Feasibility Study - Neofact

Study Overview
=================
Brief 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.

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.

Conditions
-----------------
Respiratory Distress Syndrome in Premature Infant, Surfactant Deficiency Syndrome Neonatal

Intervention / Treatment
-----------------
* Device: Neofact application aid


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Maximum Age: 2 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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 | Device: Neofact application aid<br>* 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feasibility of the application aid Neofact | Feasibility will be defined as a correct intratracheal position of the catheter (visually controlled via videolaryngoscope) OR responsiveness of the child to the surfactant administration (defined as decrease of the fraction of inspired oxygen (FiO2) of at least 0.05 within 30 minutes after the application OR FiO2 decrease to 0.21 with simultaneous improvement of the modified Silverman Andersen Respiratory Severity Score (RSS) ≥ 2 within 30 minutes after the application) without switching to a conventional LISA method RSS in the modified version of McAdams RM et al. The RSS consists of 5 categories that assess the respiratory work of the child in a range from 0 to 2 in each category. This results in a summarized score of 0 to 10, in which 0 defines a healthy neonate without increased work of breathing and 10 a neonate with maximum respiratory distress. | Administration of surfactant + 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of the surfactant administration procedure | Measured time from the beginning of the initial insertion of the laryngoscope (plate tip passes the lips) to the removal of the application aid Neofact (Neofact tip passes the lips). | up to 20 minutes | 
| Duration of the laryngoscopy | Measured time from the beginning of the initial insertion of the laryngoscope (plate tip passes the lips) to the removal of the laryngoscope (plate tip passes the lips). | up to 15 minutes | 
| Need for intubation and mechanical ventilation | Number of neonates that need intubation and mechanical ventilation in the observational period of 48 hours after surfactant administration | 48 hours after administration | 
| Number of attempts needed for the correct application | to evaluate how good the handling of the application aid will be | during application procedure | 
| Occurrence of complications | Number of decreases of oxygen saturation (< 80% SpO2), bradycardia (< 80 / min), tachycardia (> 200 / min), arterial hypo- (middle arterial blood pressure < Gestational Age (GA)) or hypertension (middle arterial blood pressure > GA + 20), onset and / or severity of coughing, choking, apnea & laryngospasm during the procedure | during application procedure | 
| Colonization of the catheter tip | Name of germs and their number of colony forming units (CFU) placed on the catheter tip. To evaluate if there is a risk of contamination | up to 20 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Respiratory Distress Syndrome, Less Invasive Surfactant Administration, Neofact, Preterm babies