Respiratory Distress Syndrome, Newborn Clinical Trial
Official title:
LISA Catheter With Marked vs. Unmarked Tip in Extremely Low Birth Weight Infants With RDS: a Crossover Randomized Controlled Manikin Trial
This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA catheter with a marked tip vs. LISA catheter with an unmarked tip in a manikin simulating an extremely low birth weight infant. Participants will be level III NICU consultants and residents. Randomization will be performed using a computer-generated random assignment list. The primary outcome measure will be the positioning of the device at the correct depth in the trachea. The secondary outcome measures will be the time and number of attempts to achieve the correct depth and participant satisfaction.
Although less invasive surfactant administration (LISA) offers some advantages in ventilation procedure and neonatal outcomes, achieving the correct depth in the trachea using a LISA catheter may be difficult. This may have some drawbacks such as impaired surfactant administration (reducing the efficacy of the procedure) or prolonged duration of the laryngoscopy (aggravating the invasiveness of the procedure). The aims of the present study should be: i) positioning of the device at the correct depth in the trachea, ii) time and number of attempts to achieve the correct depth, iii) participant satisfaction. This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA catheter with a marked tip vs. LISA catheter with an unmarked tip in a manikin simulating an extremely low birth weight infant. Participants will be level III NICU consultants and residents. Randomization will be performed using a computer-generated random assignment list. The primary outcome measure will be the positioning of the device at the correct depth in the trachea. The secondary outcome measures will be the time and number of attempts to achieve the correct depth and participant satisfaction. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT01206946 -
Efficacy of Antenatal Steroids in Reducing Respiratory Morbidities in Late Preterm Infants
|
Phase 2 | |
| Completed |
NCT00739115 -
The Use of Heliox Via Nasal CPAP to Prevent Early CPAP Failure in Premature Infants: A Feasibility Study
|
N/A | |
| Terminated |
NCT00486395 -
Will CPAP Reduce Length Of Respiratory Support In Premature Infants?
|
Phase 3 | |
| Completed |
NCT01242462 -
Feasibility of Mid-frequency Ventilation in Newborns With RDS: Randomized Crossover Pilot Trial
|
Phase 1/Phase 2 | |
| Enrolling by invitation |
NCT02050971 -
Autologous Cord Blood Infusion for the Prevention and Treatment of Prematurity Complications In Preterm Neonates
|
Phase 1 | |
| Completed |
NCT00486850 -
Synchronized Intermittent Mandatory Ventilation (SIMV) Versus Nasal Intermittent Positive Pressure Ventilation (NIPPV) In Preterm Infants With Respiratory Distress
|
Phase 4 | |
| Terminated |
NCT00005776 -
Inhaled Nitric Oxide Study for Respiratory Failure in Newborns
|
Phase 3 | |
| Completed |
NCT04500353 -
Routine Or Selective Application of a Face Mask for Preterm Infants at Birth: the ROSA Trial
|
N/A | |
| Completed |
NCT05796128 -
NIPPV vs.nCPAP During LISA Procedure
|
N/A | |
| Withdrawn |
NCT02835209 -
Positioning During SBT in NICU Infants
|
N/A | |
| Terminated |
NCT01467076 -
Inhaled Prostaglandin E1 (IPGE1) for Hypoxemic Respiratory Failure (NHRF)
|
Phase 2 | |
| Completed |
NCT00828243 -
Genetic Regulation of Surfactant Deficiency
|
||
| Completed |
NCT00556738 -
Intrapulmonary Percussive Ventilation (IPV) Versus Nasal Continuous Positive Airway Pressure Ventilation (nCPAP) in Transient Respiratory Distress of the Newborn
|
N/A | |
| Not yet recruiting |
NCT05594030 -
Thoracic Fluid Content by Electric Bioimpedance Versus Lung Ultrasound in Preterm Neonates With Respiratory Distress
|
||
| Completed |
NCT02332304 -
Amniotic Fluid Optical Density Determination as a Test for Assessment of Fetal Lung Maturity.
|
Phase 3 | |
| Withdrawn |
NCT00598429 -
Inhaled PGE1 in Neonatal Hypoxemic Respiratory Failure
|
Phase 2 | |
| Completed |
NCT04137783 -
ABCA3 Gene and RDS in Late Preterm and Term Infants
|
||
| Completed |
NCT01941524 -
Brain Oxygenation and Function of Preterm Newborns During Administration of Two Different Surfactant Preparations
|
Phase 4 | |
| Completed |
NCT01102543 -
Observational Study on the Prophylactic Use of Curosurf in Neonatal Respiratory Distress Syndrome (RDS)
|
N/A | |
| Completed |
NCT00501982 -
Efficacy of Combining Prophylactic Curosurf With Early Nasal CPAP in Delivery Room: the Curpap Study
|
Phase 4 |