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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23497

Enrollment

Registered

2018-10-02

Start date

2017-01-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prematurity. BPD.

Interventions

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. Th

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
Saturations within target range (88-95%) Hyperoxia (saturations >95%) Hypoxia (saturations <88%) Severe hypoxia (saturations <80%)	—

Secondary

Measure	Time frame
Manual interventions on FiO2 Bradycardia (number) Mean FiO2	—

Contacts

Public ContactH. Niemarkt

Máxima Medical Centre Veldhoven, P.O. Box 7777

H.Niemarkt@mmc.nl+31 (0)40 8889350

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)