Feasibility Study – Neofact

Overview

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.

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Device Feasibility
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 31, 2019

Interventions

  • 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).

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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).
  • 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).
  • 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
  • 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
  • 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
  • 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

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 2 Days

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital Tuebingen
  • Collaborator
    • Klinikum Stuttgart
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Christian A. Maiwald, Dr., Study Chair, Department of Neonatology

References

Lindner W, Vossbeck S, Hummler H, Pohlandt F. Delivery room management of extremely low birth weight infants: spontaneous breathing or intubation? Pediatrics. 1999 May;103(5 Pt 1):961-7.

Dani C, Bertini G, Pezzati M, Cecchi A, Caviglioli C, Rubaltelli FF. Early extubation and nasal continuous positive airway pressure after surfactant treatment for respiratory distress syndrome among preterm infants <30 weeks' gestation. Pediatrics. 2004 Jun;113(6):e560-3.

Morley CJ, Davis PG, Doyle LW, Brion LP, Hascoet JM, Carlin JB; COIN Trial Investigators. Nasal CPAP or intubation at birth for very preterm infants. N Engl J Med. 2008 Feb 14;358(7):700-8. doi: 10.1056/NEJMoa072788. Erratum in: N Engl J Med. 2008 Apr 3;358(14):1529.

Maiwald CA, Neuberger P, Vochem M, Poets C. QuickSF: A New Technique in Surfactant Administration. Neonatology. 2017;111(3):211-213. doi: 10.1159/000450823. Epub 2016 Nov 15.

McAdams RM, Hedstrom AB, DiBlasi RM, Mant JE, Nyonyintono J, Otai CD, Lester DA, Batra M. Implementation of Bubble CPAP in a Rural Ugandan Neonatal ICU. Respir Care. 2015 Mar;60(3):437-45. doi: 10.4187/respcare.03438. Epub 2014 Nov 11.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.