Feasibility Study - Neofact

Respiratory Distress Syndrome in Premature Infant Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04086095
• Other study ID #: feasibility study - Neofact
• Status: Completed
• Phase: N/A
• Start date: May 13, 2019
• Est. completion date: October 31, 2019

Study information

• Verified date: August 2019
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Days

Eligibility

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)

Related Conditions & MeSH terms

• Premature Birth
• Respiratory Distress Syndrome in Premature Infant
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Surfactant Deficiency Syndrome Neonatal
• Syndrome

Intervention

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).

Locations

Country	Name	City	State
Germany	Klinikum Stuttgart - Olgahospital	Stuttgart	Baden-Wuerttemberg
Germany	University Hospital	Tuebingen	Baden-Wuerttemberg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Tuebingen	Klinikum Stuttgart

Country where clinical trial is conducted

Germany, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. Erratum in: N Engl J Med. 2008 Apr 3;358(14):1529. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Number of attempts needed for the correct application	to evaluate how good the handling of the application aid will be	during application procedure
Secondary	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
Secondary	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