PrematurityNCT01697904
Trial of a Limited Versus Traditional Oxygen Strategy During Resuscitation in Premature Newborns
A study testing Titration of oxygen during newborn resuscitation in delivery room in people with Prematurity and Oxidative Stress, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Preterm infants are born with immature lungs and often require help with breathing shortly after birth. This traditionally involves administering 100% oxygen. Unfortunately, delivery of high oxygen concentrations leads to the production of free radicals that can injure many organ systems. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Prematurity, Oxidative Stress
- What is being tested?
- Titration of oxygen during newborn resuscitation in delivery room
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Inborn
- Gestation age 24 0/7 to 34 6/7
- Need for active resuscitation
Who cannot join
- Prenatally diagnosed cyanotic congenital heart disease
- Non-viable newborns
- Precipitous delivery and resuscitation team not present in the delivery room to initiate resuscitation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial of a Limited Versus Traditional Oxygen Strategy During Resuscitation in Premature Newborns
Preterm infants are born with immature lungs and often require help with breathing shortly after birth. This traditionally involves administering 100% oxygen. Unfortunately, delivery of high oxygen concentrations leads to the production of free radicals that can injure many organ systems. Term and near-term newborns deprived of oxygen during or prior to birth respond as well or better to resuscitation with room air (21% oxygen) compared to 100% oxygen. However, a static concentration of 21% oxygen may be inappropriate for preterm infants with lung disease.Purpose of the study is to investigate if preterm neonates where resuscitation is initiated with 21% fiO2 and adjusted to meet transitional goal saturations (Limited oxygen strategy or LOX) would have less oxidative stress as measured by the oxidative balance ratio of biological antioxidant potential/total hydroperoxide compared to infants where resuscitation is initiated with pure oxygen and titrated for targeted saturations of 85-94% (Traditional oxygen strategy or TOX). Secondary outcomes of interest included need for other delivery room resuscitation measures, respiratory support and ventilation/oxygenation status upon neonatal intensive care unit (NICU) admission, survival to hospital discharge, bronchopulmonary dysplasia and other short-term morbidities.
- Conditions
- Prematurity, Oxidative Stress
- Being tested
- Titration of oxygen during newborn resuscitation in delivery room
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titration of oxygen during newborn resuscitation in delivery roomProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Low Oxygen Strategy | Experimental | Resuscitation was initiated with room air (21% O2) for LOX infants. Supplemental oxygen was given if 1) the heart rate (HR) was less than 100 bpm after 30 seconds of effective ventilation, 2) the lower limits of goal saturations were not met. Targeted goal Pre-ductal saturations after birth were derived by approximation of the interquartile values for healthy term infants as reported by Kamlin et al and Dawson et al.FiO2 was increased or decreased by 10% in 30 second intervals as needed. If HR < 60 bpm after 30 seconds of effective ventilation , FiO2 was increased to 100% until the heart rate was stabilized.
Targeted Pre-ductal SpO2 After birth
1. min 60%-65%
2. min 65%-70%
3. min 70%-75%
4. min 75%-80%
5. min 80%-85%
10 min 85%-94% Receives: Procedure: Titration of oxygen during newborn resuscitation in delivery room |
| Traditional Oxygen strategy ( TOX) | Active comparator | Resuscitation for TOX infants was started with 100% O2 and adjusted every 30 seconds by 10% to meet the target oxygen saturation range of 85-94% Receives: Procedure: Titration of oxygen during newborn resuscitation in delivery room |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in mean oxidative balance ratio at 1 hour of life
Total hydroperoxide(TH), Biological antioxidant potential (BAP)were measured at 1 hour of life in all preterm infants. Oxidative balance ratio was calculated from this formula. Oxidative balance ratio = BAP/TH.
Measured: Cord blood and at 1 hour of life
Secondary outcomes (10)
Total oxygen load used during active resuscitation
Measured: First 10 minutes of life
Saturations achieved during first 10 minutes of life
Measured: First 10 minutes of life
Significant bradycardia ( HR<60 beats per minute) after 90 seconds in either group during active resuscitation
Measured: First 10 minutes of life
Time spent with saturation above 94% during active resuscitation
Measured: First 10 minutes of life
Need for respiratory support in the delivery room
Measured: First 10 minutes of life
Bronchopulmonary dysplasia
Measured: 36 weeks postconceptional age
Length of hospitalization
Measured: From date of randomization to date of discharge, expected average of 8 weeks
Retinopathy of Prematurity
Measured: 40 weeks postconceptional age
Neonatal mortality
Measured: 28 days of life
Death before discharge
Measured: From date of randomization to date of discharge, expected average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startAug 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PrematurityStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vishal Kapadia, University of Texas Southwestern Medical Center
- Investigators
- Vishal S Kapadia, MD, Principal investigator, UT SouthwesternMyra H Wyckoff, MD, Principal investigator, UT Southwestern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01697904
- Sponsor's protocol ID
- STU 052011-044
- Status last verified
- Sep 2012
- First submitted
- 25 Sep 2012
- Last updated
- 2 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Kapadia VS, Chalak LF, Sparks JE, Allen JR, Savani RC, Wyckoff MH. Resuscitation of preterm neonates with limited versus high oxygen strategy. Pediatrics. 2013 Dec;132(6):e1488-96. doi: 10.1542/peds.2013-0978. Epub 2013 Nov 11.
PubMed 24218465
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of a Limited Versus Traditional Oxygen Strategy During Resuscitation in Premature Newborns
- ClinicalTrials.gov ID
- NCT01697904
- Acronym / sponsor ID
- STU 052011-044
- Conditions
- Prematurity, Oxidative Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 2 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Preterm infants are born with immature lungs and often require help with breathing shortly after birth. This traditionally involves administering 100% oxygen. Unfortunately, delivery of high oxygen concentrations leads to the production of free radicals that can injure many organ systems. Term and near-term newborns deprived of oxygen during or prior to birth respond as well or better to resuscitation with room air (21% oxygen) compared to 100% oxygen. However, a static concentration of 21% oxygen may be inappropriate for preterm infants with lung disease.Purpose of the study is to investigate if preterm neonates where resuscitation is initiated with 21% fiO2 and adjusted to meet transitional goal saturations (Limited oxygen strategy or LOX) would have less oxidative stress as measured by the oxidative balance ratio of biological antioxidant potential/total hydroperoxide compared to infants where resuscitation is initiated with pure oxygen and titrated for targeted saturations of 85-94% (Traditional oxygen strategy or TOX). Secondary outcomes of interest included need for other delivery room resuscitation measures, respiratory support and ventilation/oxygenation status upon neonatal intensive care unit (NICU) admission, survival to hospital discharge, bronchopulmonary dysplasia and other short-term morbidities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Oxygen Strategy | Experimental | Procedure: Titration of oxygen during newborn resuscitation in delivery roomResuscitation was initiated with room air (21% O2) for LOX infants. Supplemental oxygen was given if 1) the heart rate (HR) was less than 100 bpm after 30 seconds of effective ventilation, 2) the lower limits of goal saturations were not met. Targeted goal Pre-ductal saturations after birth were derived by approximation of the interquartile values for healthy term infants as reported by Kamlin et al and Dawson et al.FiO2 was increased or decreased by 10% in 30 second intervals as needed. If HR < 60 bpm after 30 seconds of effective ventilation , FiO2 was increased to 100% until the heart rate was stabilized. Targeted Pre-ductal SpO2 After birth 1. min 60%-65% 2. min 65%-70% 3. min 70%-75% 4. min 75%-80% 5. min 80%-85% 10 min 85%-94% |
| Traditional Oxygen strategy ( TOX) | Active comparator | Procedure: Titration of oxygen during newborn resuscitation in delivery roomResuscitation for TOX infants was started with 100% O2 and adjusted every 30 seconds by 10% to meet the target oxygen saturation range of 85-94% |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Inborn
- Gestation age 24 0/7 to 34 6/7
- Need for active resuscitation
Key exclusion criteria (3 listed)
- Prenatally diagnosed cyanotic congenital heart disease
- Non-viable newborns
- Precipitous delivery and resuscitation team not present in the delivery room to initiate resuscitation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Titration of oxygen during newborn resuscitation in delivery room | Procedure or surgery | Low Oxygen Strategy, Traditional Oxygen strategy ( TOX) |
Primary outcome
Reduction in mean oxidative balance ratio at 1 hour of life
Time frame: Cord blood and at 1 hour of life
Total hydroperoxide(TH), Biological antioxidant potential (BAP)were measured at 1 hour of life in all preterm infants. Oxidative balance ratio was calculated from this formula. Oxidative balance ratio = BAP/TH.
10 secondary outcomes
Total oxygen load used during active resuscitation
Time frame: First 10 minutes of life
Saturations achieved during first 10 minutes of life
Time frame: First 10 minutes of life
Significant bradycardia ( HR<60 beats per minute) after 90 seconds in either group during active resuscitation
Time frame: First 10 minutes of life
Time spent with saturation above 94% during active resuscitation
Time frame: First 10 minutes of life
Need for respiratory support in the delivery room
Time frame: First 10 minutes of life
Bronchopulmonary dysplasia
Time frame: 36 weeks postconceptional age
Length of hospitalization
Time frame: From date of randomization to date of discharge, expected average of 8 weeks
Retinopathy of Prematurity
Time frame: 40 weeks postconceptional age
Neonatal mortality
Time frame: 28 days of life
Death before discharge
Time frame: From date of randomization to date of discharge, expected average of 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2012.
- Derived from this study: PubMed 24218465Kapadia VS, Chalak LF, Sparks JE, Allen JR, Savani RC, Wyckoff MH. Resuscitation of preterm neonates with limited versus high oxygen strategy. Pediatrics. 2013 Dec;132(6):e1488-96. doi: 10.1542/peds.2013-0978. Epub 2013 Nov 11.
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Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vishal S Kapadia, MD principal investigator
UT Southwestern
Myra H Wyckoff, MD principal investigator
UT Southwestern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Titration of oxygen during newborn resuscitation in delivery room in people with Prematurity and Oxidative Stress, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in mean oxidative balance ratio at 1 hour of life (time frame: Cord blood and at 1 hour of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01697904, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2012.