Method of Oxygen Delivery and the Effect on Transcutaneous PaCO2

This study has been terminated.
(Investigator left institution)
Sponsor:
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00135252
First received: August 23, 2005
Last updated: December 23, 2007
Last verified: December 2007
  Purpose

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 Intervention Phase
Lung Diseases, Obstructive
Procedure: nasal cannula oxygen delivery
Procedure: supplemental oxygen delivery by hood
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Method of Oxygen Delivery (Comparison Nasal Cannula vs Oxygen Hood) and the Effect on Transcutaneous PaCO2

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Change in transcutaneous PaCO2

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

Estimated Enrollment: 44
Study Start Date: August 2005
Study Completion Date: June 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00135252

Locations
United States, Texas
Memorial Hermann Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Kathleen A Kennedy, MD, MPH University of Texas at Houston Medical School
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00135252     History of Changes
Other Study ID Numbers: Nasal cannula
Study First Received: August 23, 2005
Last Updated: December 23, 2007
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 16, 2014