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

NCT00369720 | Completed

• 1 other identifier: 051169
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Prematurity; Oxidant Injury

Keywords

Prematurity; Resuscitation; Room Air

Outcome Measures

Primary Outcomes (3)

• total antioxidant status

• lipid peroxide levels

• oxygen saturations

Secondary Outcomes (15)

• Days on oxygen

• Days on conventional ventilation

• Days on high frequency ventilation

• Days on nasal canula

• Pneumothorax

Interventions

Titration of oxygen in delivery room PROCEDURE

Eligibility Criteria

• Age: 23 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• known chromosomal or congenital anomalies

Sponsors & Collaborators

• Neil Finer: lead

Study Sites (1)

University of California San Diego Medical Center

San Diego, California, 92103, United States

Location

Related Publications (1)

• Wang CL, Anderson C, Leone TA, Rich W, Govindaswami B, Finer NN. Resuscitation of preterm neonates by using room air or 100% oxygen. Pediatrics. 2008 Jun;121(6):1083-9. doi: 10.1542/peds.2007-1460.

  PMID: 18519476 DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Delivery Rooms

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hospital Units; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Neil N Finer, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 28, 2006
• First Posted: August 29, 2006
• Study Start: January 1, 2005
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: October 4, 2019

Record last verified: 2019-10

Locations

US (1)