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Implementation of Predictive Intelligent Control of Oxygenation (PRICO®) on High Flow Nasal Cannula Support in preterm infants.


- candidate number29628
- NTR NumberNTR7583
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-okt-2018
- Secondary IDsN 17.007 METC Veldhoven
- Public TitleImplementation of Predictive Intelligent Control of Oxygenation (PRICO®) on High Flow Nasal Cannula Support in preterm infants.
- Scientific TitleImplementation of Predictive Intelligent Control of Oxygenation (PRICO®) on High Flow Nasal Cannula Support in preterm infants.
- ACRONYM
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedPrematurity, Bronchopulmonary dysplasia
- 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)
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jan-2017
- planned closingdate1-jan-2019
- Target number of participants25
- InterventionsIn 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.
- Primary outcomeSaturations within target range (88-95%)
Hyperoxia (saturations >95%)
Hypoxia (saturations <88%)
Severe hypoxia (saturations <80%)
- Secondary outcomeManual interventions on FiO2
Bradycardia (number)
Mean FiO2
- TimepointsAfter birth (Gestational Age<30 weeks) and with FiO2 >0.25, during NICU admission. After parental consent.
- Trial web sitenone
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. H. Niemarkt
- CONTACT for SCIENTIFIC QUERIESMD. H. Niemarkt
- Sponsor/Initiator Maxima Medical Center, Veldhoven
- Funding
(Source(s) of Monetary or Material Support)
Chiesi Pharmaceuticals
- Publications
- Brief summaryIn 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.
- Main changes (audit trail)
- RECORD2-okt-2018 - 7-nov-2018


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