An observational study in Preterm Infant, Delivery Room and Respiratory Support, sponsored by University Hospital Tuebingen. Completed at 1 site in Germany. Per ClinicalTrials.gov, last updated 2024-09-23.
Sponsored by University Hospital Tuebingen · Observational
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.
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.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's enrollment of 10 is below the median of 112 across 777 observational studies indexed under Premature Birth.
Browse Premature Birth studies →University Hospital Tuebingen is the lead sponsor of 476 studies on the registry; 104 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Preterm infants born at University Hospital in Tübingen.
Exclusion Criteria:
Other: S-NIPPV
Synchronized noninvasive positive pressure ventilation during the first 10 minutes after birth.
Synchronisation rate
Synchronisation rate (sensitivity/true positive rate) of S-NIPPV in the delivery room meaning the proportion of graseby triggered synchronized ventilator breaths with corresponding RIP signal related to all spontaneous breaths detected by RIP.
Time frame: First 10 minutes after birth
False negative rate
Proportion of non-synchronized ventilator breaths with corresponding RIP signal. This will be related to all spontaneous breaths detected by RIP.
Time frame: First 10 minutes after birth
False positive rate
Proportion of graseby triggered ventilator breaths without corresponding RIP signal. This will be related to all ventilator breaths without a corresponding RIP signal (i.e. movement artefacts).
Time frame: First 10 minutes after birth
Proportion of artifacts
Proportion of graseby triggered ventilator breaths without corresponding RIP signal. This will be related to all ventilator breaths.
Time frame: First 10 minutes after birth
Specificity (true negative rate)
Proportion of ventilator breaths without corresponding RIP signal and with no graseby signal (i.e. during an apnoea). This will be related to all ventilator breaths without a corresponding RIP signal.
Time frame: First 10 minutes after birth
Proportion of back up breaths
Proportion of ventilator breaths without corresponding RIP signal and with no graseby signal. This will be related to all ventilator breaths.
Time frame: First 10 minutes after birth
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.
Time frame: First 10 minutes after birth
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.
Time frame: First 10 minutes after birth
Proportion of time non invasive ventilator breaths will be applied.
Time frame: First 10 minutes after birth
Peak inspiratory pressure (PIP)
Time frame: First 10 minutes after birth
Positive end expiatory pressure (PEEP)
Time frame: First 10 minutes after birth
Mean airway pressure (MAP)
Time frame: First 10 minutes after birth
Td (time delay) graseby
Time between the initial increase of the abdominal RIP curve and the initial increase of the graseby curve.
Time frame: First 10 minutes after birth
Td (time delay) ventilator
Time between the initial increase of the graseby curve and the beginning of the pressure curve.
Time frame: First 10 minutes after birth
Ti ventilator
Inspiratory time of a ventilator breath
Time frame: First 10 minutes after birth
Ti RIP
Inspiratory time of a spontaneous breath
Time frame: First 10 minutes after birth
Ti excess
Calculated: ((Ti ventilator - Ti RIP)/Ti RIP)) x 100
Time frame: First 10 minutes after birth
Swing RIP
Amplitude of the RIP curve calculated by subtracting the baseline RIP from the peak RIP curve, which is a surrogate parameter for the patient's respiratory effort.
Time frame: First 10 minutes after birth
Number of tactile stimulations and other interventions on the patient
Number of tactile stimulations and other interventions on the patient (e.g. placement of intravenous line, non-invasive administration of surfactant, intubation, chest compression) are documented by video analysis.
Time frame: First 10 minutes after birth
Heart rate
Time frame: First 10 minutes after birth
Oxygen saturation
Time frame: First 10 minutes after birth
Fraction of inspired oxygen
Time frame: First 10 minutes after birth
Plan to share: Undecided
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University Hospital Tuebingen