This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2007 by University of California, San Diego.
Recruitment status was:  Active, not recruiting
Information provided by:
University of California, San Diego Identifier:
First received: August 28, 2006
Last updated: April 18, 2007
Last verified: April 2007

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
Intervention Model: Parallel Assignment
Masking: None (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


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

Inclusion Criteria:

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

Exclusion Criteria:

  • known chromosomal or congenital anomalies
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00369720

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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00369720     History of Changes
Other Study ID Numbers: 051169
Study First Received: August 28, 2006
Last Updated: April 18, 2007

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

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications processed this record on September 20, 2017