Arterial Oxygen Saturation on Ventilatory Stability in Ex... | NCT03695900 | Trialant

Arterial Oxygen Saturation on Ventilatory Stability in Ex... | NCT03695900 | Trialant

Sponsor/Collaborators Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Targeting SpO2 at 93-95% followed by targeting at 90-92%	Other	FiO2 adjusted to keep basal SpO2 at target range of 93-95% for 2 hours, followed by FiO2 adjusted to keep basal SpO2 at target range of 90-92% for 2 hours.	Other: Targeting SpO2 at 93-95% Other: Targeting SpO2 at 90-92%
Targeting SpO2 at 90-92% followed by targeting at 93-95%	Other	FiO2 adjusted to keep basal SpO2 at target range of 90-92% for 2 hours, followed by FiO2 adjusted to keep basal SpO2 at target range of 93-95% for 2 hours.	Other: Targeting SpO2 at 93-95% Other: Targeting SpO2 at 90-92%

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Targeting SpO2 at 93-95%	Other	FiO2 adjusted to keep basal SpO2 at target range of 93-95% for 2 hours	Targeting SpO2 at 90-92% followed by targeting at 93-95% Targeting SpO2 at 93-95% followed by targeting at 90-92%

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ventilatory stability by frequency of central apnea	by frequency of central apnea	2 hours
ventilatory stability by frequency of obstructive apnea	by frequency of obstructive apnea	2 hours
ventilatory stability by density of periodic breathing	by density of periodic breathing	2 hours
ventilatory stability by time series of inter-breath intervals	by time series of inter-breath intervals	2 hours

Secondary Outcomes

Measure	Description	Time Frame
oxygenation stability by frequency of intermittent hypoxemia episodes	frequency of episodes with SpO2 < 80%	2 hours
frequency of bradycardia episodes	frequency of episodes with HR < 100 bpm

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
Nelson Claure, MSc, PhD	University of Miami	Principal Investigator
Eduardo Bancalari, MD	University of Miami	Principal Investigator
Deepak Jain, MD	University of Miami	Principal Investigator
Waleed Kurtom, MD	Jackson Health System	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36030769	Derived	Kurtom W, Dormishian A, Jain D, Schott A, Aguilar AC, Grieb G, Bancalari E, Claure N. Effect of the Target Range on Arterial Oxygen Saturation Stability in Extremely Premature Infants. Neonatology. 2022;119(5):638-643. doi: 10.1159/000525271. Epub 2022 Aug 26.

Condition Browse Module