Clinical trial NCT01553292: Early CPAP And Large Volume Minimally Invasive Surfactant (ECALMIST) in Preterm Infants With RDS
Official title: Feasibility of Using Early CPAP (Continuous Positive Airway Pressure) And Large Volume Minimal Invasive Surfactant Therapy (ECALMIST) in Preterm Infants With Respiratory Distress Syndrome (RDS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome
Keywords: Respiratory distress syndrome
Preterm infants
Vascular catheter
Surfactant
CPAP
ECALMIST
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2012-03-14
Enrollment: 21
Sex: ALL
Minimum age (years): 10
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: The 5 ml/Kg surfactant is warm to room temperature. Using standard laryngoscope without premedication while the infant is maintained on continuous positive airway pressure (CPAP. The the laryngoscope should be removed after stabilizing the vascular catheter between 2 fingers at the level of lips (weight +6 cm). The surfactant will be administer by boluses of 0.25 -0.5 ml at a time over 20-30 seconds and 10 seconds apart while maintain the vital signs.

The procedure should be stopped if the vital signs deteriorate, CPAP pressure and oxygen requirement might need to adjusted to restore baseline vital signs. If the vital signs remained unstable the catheter should be removed and the infant managed according by positive pressure ventilation (PPV) or intubation by endotracheal tube (ETT).

At the end of the procedure the catheter should be flushed with 0.5 ml of air then catheter should be removed.

FiO2 (fraction of inspired oxygen), oxygen saturation and CPAP pressure will be recorded before during and after the procedure.

Complication like bradycardia (Hear rate below 100 beat per minute) or Apnea (pause of respiration for more than 20 second or less than 20 seconds but associated with bradycardia) All other neonatal outcome will be recorded (IVH \[Intra-ventricular Hemorrhage\], ROP \[Retinopathy of prematurity\], duration of ventilation, duration of hospital stay, infection, duration of oxygen requirement and others.

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

Primary outcomes:
measure: Incidence of Early Ventilation Hours
timeFrame: 72 hours
Secondary outcomes:
measure: Incidence of Bradycardia During Procedure
timeFrame: Range of 10 minutes
measure: Saturation During the Procedure
timeFrame: 10 minutes
measure: Failure to Catheterized the Trachea by the Vascular Catheter
timeFrame: 20 seconds
measure: Index Before the Procedure
timeFrame: 1 hour
measure: CPAP Pressure After the Procedure
timeFrame: 4 hours
measure: Oxygen Requirement Before the Procedure
timeFrame: 1 hour
measure: Oxygen Saturation After the Procedure
timeFrame: 4 hours
measure: Index After the Procedure
timeFrame: 4 hours
measure: CPAP Pressure Before the Proceudre
timeFrame: 1 hour
measure: Oxygen Saturation Before the Procedure
timeFrame: 1 hour
measure: Oxygen Requirements After the Procedure
timeFrame: 4 hours
measure: Needs for Intubation During the Procedure
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Children hospital of health Sciences Center
state: Manitoba
city: Winnipeg
country: Canada
facility: Women's Hospital Health Science Center
state: Manitoba
city: Winnipeg
country: Canada
facility: St. Boniface Hospital
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Yahya Al Ethawi, MD
role: PRINCIPAL_INVESTIGATOR
References: