Respiratory Distress Syndrome in Premature Infant, Surfactant Deficiency Syndrome Neonatal
Conditions
Keywords
Respiratory Distress Syndrome, Less Invasive Surfactant Administration, Neofact, Preterm babies
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.
Interventions
DEVICENeofact 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).
Sponsors
Klinikum Stuttgart
University Hospital Tuebingen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
No minimum to 2 Days
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| feasibility of the application aid Neofact | 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
| Measure | Time frame | Description |
|---|---|---|
| Duration of the laryngoscopy | 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 | 48 hours after administration | Number of neonates that need intubation and mechanical ventilation in the observational period of 48 hours after surfactant administration |
| Duration of the surfactant administration procedure | 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). |
| Occurrence of complications | 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 | 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 |
| Number of attempts needed for the correct application | during application procedure | to evaluate how good the handling of the application aid will be |
Countries
Germany
Outcome results
None listed