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Use of Blended Oxygen for Delivery Room Resuscitation of Very Low Birth Weight Infants

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ClinicalTrials.gov Identifier: NCT00369720
Recruitment Status : Unknown
Verified April 2007 by University of California, San Diego.
Recruitment status was:  Active, not recruiting
First Posted : August 29, 2006
Last Update Posted : April 19, 2007
Sponsor:
Information provided by:
University of California, San Diego

Brief Summary:

We propose a preliminary trial to evaluate the safety and efficacy of using more restricted oxygen during resuscitation for VLBW infants than is utilized currently in an effort to reduce the oxidant stress of such treatment, and to possibly reduce associated multi-system organ related dysfunction.

In attempting to design a trial comparing higher versus lower oxygen during neonatal resuscitation with the potential for benefit to the enrolled infants, and a minimal level of risk, and acknowledging that the use of Room Air may be considered premature in view of the lack of any safety data in this population, we are proposing to utilize an oxygen blender and a pulse oximeter in the delivery room in the treated group. The treated group will have their fraction of inspired oxygen increased from 21%, as necessary, to achieve a target oxygen saturation of 85 to 90% at 5 minutes of life, compared with the standard of care group who will receive 100% oxygen without the use of a blender, which is the current approach in most centers in this country. The targeted saturation of 85% will provide enough oxygen to treat any ventilation/perfusion mismatch, while exposing the infants to significantly less inspired oxygen.

Hypothesis: We hypothesize that the use of restricted inspired oxygen during resuscitation will result in a significant reduction in oxidant stress without any harmful clinical effects.


Condition or disease Intervention/treatment Phase
Prematurity Oxidant Injury Procedure: Titration of oxygen in delivery room Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Blended Oxygen for Delivery Room Resuscitation of VLBW Infants
Study Start Date : January 2005
Estimated Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy




Primary Outcome Measures :
  1. total antioxidant status
  2. lipid peroxide levels
  3. oxygen saturations

Secondary Outcome Measures :
  1. Days on oxygen
  2. Days on conventional ventilation
  3. Days on high frequency ventilation
  4. Days on nasal canula
  5. Pneumothorax
  6. Oxygen requirement at 36 weeks adjusted age
  7. Patent ductus arteriosus
  8. Patent ductus arteriosus requiring ligation
  9. Necrotizing Enterocolitis
  10. Surgery for necrotizing enterocolitis
  11. Isolated gastrointestinal perforation
  12. Intracranial hemorrhage
  13. Periventricular leukomalacia
  14. Retinopathy
  15. Death


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Ages Eligible for Study:   23 Weeks to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • inborn infant
  • gestation 23 weeks to 31 weeks 6 days

Exclusion Criteria:

  • known chromosomal or congenital anomalies

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 ClinicalTrials.gov identifier (NCT number): NCT00369720


Locations
United States, California
University of California San Diego Medical Center
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Neil N Finer, MD University of California, San Diego

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00369720     History of Changes
Other Study ID Numbers: 051169
First Posted: August 29, 2006    Key Record Dates
Last Update Posted: April 19, 2007
Last Verified: April 2007

Keywords provided by University of California, San Diego:
Prematurity
Resuscitation
Room Air

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications