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NCT00135252 · ClinicalTrials.gov registry record · Phase 2
Method of Oxygen Delivery and the Effect on Transcutaneous PaCO2
A Phase 2 study, sponsored by The University of Texas Health Science Center, Houston.
- Terminated
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
NCT00135252 is a Phase 2 study that was terminated before completion, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 44 participants.
The verdict
NCT00135252, a Phase 2 study, was terminated before completion, sponsored by The University of Texas Health Science Center, Houston.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
Study Summary
Infants of \< 1500 grams of birth weight who require a \> 1 week mechanical ventilation (breathing machine) or CPAP \[continuous positive airway pressure\] (oxygen at a high flow through the nose) may have prolonged oxygen requirements. The nasal cannula (oxygen through the nose at a low flow) is the most commonly used method of oxygen administration, despite a lack of data regarding its safety and efficacy. Low birth weight infants are vulnerable to obstruction from secretions and blood, as well as the presence of the nasal cannula. Partially obstructed nostrils greatly increase the work of breathing. Additional potential adverse effects include an increased need for suctioning, increased risk for systemic infection, and inadvertent positive end expiratory pressure (CPAP). No study has been conducted to evaluate the efficacy of the nasal cannula compared to an oxygen hood (plastic "hood" that is placed over the infant's head to provide oxygen) on gas exchange or infection. Among infants who require supplemental oxygen (by either a nasal cannula or an oxygen hood) for clinical indications, objectives the investigators hope to accomplish in a randomized blinded (investigator) trial: Aim 1: To determine the short-term effect of different flows of oxygen by the nasal cannula on transcutaneous PCO2 (PTCO2). Aim 2: To determine, once optimal flow is established in Aim 1, the effect of prolonged (one week) use of a nasal cannula compared to an oxygen hood on PTCO2.
Interventions
- PROCEDURE nasal cannula oxygen delivery
- PROCEDURE supplemental oxygen delivery by hood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2005-08 |
| Est. Completion | 2006-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00135252
The ClinicalTrials.gov registry entry for NCT00135252 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center, Houston, which has 732 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which nasal cannula oxygen delivery is the first listed.
NCT00135252 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00135252 about?
NCT00135252 is a clinical study titled "Method of Oxygen Delivery and the Effect on Transcutaneous PaCO2". Infants of \< 1500 grams of birth weight who require a \> 1 week mechanical ventilation (breathing machine) or CPAP \[continuous positive airway pressure\] (oxygen at a high flow through the nose) may have prolonged oxygen requirements. The nasal cannula (oxygen through the nose at a low flow) is th...
What is the current status of trial NCT00135252?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2005-08. Estimated completion is 2006-06.
What interventions are being tested in trial NCT00135252?
The interventions under investigation include: nasal cannula oxygen delivery (PROCEDURE), supplemental oxygen delivery by hood (PROCEDURE).
Who is sponsoring clinical trial NCT00135252?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
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