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Feasibility Study - Neofact

NCT04086095 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-11-05

No results posted yet for this study

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.

Conditions

  • Respiratory Distress Syndrome in Premature Infant
  • Surfactant Deficiency Syndrome Neonatal

Interventions

DEVICE

Neofact application aid

The Neofact application aid is a specifically for the LISA procedure designed guide of a soft catheter and replaces the Magill forceps. Catheter (3.5 Fr.) and guide are already combined and packed together sterile. The catheter tip is marked in black (1cm).

Sponsors & Collaborators

  • Klinikum Stuttgart

    collaborator OTHER

  • University Hospital Tuebingen

    lead OTHER

Principal Investigators

  • Christian A. Maiwald, Dr. · Department of Neonatology

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
2 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-13
Primary Completion
2019-10-31
Completion
2019-10-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04086095 on ClinicalTrials.gov