Feasibility Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-13

Study Completion Date

2019-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Respiratory Distress Syndrome in Premature Infant Surfactant Deficiency Syndrome Neonatal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Premature babies with Respiratory Distress Syndrome and the medical need for surfactant administration (defined as FiO2 ≥ 0.3 or mod. Silverman Andersen Respiratory Severity Score ≥ 5) while treated with CPAP-support and in a gestational age \>26+0 weeks.

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Intervention Group

Surfactant administration will be done via videolaryngoscopy and the application aid Neofact in neonates with respiratory distress syndrome and airway support with CPAP. Alveofact is used as Surfactant in its standard dosage of 100 mg / kg

Group Type EXPERIMENTAL

Neofact application aid

Intervention Type DEVICE

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).

Interventions

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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).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Preterm infants with respiratory distress syndrome and the need for Surfactant administration (oxygen requirement with FiO2 ≥ 30% and/or mod. Silverman Andersen Respiratory Severity Score (RSS) ≥ 5)
* Respiratory support with non-invasive CPAP at the time of Surfactant administration

Exclusion Criteria

* Preterms with an gestational age \< 26+0 weeks
* Preterms with malformations of the respiratory tract
* Clinical decision on intubation / surfactant application via endotracheal tube e.g. because of respiratory drive disorder
* (Missing parental consent)
* (Attending physician is not delegated by the principal investigator)

Maximum Eligible Age

2 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No