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Environmental or Nasal Cannula Oxygen for Preterm Infants Receiving Oxygen Therapy: a Randomized Cross-over Pilot Study
NCT02794662 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to determine if, in preterm infants \< 37 weeks' gestation at birth receiving oxygen without ventilatory/CPAP support, oxygen environment (OE) compared with nasal cannula oxygen (NC), will decrease the number of episodes with oxygen saturations less than 85% of ≥10 seconds in a 48 hour cross over period on either intervention. This is a randomized cross-over pilot study with a 1:1 parallel allocation of infants to oxygen environment or nasal cannula oxygen using stratified permuted block design. Following a 24 hour period on the first intervention, infants will cross over to a 24 hour period on the second (alternative) intervention before crossing back to the first intervention for a further 24 hours and then back again to the second (alternative) intervention for a further 24 hours.
Conditions Studied
Interventions
- PROCEDURE Oxygen Environment
- PROCEDURE Nasal Cannula Oxygen
Study Locations (1)
Alabama
- University of Alabama at Birmingham — Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2016-04 |
| Est. Completion | 2016-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02794662
The ClinicalTrials.gov registry entry for NCT02794662 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,315 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Hypoxia appearing as the primary indexed condition, and to 2 interventions — of which Oxygen Environment is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02794662 reports 1 study location spanning 1 distinct geographic area — top geographies include Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02794662 about?
NCT02794662 is a clinical study titled "Environmental or Nasal Cannula Oxygen for Preterm Infants Receiving Oxygen Therapy: a Randomized Cross-over Pilot Study". The purpose of this study is to determine if, in preterm infants \< 37 weeks' gestation at birth receiving oxygen without ventilatory/CPAP support, oxygen environment (OE) compared with nasal cannula oxygen (NC), will decrease the number of episodes with oxygen saturations less than 85% of ≥10 secon...
What is the current status of trial NCT02794662?
This trial is currently completed. It is a NA study. The enrollment target is 25 participants. The study started on 2016-04. Estimated completion is 2016-09.
What conditions does trial NCT02794662 study?
This clinical trial studies the following conditions: Hypoxia, Infant, Newborn, Diseases. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02794662?
The interventions under investigation include: Oxygen Environment (PROCEDURE), Nasal Cannula Oxygen (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02794662?
This trial is sponsored by University of Alabama at Birmingham, which has 1,315 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02794662 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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