Clinical trial NCT05399914: Feasibility and Reliability of Synchronized Non-invasive Intermittent Positive Pressure Ventilation in Preterm Infants After Birth
Official title: Feasibility and Reliability of Synchronized Non-invasive Intermittent Positive Pressure Ventilation in Preterm Infants After Birth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Infant
Delivery Room
Respiratory Support
Synchronized Noninvasive Positive Pressure Ventilation (SNIPPV)
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm infants born at University Hospital in Tübingen.

Brief summary: The aim of this prospective observational study (pilot study) is to test if synchronized noninvasive positive pressure ventilation (S-NIPPV) is feasible and works appropriately during transition from intrauterine to extrauterine life in very preterm infants in the delivery room.

Detailed description: The study period will be the first 10 minutes after birth.

All patients will be non-invasively ventilated using an EVE NEO ventilator (CE 0482, Fritz Stephan GmbH, Gackenbach, Germany). A facemask will be used throughout the study period. Synchronization will be achieved using graseby capsule (Stephan, Vio Healthcare), which will be secured at the abdominal wall on the midaxillary line below the ribs. For the detection of spontaneous breaths respiratory induction plethysmography (RIP) is used. For this purpose, an extra small plethysmography belt (Sleepsense, Elgin, USA) is placed around the abdomen. The data of the plethysmography belts are processed and stored with the NewLifebox-XL (Advanced Life Diagnostics UG, Weener, Germany) and merged with the data from the ventilator for later evaluation.

Infants according to the clinician's assessment only needing CPAP will receive S-NIPPV with very low PIP levels. This enables to have enough ventilator breaths applied for analysis to obtain sufficient data about the synchronization rate of S-NIPPV in the delivery room and meanwhile consider the infant's safety by not applying high pressures where it might not be needed. The ventilator support settings will be PIP 10, PEEP 6 in the noninvasive pressure controlled assist control ventilation (nPC-ACV+) mode. In this mode every spontaneous breath is supported by a ventilator breath (if the triggering level is exceeded). The triggering level will be set at 0,5 to avoid autotriggering and unsupported breaths. The inspiratory time will be set at max. 0,3 sec. The backup ventilation rate is set at 60 per minute.The EVE NEO ventilator has in the nPC-ACV+ mode an option where the ventilator breaths are interrupted/stopped as soon as the graseby capsule detects a start of spontaneous expiration.

If the infant according to the clinician's assessment needs S-NIPPV (e.g. the infant is apnoeic, and/or heart rate is below 100 bpm), the pressure of S-NIPPV will be augmented to target PIP 20, PEEP 6 (unless clinical concerns require an adjustment). The respiratory support can be deescalated to PIP 10 once the clinician deems the higher pressure no longer necessary.

The following demographical characteristics will be collected from the patient charts (pseudonymized): gender, gestational age, birth weight, antenatal steroids, mode of delivery, reason for prematurity (prolong premature rupture of membrane, infection, pathologic CTG, pathological doppler, gestosis), time of cord clamping, umbilical cord pH, FiO2 requirement, APGAR.

The following interventions within the first 10 minutes after birth including the time will be noted: tactile stimulation, placement of an intravenous line, non-invasive surfactant administration, intubation, chest compression, administration of volume, catecholamine, blood or other medication.

Eligibility criteria: Inclusion Criteria:

* Preterm infants with a gestational age (GA) between 26 ≥ and \< 32 weeks

Exclusion Criteria:

* Major congenital malformations
* Refused parental consent (prenatal parental consent is necessary)

Primary outcomes:
measure: Synchronisation rate
timeFrame: First 10 minutes after birth
Secondary outcomes:
measure: False negative rate
timeFrame: First 10 minutes after birth
measure: False positive rate
timeFrame: First 10 minutes after birth
measure: Proportion of artifacts
timeFrame: First 10 minutes after birth
measure: Specificity (true negative rate)
timeFrame: First 10 minutes after birth
measure: Proportion of back up breaths
timeFrame: First 10 minutes after birth
measure: Proportion of time of synchronised breaths, non-synchronized breaths, periods of apnoea and periods of movement artefacts occure within the first ten minutes of respiratory support.
timeFrame: First 10 minutes after birth
measure: Time until the graseby capsule is attached to the infant's abdomen and the proportion of infants in whom the graseby capsule is attached within the first two minutes after birth.
timeFrame: First 10 minutes after birth
measure: Proportion of time non invasive ventilator breaths will be applied.
timeFrame: First 10 minutes after birth
measure: Peak inspiratory pressure (PIP)
timeFrame: First 10 minutes after birth
measure: Positive end expiatory pressure (PEEP)
timeFrame: First 10 minutes after birth
measure: Mean airway pressure (MAP)
timeFrame: First 10 minutes after birth
measure: Td (time delay) graseby
timeFrame: First 10 minutes after birth
measure: Td (time delay) ventilator
timeFrame: First 10 minutes after birth
measure: Ti ventilator
timeFrame: First 10 minutes after birth
measure: Ti RIP
timeFrame: First 10 minutes after birth
measure: Ti excess
timeFrame: First 10 minutes after birth
measure: Swing RIP
timeFrame: First 10 minutes after birth
measure: Number of tactile stimulations and other interventions on the patient
timeFrame: First 10 minutes after birth
measure: Heart rate
timeFrame: First 10 minutes after birth
measure: Oxygen saturation
timeFrame: First 10 minutes after birth
measure: Fraction of inspired oxygen
timeFrame: First 10 minutes after birth
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Hospital Tuebingen
state: Baden-Wuerttemberg
Study officials:
References: