Method of Oxygen Delivery and the Effect on Transcutaneous PaCO2
Stopped early · Phase 2/Phase 3
Conditions studied: Lung Diseases, Obstructive
In brief
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.
Key facts
- Study ID
- NCT00135252
- Run by
- The University of Texas Health Science Center, Houston
- People needed
- 44
- Starts
- 2005-08-01
- Expected to finish
- 2006-06-01
- Last updated by the study team
- 2008-01-08
Who can join
Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Infants with an oxygen requirement (FiO2 of > 0.3 to maintain pulse oxygen saturations 85-95%)
- On the ventilator or nasal continuous positive airway pressure (NCPAP) for > 1 week ready to be changed to nasal cannula
- Weight less than 2500 grams and < 1500 grams birth weight
You may not qualify if…
- Obvious chromosomal or congenital anomaly for craniofacial or respiratory system anomalies
- Known significant congenital heart disease (excluding patent ductus arteriosus)
- Seizures or known neuromuscular disease
- Received steroids in week prior to eligibility
Where it is running
- Memorial Hermann Children's Hospital — Houston, Texas, United States
Full record on ClinicalTrials.gov
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