N/A
N=103
Laryngeal Mask Airway (LMA) for Surfactant Administration in Neonates
Respiratory Distress Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01116921 ↗Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcome: Primary: Need for Intubation and Mechanical Ventilation in the First Seven Days of Life. — 34; 19 Participants — p=0.006
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nasal continuous positive airway pressure (nCPAP) (Device); Laryngeal Mask Airway (LMA) to deliver surfactant (Device); Surfactants, Pulmonary (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Need for Intubation and Mechanical Ventilation in the First Seven Days of Life. |
34; 19 | 0.006 sig |
| SECONDARY Duration of CPAP Therapy |
50; 56 | — |
| SECONDARY Duration of Oxygen Therapy |
55; 56 | — |
| SECONDARY Incidence of Pulmonary Airleaks |
5; 4 | — |
| SECONDARY Incidence of Severe IVH or PVL |
0; 0 | — |
| SECONDARY Incidence of Chronic Lung Disease |
0; 2 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01116921). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.