Clinical trial NCT04086095: Feasibility Study - Neofact
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome in Premature Infant
Surfactant Deficiency Syndrome Neonatal
Keywords: Respiratory Distress Syndrome
Less Invasive Surfactant Administration
Neofact
Preterm babies
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: Klinikum Stuttgart
First posted: 2019-09-11
Enrollment: 20
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: DEVICE_FEASIBILITY

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.


Eligibility criteria: 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)

Primary outcomes:
measure: feasibility of the application aid Neofact
timeFrame: Administration of surfactant + 30 minutes
Secondary outcomes:
measure: Duration of the surfactant administration procedure
timeFrame: up to 20 minutes
measure: Duration of the laryngoscopy
timeFrame: up to 15 minutes
measure: Need for intubation and mechanical ventilation
timeFrame: 48 hours after administration
measure: Number of attempts needed for the correct application
timeFrame: during application procedure
measure: Occurrence of complications
timeFrame: during application procedure
measure: Colonization of the catheter tip
timeFrame: up to 20 minutes
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: Klinikum Stuttgart - Olgahospital
state: Baden-Wuerttemberg
city: Tuebingen
country: Germany
facility: University Hospital
state: Baden-Wuerttemberg
Study officials:
affiliation: Department of Neonatology
name: Christian A. Maiwald, Dr.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.