Feasibility Study - Neofact

University Hospital Tuebingen

Status: Completed

Conditions: Respiratory Distress Syndrome in Premature Infant; Surfactant Deficiency Syndrome Neonatal

Treatments: Device: Neofact application aid

Study type: Interventional

Funder types: Other

Identifiers

NCT04086095

feasibility study - Neofact

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: Under 2 days old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Intervention Group

Experimental group

Description:

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

Treatment:

Device: Neofact application aid