Method of Oxygen Delivery and the Effect on Transcutaneous PaCO2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00135252
Recruitment Status : Terminated (Investigator left institution)
First Posted : August 25, 2005
Last Update Posted : January 8, 2008
Information provided by:
The University of Texas Health Science Center, Houston

Brief 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.

Condition or disease Intervention/treatment Phase
Lung Diseases, Obstructive Procedure: nasal cannula oxygen delivery Procedure: supplemental oxygen delivery by hood Phase 2 Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Method of Oxygen Delivery (Comparison Nasal Cannula vs Oxygen Hood) and the Effect on Transcutaneous PaCO2
Study Start Date : August 2005
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Change in transcutaneous PaCO2

Secondary Outcome Measures :
  1. Heart rate, respiratory rate, apnea, escalation in respiratory care (CPAP, mechanical ventilation, methylxanthines, diuretics, steroids), proven sepsis

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00135252

United States, Texas
Memorial Hermann Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Principal Investigator: Kathleen A Kennedy, MD, MPH University of Texas at Houston Medical School Identifier: NCT00135252     History of Changes
Other Study ID Numbers: Nasal cannula
First Posted: August 25, 2005    Key Record Dates
Last Update Posted: January 8, 2008
Last Verified: December 2007

Keywords provided by The University of Texas Health Science Center, Houston:
developing chronic lung disease

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases