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 range

18 Weeks

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Plain-language summary

Who can participate

Age range

18 Weeks

Sex

ALL

See this in plain English?

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