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

October 2, 2019 updated by: Neil Finer

Use of Blended Oxygen for Delivery Room Resuscitation of VLBW Infants

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We propose to study the preterm infant (gestational age 23-32 weeks) as these infants are the most vulnerable to the acute and chronic possible toxicities of excess oxygen and the associated oxygen free radicals. We will study 40 infants.

Infants will be randomized following parental consent obtained prior to delivery to initially be placed on a pulse oximeter and receive blended oxygen to a targeted oxygen saturation of 85 to 90% at 5 minutes of life, or 100% oxygen for a minimum of 5 minutes without the use of a blender. The inspired oxygen will be increased using the blender if the infant's SaO2 remains less than 60% at two minutes, less than 70% at 3 minutes, and/or if bradycardia with a heart rate of less than 100 bpm persists after 2 minutes of resuscitation.

Cord blood will be obtained following our usual procedures and a portion will be saved for later analysis of lipid peroxides, oxidized and reduced glutathione and total antioxidant status. Similar assays will be performed at 1 hour, week and at 1 month for all surviving infants.

Intervention:

Prior to the infant's delivery, the randomization will be drawn from double sealed envelopes randomized by blocks of 10. A blender will be in place in the delivery room area and provide the source of oxygen to the resuscitation device. Following randomization and before the delivery, the blender will be turned to either 21% or 100%. The respiratory therapist will increase the blender immediately to 100% oxygen under the following conditions:

  1. Need for chest compressions or medication administration
  2. Heart rate is less than 100 at 2 minutes of life
  3. Heart rate less than 60 for 30 seconds at any time of life.

Oxygen will be incrementally increased in the room air group by the following protocol:

If O2 Sat: Blender:

< 70 at 3 min, increase to 50% x30 sec No Response: increase to 75% x30 sec No Response: increase to 100%

< 85 at 5 min, increase to 50% x30 sec No Response: increase to 75% x30 sec No Response: increase to 100%

A pulse oximeter will be placed on the infant's extremity, preferably the right hand. The data stored in the oximeter will be retrieved and the data points kept as a file. These data points represent the SaO2 every 2 seconds during the monitored period. The resuscitation teams will utilize the pulse oximeter to determine if additional oxygen is required and to evaluate the effectiveness of resuscitation. In addition, we will review the data collected by the pulse oximeter to observe the change in SaO2 with delivery and resuscitation.

We have the capability to perform video recordings and will follow the methodology of Carbine et al. A video camera is mounted on the overhead warmer, loaded with a blank Mini-DV tape. The camera will be turned to record mode just prior to the initiation of the resuscitation. Following completion of the resuscitation, the recorder will be turned off, and the tape removed and placed in a secure location till reviewed and scored. All collected videotapes will be centrally reviewed by the research team to ensure consistency of scoring. All tapes will be erased following review, and the scoring sheets completed during the video reviews will be maintained as research data, and stored for as long as required.

Protocol Violations

We anticipate that there will be occasional protocol violations. These may be as follows:

Failure to complete resuscitation using the randomized Oxygen level. Failure to increase the FiO2 as required by protocol ( presence of bradycardia (HR< 100 bpm for 2 minutes), and/or poor color or an SaO2 < 70% at 3 minutes by SaPO2)

Adverse Events:

As this will be a very vulnerable population, we expect that there will be serious adverse events including death.

Adverse events which may be related to the study maneuver would include:

  1. Prolonged hypoxia and/or failure to respond to resuscitation
  2. The need for chest compressions, and/or epinephrine These will be noted from the video review and chart documentation

Measures of Oxidant Stress: Blood from the Cord and subsequent specimens from the infant at 1 hour, 1 week and 1 month will be obtained, 400 microlitres, 4/10th of an ml for a total of 1.2 ml from the infant, spun and frozen and run at our basic science laboratory for measurement of lipid peroxides, oxidized and reduced glutathione and total antioxidant status. Lipid peroxides will be measured using the K-ASSAY kit from the Kamiya Biomedical company. Total antioxidant status will be measured using the Randox Total Antioxidant status kit.

Study Type

Interventional

Enrollment

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92103
        • University of California San Diego Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • known chromosomal or congenital anomalies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
total antioxidant status
lipid peroxide levels
oxygen saturations

Secondary Outcome Measures

Outcome Measure
Death
Periventricular leukomalacia
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
Retinopathy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neil Finer

Investigators

  • Principal Investigator: Neil N Finer, MD, University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2005

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

August 28, 2006

First Submitted That Met QC Criteria

August 28, 2006

First Posted (Estimate)

August 29, 2006

Study Record Updates

Last Update Posted (Actual)

October 4, 2019

Last Update Submitted That Met QC Criteria

October 2, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 051169

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prematurity

Clinical Trials on Titration of oxygen in delivery room

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe