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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: Clinical Trial Phase 2 study, sponsored by The University of Texas Health Science Center, Houston.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
Why NCT00135252 stopped before completion
NCT00135252 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which nasal cannula oxygen delivery is the first listed.
NCT00135252 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00135252's enrollment target sits among peer trials
44 1322nd of 2000 higher than 669 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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