No registrations found.
ID
Source
Health condition
Prematurity. BPD.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Saturations within target range (88-95%)
Hyperoxia (saturations >95%)
Hypoxia (saturations <88%)
Severe hypoxia (saturations <80%)
Secondary outcome
Manual interventions on FiO2
Bradycardia (number)
Mean FiO2
Background summary
In order to avoid hypo- and hyperoxia in preterm infants, oxygen administration is manually controlled by the nurses with use of pulseoximetry. However, with manual control of oxygen administration, oxygen saturations are still 50 time percent above or below the target range. New ventilators are able to automatically adjust oxygen administration guided by pulseoxymetry. Different studies in preterm infants on mechanical ventilation or Continuous Positive Airway Pressure (CPAP), have shown that the use of ventilators with closed loop oxygen administration leads to a significant higher amount of saturations within target range. However, recent ventilators combine the closed-loop technology with High Flow Nasal Cannula (HFNC) support, which resembles CPAP. We aim to study the effect of closed loop oxygenation in preterm infants on HFNC on amount of time spent within saturation target range.
Study objective
The use of automated closed loop oxygen control in infants on infants with high flow nasal canulla (HFNC) support, will lead to higher amount of saturations within target range compared to manual control.
Study design
After birth (Gestational Age<30 weeks) and with FiO2 >0.25, during NICU admission. After parental consent.
Intervention
In this observational cross-over study we mark two consecutive periods of 24 hours each, in whom oxygen delivery to infant will be controlled by the certified PRICO device or manually by the nurse. The sequence of oxygen control (i.e. manual-FiO2 first or PRICO first) will be determined by randomization, using sequentially numbered opaque sealed envelopes.
H. Niemarkt
Veldhoven 5500 MB
The Netherlands
+31 (0)40 8889350
H.Niemarkt@mmc.nl
H. Niemarkt
Veldhoven 5500 MB
The Netherlands
+31 (0)40 8889350
H.Niemarkt@mmc.nl
Inclusion criteria
• Preterm infants born with Gestational Age < 30 weeks.
• On HFNC support according to standard of care protocol see table 1.
• Supplemental oxygen need
• Witten parental consent
Exclusion criteria
• Major congenital abnormalities
• Hemodynamic instability
• Culture proven sepsis <72 h for enrolment
• Post-hoc: change in respiratory support mode (i.e. Intubation, CPAP)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL7375 |
NTR-old | NTR7583 |
Other | METC Veldhoven : N 17.007 |