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Feasibility Study - Neofact

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04086095
Recruitment Status : Recruiting
First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Klinikum Stuttgart
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome in Premature Infant Surfactant Deficiency Syndrome Neonatal Device: Neofact application aid Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Device 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.
Actual Study Start Date : May 13, 2019
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : October 31, 2019

Arm Intervention/treatment
Experimental: 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
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).

Primary Outcome Measures :
  1. feasibility of the application aid Neofact [ Time Frame: 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 :
  1. Duration of the surfactant administration procedure [ Time Frame: 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).

  2. Duration of the laryngoscopy [ Time Frame: 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).

  3. Need for intubation and mechanical ventilation [ Time Frame: 48 hours after administration ]
    Number of neonates that need intubation and mechanical ventilation in the observational period of 48 hours after surfactant administration

  4. Number of attempts needed for the correct application [ Time Frame: during application procedure ]
    to evaluate how good the handling of the application aid will be

  5. Occurrence of complications [ Time Frame: 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

  6. Colonization of the catheter tip [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04086095

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Contact: Christian A. Maiwald, Dr. 0049 7071 29 ext 81418

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Klinikum Stuttgart - Olgahospital Recruiting
Stuttgart, Baden-Wuerttemberg, Germany, 70176
Contact: Christian A. Maiwald, Dr.    0049 7071 29 ext 81418   
Principal Investigator: Patrick Neuberger, Dr.         
University Hospital Recruiting
Tuebingen, Baden-Wuerttemberg, Germany, 72076
Contact: Christian A. Maiwald, Dr.    0049 7071 29 ext 81418   
Principal Investigator: Axel R. Franz, Prof. Dr.         
Sponsors and Collaborators
University Hospital Tuebingen
Klinikum Stuttgart
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Study Chair: Christian A. Maiwald, Dr. Department of Neonatology

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Responsible Party: University Hospital Tuebingen Identifier: NCT04086095     History of Changes
Other Study ID Numbers: feasibility study - Neofact
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Tuebingen:
Respiratory Distress Syndrome
Less Invasive Surfactant Administration
Preterm babies
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Tract Diseases
Infant, Newborn, Diseases
Premature Birth
Pathologic Processes
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Lung Diseases
Respiration Disorders
Infant, Premature, Diseases
Pulmonary Surfactants
Respiratory System Agents