designated as safety issue: No ]
- Duration of oxygen therapy [ Time Frame: During hospitalization ] [ Designated as safety issue: No ]
- Incidence of pulmonary airleaks [ Time Frame: First 7 days of life ] [ Designated as safety issue: No ]
- Incidence of severe IVH or PVL [ Time Frame: During hospitalization ] [ Designated as safety issue: No ]
- Incidence of Chronic Lung Disease [ Time Frame: Measured at hospital discharge ] [ Designated as safety issue: No ]
- Time, number of attempts, and physiologic stability [ Time Frame: During LMA or ETT placement ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 144 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | May 2015 |
| Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: nCPAP Control Group |
Device: Nasal continuous positive airway pressure (nCPAP)
nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
|
| Experimental: LMA Group |
Device: Nasal continuous positive airway pressure (nCPAP)
nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
Device: Laryngeal Mask Airway (LMA) to deliver surfactant
Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)
|
Eligibility| Ages Eligible for Study: | up to 36 Hours |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01116921
Contacts
| Contact: Kari D Roberts, M.D. | 612-625-9577 | rober694@umn.edu |
Locations
| United States, California | |
| Loma Linda University Medical Center | Recruiting |
| Loma Linda, California, United States, 92350 | |
| Contact: Allen Merritt, M.D. 909-558-7448 | |
| Principal Investigator: Allen Merritt, M.D. | |
| University of California- San Diego Medical Center | Recruiting |
| San Diego, California, United States, 92103 | |
| Contact: Sijani Tipnis, M.D. 619-471-0209 | |
| Principal Investigator: Sijani Tipnis, M.D. | |
| Sub-Investigator: Wade Rich, BSHS, RRT, CCRC | |
| United States, Minnesota | |
| University of Minnesota Amplatz Children's Hospital | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Kari D Roberts, M.D. 612-625-9577 rober694@umn.edu | |
| Principal Investigator: Kari D Roberts, M.D. | |
| St Paul Children's Hospital | Recruiting |
| St Paul, Minnesota, United States, 55102 | |
| Contact: Andrea L Lampland, M.D. 651-220-5736 | |
| Principal Investigator: Andrea L Lampland, M.D. | |
| Sub-Investigator: Mark C Mammel, M.D. | |
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
| Study Chair: | Kari D Roberts, M.D. | University of Minnesota Amplatz Children's Hospital |
| Principal Investigator: | Sijani Tipnis, M.D. | University of California, San Diego |
| Principal Investigator: | Andrea L Lampland, M.D. | St Paul Children's Hospital |
| Principal Investigator: | Allen Merritt, M.D. | Loma Linda University |
More Information
No publications provided
| Responsible Party: | University of Minnesota - Clinical and Translational Science Institute |
| ClinicalTrials.gov Identifier: | NCT01116921 History of Changes |
| Other Study ID Numbers: | 1004M81177 |
| Study First Received: | May 3, 2010 |
| Last Updated: | April 25, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
|
neonatal respiratory distress syndrome surfactant laryngeal mask airway |
Additional relevant MeSH terms:
|
Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Lung Diseases Respiratory Tract Diseases Respiration Disorders Infant, Premature, Diseases |
Infant, Newborn, Diseases Pulmonary Surfactants Respiratory System Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013