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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by University of California, San Diego.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00369720
First received: August 28, 2006
Last updated: April 18, 2007
Last verified: April 2007
  Purpose

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 Intervention
Prematurity
Oxidant Injury
Procedure: Titration of oxygen in delivery room

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Blended Oxygen for Delivery Room Resuscitation of VLBW Infants

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • total antioxidant status
  • lipid peroxide levels
  • oxygen saturations

Secondary Outcome Measures:
  • Days on oxygen
  • Days on conventional ventilation
  • Days on high frequency ventilation
  • Days on nasal canula
  • Pneumothorax
  • Oxygen requirement at 36 weeks adjusted age
  • Patent ductus arteriosus
  • Patent ductus arteriosus requiring ligation
  • Necrotizing Enterocolitis
  • Surgery for necrotizing enterocolitis
  • Isolated gastrointestinal perforation
  • Intracranial hemorrhage
  • Periventricular leukomalacia
  • Retinopathy
  • Death

Estimated Enrollment: 40
Study Start Date: January 2005
Estimated Study Completion Date: January 2008
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   23 Weeks to 32 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • known chromosomal or congenital anomalies
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by University of California, San Diego

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00369720     History of Changes
Other Study ID Numbers: 051169
Study First Received: August 28, 2006
Last Updated: April 18, 2007
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on July 23, 2014