Feasibility Study - Neofact

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.

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.

Study Overview

• Status: Completed
• Conditions: Surfactant Deficiency Syndrome Neonatal; Respiratory Distress Syndrome in Premature Infant
• Intervention / Treatment: Device: Neofact application aid

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Baden-Wuerttemberg
    • Stuttgart, Baden-Wuerttemberg, Germany, 70176
      • Klinikum Stuttgart - Olgahospital
    • Tuebingen, Baden-Wuerttemberg, Germany, 72076
      • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 days (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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).

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

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Collaborators: Klinikum Stuttgart
• Investigators: Study Chair: Christian A. Maiwald, Dr., Department of Neonatology

Publications and helpful links

General Publications

• 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. doi: 10.1542/peds.103.5.961.
• 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. doi: 10.1542/peds.113.6.e560.
• 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.
• Maiwald CA, Dick J, Marschal M, Gille C, Franz AR, Poets CF. Microbiological analyses of nasally guided catheters after less invasive surfactant administration - a pilot study. BMC Pediatr. 2020 May 19;20(1):234. doi: 10.1186/s12887-020-02147-0.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 13, 2019
• Primary Completion (ACTUAL): October 31, 2019
• Study Completion (ACTUAL): October 31, 2019

Study Registration Dates

• First Submitted: September 3, 2019
• First Submitted That Met QC Criteria: September 9, 2019
• First Posted (ACTUAL): September 11, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 5, 2019
• Last Update Submitted That Met QC Criteria: November 4, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Respiratory Distress Syndrome; Less Invasive Surfactant Administration; Neofact; Preterm babies
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Infant, Premature, Diseases; Syndrome; Premature Birth; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: feasibility study - Neofact

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No