An interventional study of Targeting SpO2 at 93-95% and Targeting SpO2 at 90-92% in Apnea of Prematurity, Desaturation of Blood and Central Apnea, sponsored by University of Miami. Completed at 1 site in United States. Open to participants aged Up to 18 Weeks. Per ClinicalTrials.gov, last updated 2023-05-10.
Sponsored by University of Miami · Not applicable, Interventional, and Other
This is a prospective crossover study to compare the within-subject effect of the two target ranges of arterial oxygen saturation (SpO2), both within the clinically recommended range of 90- 95%. The specific objective of this study to evaluate the impact of targeting SpO2 within 93-95% compared to the 90-92% range on ventilatory stability in premature infants of 23-29 weeks gestational age (GA).
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 19 is below the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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%
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%
FiO2 adjusted to keep basal SpO2 at target range of 93-95% for 2 hours
FiO2 adjusted to keep basal SpO2 at target range of 90-92% for 2 hours.
ventilatory stability by frequency of central apnea
by frequency of central apnea
Time frame: 2 hours
ventilatory stability by frequency of obstructive apnea
by frequency of obstructive apnea
Time frame: 2 hours
ventilatory stability by density of periodic breathing
by density of periodic breathing
Time frame: 2 hours
ventilatory stability by time series of inter-breath intervals
by time series of inter-breath intervals
Time frame: 2 hours
oxygenation stability by frequency of intermittent hypoxemia episodes
frequency of episodes with SpO2 \< 80%
Time frame: 2 hours
frequency of bradycardia episodes
frequency of episodes with HR \< 100 bpm
Time frame: 2 hours
Plan to share: No
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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University of Miami