N/A
Completed N=21
Early CPAP And Large Volume Minimally Invasive Surfactant (ECALMIST) in Preterm Infants With RDS
Source: ClinicalTrials.gov NCT01553292 ↗Enrolled (actual)
21
Serious AEs
14.3%
Results posted
Jul 2013
Primary outcomePrimary: Incidence of Early Ventilation Hours — 4 Number of participants
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.
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 | — |
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. Informational only — not medical advice.