Method of Oxygen Delivery and the Effect on Transcutaneous PaCO2

NCT00135252 | Terminated Phase 2

• 1 other identifier: Nasal cannula
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Diseases, Obstructive

Keywords

developing chronic lung disease

Outcome Measures

Primary Outcomes (1)

• Change in transcutaneous PaCO2

Secondary Outcomes (1)

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

Interventions

nasal cannula oxygen delivery PROCEDURE

supplemental oxygen delivery by hood PROCEDURE

Eligibility Criteria

• Age: 1 Week - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

Memorial Hermann Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Lung Diseases, Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Kathleen A Kennedy, MD, MPH

  University of Texas at Houston Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 23, 2005
• First Posted: August 25, 2005
• Study Start: August 1, 2005
• Study Completion: June 1, 2006
• Last Updated: January 8, 2008

Record last verified: 2007-12

Locations

US (1)