Feasibility Study - Neofact

NCT04086095 | Completed

• 1 other identifier: feasibility study - Neofact
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Respiratory Distress Syndrome in Premature Infant; Surfactant Deficiency Syndrome Neonatal

Keywords

Respiratory Distress Syndrome; Less Invasive Surfactant Administration; Neofact; Preterm babies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Duration of the surfactant administration procedure

  up to 20 minutes

• Duration of the laryngoscopy

  up to 15 minutes

• Need for intubation and mechanical ventilation

  48 hours after administration

• Number of attempts needed for the correct application

  during application procedure

• Occurrence of complications

  during application procedure

Study Arms (1)

Intervention Group

EXPERIMENTAL

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

Interventions

Neofact application aid DEVICE

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).

Intervention Group

Eligibility Criteria

• Age: Up to 2 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• Klinikum Stuttgart: collaborator

Study Sites (2)

Klinikum Stuttgart - Olgahospital

Stuttgart, Baden-Wurttemberg, 70176, Germany

Location

University Hospital

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Related Publications (6)

• 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.

  PMID: 10224173 BACKGROUND

• 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.

  PMID: 15173537 BACKGROUND

• 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.

  PMID: 18272893 BACKGROUND

• 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.

  PMID: 27842300 BACKGROUND

• 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.

  PMID: 25389349 BACKGROUND

• 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.

  PMID: 32429874 DERIVED

MeSH Terms

Conditions

Pulmonary Atelectasis; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Christian A. Maiwald, Dr.

  Department of Neonatology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: September 11, 2019
• Study Start: May 13, 2019
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: November 5, 2019

Record last verified: 2019-08

Locations

DE (2)