Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00369720
Status:
COMPLETED
Last Update Posted:
2019-10-04
First Post:
2006-08-28
Brief Title:
Use of Blended Oxygen for Delivery Room Resuscitation of Very Low Birth Weight Infants
Sponsor:
Neil Finer
Organization:
University of California San Diego
Study Overview
Official Title:
Use of Blended Oxygen for Delivery Room Resuscitation of VLBW Infants
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ventilationperfusion 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
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 ventilationperfusion 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
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 infants SaO2 remains less than 60 at two minutes less than 70 at 3 minutes andor 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 infants 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 infants 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 andor 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 andor failure to respond to resuscitation
2 The need for chest compressions andor 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 410th of an ml for a total of 12 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
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 infants SaO2 remains less than 60 at two minutes less than 70 at 3 minutes andor 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 infants 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 infants 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 andor 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 andor failure to respond to resuscitation
2 The need for chest compressions andor 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 410th of an ml for a total of 12 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None