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Feasibility Study - Neofact

Respiratory Distress Syndrome in Premature Infant Clinical Trial

Official title:
Feasibility Study - Neofact Feasibility Study of the Application Aid Neofact (Formerly: QuickSF) in the Less Invasive Surfactant Administration (LISA) in Premature Infants With Respiratory Distress Syndrome.

Clinical Trial Summary

For therapy of respiratory distress syndrome (RDS) in premature babies, there are several established options. An important therapeutic aspect is the tracheal administration of exogenous surfactant into the child's lung.

In the recent years, several methods have been developed. The methods differ in the selected ventilation mode (intubation with mechanical ventilation vs. Continous Positive Airway Pressure (CPAP)-supported spontaneous breathing) and in the way in which the application of surfactant is technically conducted (via endotracheal tube, endotracheal catheter or nebulization).

In selection of ventilation technique, there is an upcoming trend towards less invasive respiratory support via CPAP. While this may increase the rate of complications on the one side (i.e. pneumothorax), it shows much lower oxygen demand and a shorter need for mechanical ventilation on the other side.

In the selection of the administration technique, different methods were repeatedly developed to adapt the surfactant administration to the CPAP therapy. In this study, a newly developed and in the European Community now certified (CE-Mark) application aid (Neofact) will be tested for the first time on preterm infants, to verify the feasibility.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Premature Birth
  • Respiratory Distress Syndrome in Premature Infant
  • Respiratory Distress Syndrome, Adult
  • Respiratory Distress Syndrome, Newborn
  • Surfactant Deficiency Syndrome Neonatal
  • Syndrome
Clinical Trial Details
NCT number NCT04086095
Study type Interventional
Source University Hospital Tuebingen
Contact
Status Completed
Phase N/A
Start date May 13, 2019
Completion date October 31, 2019
View Details
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