N/A
N=21
Early CPAP And Large Volume Minimally Invasive Surfactant (ECALMIST) in Preterm Infants With RDS
Respiratory Distress Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01553292 ↗Enrolled (actual)
21
Serious AEs
14.3%
Results posted
Jul 2013
Primary outcome: Primary: Incidence of Early Ventilation Hours — 4 Number of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ECALMIST (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of Manitoba
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Early Ventilation Hours |
4 | — |
| SECONDARY Incidence of Bradycardia During Procedure |
3 | — |
| SECONDARY Saturation During the Procedure |
0.87 | — |
| SECONDARY Failure to Catheterized the Trachea by the Vascular Catheter |
1 | — |
| SECONDARY Index Before the Procedure |
2.61 | — |
| SECONDARY CPAP Pressure After the Procedure |
5.8 | — |
| SECONDARY Oxygen Requirement Before the Procedure |
0.308 | — |
| SECONDARY Oxygen Saturation After the Procedure |
0.94 | — |
| SECONDARY Index After the Procedure |
1.27 | — |
| SECONDARY CPAP Pressure Before the Proceudre |
7.1 | — |
| SECONDARY Oxygen Saturation Before the Procedure |
0.87 | — |
| SECONDARY Oxygen Requirements After the Procedure |
0.257 | — |
| SECONDARY Needs for Intubation During the Procedure |
3 | — |
Summary
Modification of Minimally Invasive Surfactant Therapy (MIST) to a new technique called ECALMIST (Early CPAP And Large volume Minimal Invasive Surfactant). This modification is needed to adapt the use of large volume surfactant of 4-5 ml/kg.
The ECALMIST will be used to deliver the large volume Surfactant that been used in Canada called BLES (about 5 ml for each 100 mg) to the preterm infants bellow 35 weeks gestation suffer from respiratory distress syndrome (RDS) in 1st 24 hours of life while maintained on CPAP.
Eligibility Criteria
Inclusion Criteria
-preterm infants less than 35 weeks gestation in 1st day of life with RDS and spontaneously breathing on CPAP and need surfactant administration.
Exclusion Criteria
- Infants needs of mechanical ventilation
- Congenital anomaly
- Respiratory distress due to non RDS related causes.
- no parental consent
Data sourced from ClinicalTrials.gov (NCT01553292). 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.