Feasibility Study - Neofact

Not Applicable

Completed

• Conditions: Surfactant Deficiency Syndrome Neonatal; Respiratory Distress Syndrome in Premature Infant
• Interventions: Device: Neofact application aid

• Registration Number: NCT04086095
• Lead Sponsor: University Hospital Tuebingen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-13
• Status Verified: 2019-08
• Study First Submitted: 2019-09-03
• Study First Submitted QC: 2019-09-09
• Study First Posted: 2019-09-11
• Primary Completion: 2019-10-31
• Study Completion: 2019-10-31
• Last Update Submitted: 2019-11-04
• Last Update Posted: 2019-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Group	Neofact application aid	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

Primary Outcome Measures

Name	Time	Method
feasibility of the application aid Neofact	Administration of surfactant + 30 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Number of attempts needed for the correct application	during application procedure	to evaluate how good the handling of the application aid will be
Duration of the surfactant administration procedure	up to 20 minutes	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).
Need for intubation and mechanical ventilation	48 hours after administration	Number of neonates that need intubation and mechanical ventilation in the observational period of 48 hours after surfactant administration
Occurrence of complications	during application procedure	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
Duration of the laryngoscopy	up to 15 minutes	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).
Colonization of the catheter tip	up to 20 minutes	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

Trial Locations

Locations (2)

Klinikum Stuttgart - Olgahospital; 🇩🇪 Stuttgart, Baden-Wuerttemberg, Germany

University Hospital; 🇩🇪 Tuebingen, Baden-Wuerttemberg, Germany