CompletedNot Applicable

Arterial Oxygen Saturation on Ventilatory Stability in Extremely Premature Infants

United States19 participantsStarted 2018-11-01

Plain-language summary

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).

Who can participate

Age range18 Weeks

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 23 0/7- 29 6/7 weeks gestational age * Postnatal age ≥ 14 days * Requiring FiO2 ≥ 0.25 to keep SpO2 90-95% * Parental informed consent Exclusion Criteria: * Severe congenital anomalies that may affect pulmonary or neurosensory development * Severe CNS pathology that may alter respiratory control function

What they're measuring

ventilatory stability by frequency of central apnea

Timeframe: 2 hours

ventilatory stability by frequency of obstructive apnea

Timeframe: 2 hours

ventilatory stability by density of periodic breathing

Timeframe: 2 hours

ventilatory stability by time series of inter-breath intervals

Timeframe: 2 hours

Trial details

NCT IDNCT03695900

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-11-08

View on ClinicalTrials.gov More Apnea of Prematurity trials