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NCT02794662 · ClinicalTrials.gov registry record · NA

Environmental or Nasal Cannula Oxygen for Preterm Infants Receiving Oxygen Therapy: a Randomized Cross-over Pilot Study

A NA study of Hypoxia and Infant, Newborn, Diseases, sponsored by University of Alabama at Birmingham.

Completed
Registry status
NA
Development phase
25
Enrollment target
1
Study location

NCT02794662 is a NA study of Hypoxia and Infant, Newborn, Diseases that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 25 participants, below the 3,116-participant average among 39 other Hypoxia trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02794662, a NA study of Hypoxia and Infant, Newborn, Diseases, has completed, sponsored by University of Alabama at Birmingham.

COMPLETED
Registry status
NA
Development phase
25 participants
Enrollment target
1
Study location

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.

Interventions

  • PROCEDURE Oxygen Environment
  • PROCEDURE Nasal Cannula Oxygen

Study Locations (1)

Alabama

  • University of Alabama at Birmingham - Birmingham

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2016-04
Est. Completion 2016-09
Phase NA

Sponsor

University of Alabama at Birmingham

1,160 total trials

What the Registry Record Tells You About NCT02794662

The ClinicalTrials.gov registry entry for NCT02794662 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,116-participant average among 39 other Hypoxia trials with a reported enrollment target (99% lower). The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.

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.

NCT02794662 reports 1 study location spanning 1 distinct geographic area - top geographies include Alabama.

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.

What interventions are being tested in trial NCT02794662?

The interventions under investigation include: Oxygen Environment (PROCEDURE), Nasal Cannula Oxygen (PROCEDURE).

Who is sponsoring clinical trial NCT02794662?

This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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