Extreme Prematurity - Less Than 28 WeeksPRESOXNCT01773746
Study of Room Air Versus 60% Oxygen for Resuscitation of Premature Infants
A study testing Neonatal Resuscitation in people with Extreme Prematurity - Less Than 28 Weeks, run by Sharp HealthCare at 22 sites in 12 countries.
Trial summary
The most appropriate initial oxygen concentration for the resuscitation of the extremely low birth weight infant has not been established using large well designed, randomized, blinded, prospective trials and the level of oxygen utilized by practitioners in this situation is highly variable. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Extreme Prematurity - Less Than 28 Weeks
- What is being tested?
- Neonatal Resuscitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 22 sitesin 12 countries
- Study dates
- Aug 2013to 1 Mar 2017
- 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
- Infants with a gestational age of 23 0/7 to 28 6/7 weeks by best obstetrical estimate.
- Infants who will receive full resuscitation as necessary, i.e., no parental request or physician decision to forego resuscitation Infants whose parents/legal guardians have provided consent for enrollment, or for whom a waiver of consent is in place Infants without known major congenital malformations prior to delivery
Who cannot join
- Any infant transported to the center after delivery Infants whose parents/legal guardians refuse consent Infants born when the research apparatus/study personnel are not available Infants < 23 weeks 0 days or > 28 weeks 6 days, completed weeks of gestation
Trial locations and contacts
22 sites in 12 countries.
22 sites in 12 countries
United States6 sites
Connecticut Children's Medical Center
Farmington, Connecticut, 06030-2948
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Miami Miller School of Medicine
Miami, Florida, 33101
Oklahoma University Health Sciences Center
Oklahoma City, Oklahoma, 73104
Sharp Mary Birch Hospital for Women and Newborns
San Diego, California, 92123
OU - Tulsa - Saint Francis Hospital
Tulsa, Oklahoma, 74135
Spain4 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Saint Joan de Deu
Barcelona
Hospital Clinico San Carlos
Madrid
Hospital La Fe
Valencia
Austria2 sites
Innsbruck Medical University
Innsbruck
Medical University of Vienna
Vienna, 1090
Italy2 sites
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan
University of Siena
Siena
Russia1 site
St. Petersberg State Pediatric Medical University
Saint Petersberg
About this study
Official title: The Premature Infants Resuscitated With Oxygen or Air (PRESOX) Trial
The most appropriate initial oxygen concentration for the resuscitation of the extremely low birth weight infant has not been established using large well designed, randomized, blinded, prospective trials and the level of oxygen utilized by practitioners in this situation is highly variable. This proposed trial will use targeted oxygen saturation levels over the first 15 to 20 minutes of life to compare a low and a higher initial oxygen level for the resuscitation of such infants, and will be large enough to evaluate short term outcomes of survival without oxygen at 36 weeks and survival without retinopathy of prematurity, and the long term outcome of survival without significant neurodevelopmental impairment at 2 years of age. Such information is urgently required to provide an evidence basis for the initial oxygen concentration for resuscitation of these very preterm infants.
Read the detailed description
The Premature Infants Resuscitated with Oxygen or Air (PRESOX) trial, is a prospective randomized clinical trial of extremely premature infants that will assess the use of a low and high oxygen concentration for the initial resuscitation. The hypothesis is that infants resuscitated with a lower oxygen concentration at birth will have a increase in survival without bronchopulmonary dysplasia (BPD) or retinopathy of prematurity (ROP) during their initial hospitalization, and will have a increase in survival without neurodevelopmental impairments.
Previous studies of mostly term newborn infants have demonstrated that initial resuscitation with room air compared to 100% oxygen resulted in improved outcomes and an overall decrease in mortality. The analysis of these studies demonstrated that the reduction in mortality was very significant in the preterm infants that had been included in these trials. A number of small clinical trials have now demonstrated that it is feasible to treat very preterm infants with lower versus higher concentrations of oxygen while carefully monitoring their oxygen saturation in the minutes following delivery. As review of the previous observations demonstrated that there was a reduction in death using lower oxygen concentration, it is imperative that a large study of preterm infants be conducted to determine if a lower compared to a higher oxygen concentration for the initial resuscitation will lead to improved short and longer term outcomes including survival without neurodevelopmental disability.
The PRESOX trial will randomize infants from 23 weeks gestation to 28 weeks gestation who require resuscitation at birth to receive either room air or 60% oxygen. Oxygen saturation will be monitored from the first minute of life and the initial oxygen concentration will be titrated using a unique purpose built device which will track the oxygen saturation (SpO2) within the chosen target limits. The targets chosen allow the infants oxygen saturation to follow the increase seen in normal preterm infants who do not require resuscitation. Following resuscitation the infants will be transferred to the Neonatal Intensive Care Unit and management will follow the usual care in those units. In a subset of infants, levels of antioxidants from the infant's blood and urine will be measured by Dr M Vento. This portion of the study is already funded by the combined Spanish Ministries of Health and Science. Antioxidants are known to increase with exposure to oxygen. The infants will return for a neurodevelopmental follow up examination at the age of two years.
This trial will provide urgently needed evidence to establish the most optimal care to these very fragile preterm infants.
- Conditions
- Extreme Prematurity - Less Than 28 Weeks
- Being tested
- Neonatal Resuscitation
- Keywords
- neonatal, resuscitation, room air
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neonatal ResuscitationOther
CPAP or Positive Pressure Ventilation will be provided.
| Study group | Role | What they receive |
|---|---|---|
| Room Air | Active comparator | Neonatal Resuscitation using continuous positive airway pressure(CPAP) or positive pressure ventilation (PPV) will be provided with 21% oxygen. Infants will remain on 21% oxygen until they have a functioning oximeter when SpO2 will be managed as below. FiO2 will be increased by 10% increments when the infant's SpO2 is below the lower sat limit for 30 seconds and repeated if the SpO2 remains outside the limit for a subsequent interval of 30 seconds as often as is necessary to bring the SpO2 within the pre-specified range. The FiO2 will be decreased by 10% increments when the SpO2 is above the upper limit for 30 seconds and repeated if the SpO2 remains outside the limit for a subsequent interval of 30 second as often as is necessary to bring the SpO2 within the pre-specified range. Receives: Other: Neonatal Resuscitation |
| 60% Group | Active comparator | Neonatal Resuscitation using CPAP or PPV will be provided with 60% oxygen. Infants will remain on 60% oxygen until they have a functioning oximeter at which time their SpO2 will be managed as described below FiO2 will be increased by 10% increments when the infant's SpO2 is below the lower sat limit for 30 seconds and repeated if the SpO2 remains outside the limit for a subsequent interval of 30 seconds as often as is necessary to bring the SpO2 within the pre-specified range. The FiO2 will be decreased by 10% increments when the SpO2 is above the upper limit for 30 seconds and repeated if the SpO2 remains outside the limit for a subsequent interval of 30 second as often as is necessary to bring the SpO2 within the pre-specified range. Receives: Other: Neonatal Resuscitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival with neurodevelopmental impairment
To determine if resuscitation starting with 21% oxygen and a targeted SpO2 strategy will increase survival without significant neurodevelopmental impairment at 18 to 22 months when compared with starting with 60% oxygen and a targeted SpO2 strategy.
Measured: 18-22 mos.
Secondary outcomes (3)
Survival without bronchopulmonary dysplasia
- To determine if resuscitation of extremely low gestational age neonates (ELGAN) starting with 21% oxygen and a targeted SpO2 strategy will increase survival without bronchopulmonary dysplasia when compared with starting with 60% oxygen and a targeted SpO2 strategy.
Measured: 36 weeks
Survival without ROP
- To determine if resuscitation of extremely low gestational age neonates (ELGAN) starting with 21% oxygen and a targeted SpO2 strategy will increase survival without Retinopathy of Prematurity when compared with starting with 60% oxygen and a targeted SpO2 strategy.
Measured: 36 weeks
Decreased GSSG/GSH Ratio
- To determine if resuscitation starting with 21% oxygen and a targeted SpO2 strategy will result in decreased GSSG/GSH ratio concentrations and decreased production of isofurans when compared with starting with 60% oxygen and a targeted SpO2 strategy.
Measured: Birth,1,3,7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startAug 2013
- Primary completion1 Mar 2017
- Study completion1 Mar 2017
Why it stopped: Poor Recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extreme Prematurity - Less Than 28 WeeksStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sharp HealthCare
- Sponsor type
- University, hospital or other
- Collaborators
- Thrasher Research Fund
- Responsible party
- Principal investigator, Neil Finer, Sharp HealthCare
- Investigators
- Neil N Finer, MD, Principal investigator, UCSD Medical CenterMaximo Vento, MD, Principal investigator, Hospital La Fe, Valencia SpainOla D Saugstad, MD, PhD, Principal investigator, The National Hospital, Oslo Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01773746
- Sponsor's protocol ID
- 2012-3602
- Acronym
- PRESOX
- Status last verified
- Sep 2018
- First submitted
- 10 Jan 2013
- Last updated
- 12 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Premature Infants Resuscitated With Oxygen or Air (PRESOX) Trial
- ClinicalTrials.gov ID
- NCT01773746
- Acronym / sponsor ID
- PRESOX / 2012-3602
- Conditions
- Extreme Prematurity - Less Than 28 Weeks
- Keywords
- neonatal, resuscitation, room air
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor Recruitment
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sharp HealthCareUniversity, hospital or other
- Collaborators
- Thrasher Research Fund
- Study start
- Aug 2013
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 23 Jan 2013 (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.
The most appropriate initial oxygen concentration for the resuscitation of the extremely low birth weight infant has not been established using large well designed, randomized, blinded, prospective trials and the level of oxygen utilized by practitioners in this situation is highly variable. This proposed trial will use targeted oxygen saturation levels over the first 15 to 20 minutes of life to compare a low and a higher initial oxygen level for the resuscitation of such infants, and will be large enough to evaluate short term outcomes of survival without oxygen at 36 weeks and survival without retinopathy of prematurity, and the long term outcome of survival without significant neurodevelopmental impairment at 2 years of age. Such information is urgently required to provide an evidence basis for the initial oxygen concentration for resuscitation of these very preterm infants.
Detailed description
The Premature Infants Resuscitated with Oxygen or Air (PRESOX) trial, is a prospective randomized clinical trial of extremely premature infants that will assess the use of a low and high oxygen concentration for the initial resuscitation. The hypothesis is that infants resuscitated with a lower oxygen concentration at birth will have a increase in survival without bronchopulmonary dysplasia (BPD) or retinopathy of prematurity (ROP) during their initial hospitalization, and will have a increase in survival without neurodevelopmental impairments.
Previous studies of mostly term newborn infants have demonstrated that initial resuscitation with room air compared to 100% oxygen resulted in improved outcomes and an overall decrease in mortality. The analysis of these studies demonstrated that the reduction in mortality was very significant in the preterm infants that had been included in these trials. A number of small clinical trials have now demonstrated that it is feasible to treat very preterm infants with lower versus higher concentrations of oxygen while carefully monitoring their oxygen saturation in the minutes following delivery. As review of the previous observations demonstrated that there was a reduction in death using lower oxygen concentration, it is imperative that a large study of preterm infants be conducted to determine if a lower compared to a higher oxygen concentration for the initial resuscitation will lead to improved short and longer term outcomes including survival without neurodevelopmental disability.
The PRESOX trial will randomize infants from 23 weeks gestation to 28 weeks gestation who require resuscitation at birth to receive either room air or 60% oxygen. Oxygen saturation will be monitored from the first minute of life and the initial oxygen concentration will be titrated using a unique purpose built device which will track the oxygen saturation (SpO2) within the chosen target limits. The targets chosen allow the infants oxygen saturation to follow the increase seen in normal preterm infants who do not require resuscitation. Following resuscitation the infants will be transferred to the Neonatal Intensive Care Unit and management will follow the usual care in those units. In a subset of infants, levels of antioxidants from the infant's blood and urine will be measured by Dr M Vento. This portion of the study is already funded by the combined Spanish Ministries of Health and Science. Antioxidants are known to increase with exposure to oxygen. The infants will return for a neurodevelopmental follow up examination at the age of two years.
This trial will provide urgently needed evidence to establish the most optimal care to these very fragile preterm infants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Room Air | Active comparator | Other: Neonatal ResuscitationNeonatal Resuscitation using continuous positive airway pressure(CPAP) or positive pressure ventilation (PPV) will be provided with 21% oxygen. Infants will remain on 21% oxygen until they have a functioning oximeter when SpO2 will be managed as below. FiO2 will be increased by 10% increments when the infant's SpO2 is below the lower sat limit for 30 seconds and repeated if the SpO2 remains outside the limit for a subsequent interval of 30 seconds as often as is necessary to bring the SpO2 within the pre-specified range. The FiO2 will be decreased by 10% increments when the SpO2 is above the upper limit for 30 seconds and repeated if the SpO2 remains outside the limit for a subsequent interval of 30 second as often as is necessary to bring the SpO2 within the pre-specified range. |
| 60% Group | Active comparator | Other: Neonatal ResuscitationNeonatal Resuscitation using CPAP or PPV will be provided with 60% oxygen. Infants will remain on 60% oxygen until they have a functioning oximeter at which time their SpO2 will be managed as described below FiO2 will be increased by 10% increments when the infant's SpO2 is below the lower sat limit for 30 seconds and repeated if the SpO2 remains outside the limit for a subsequent interval of 30 seconds as often as is necessary to bring the SpO2 within the pre-specified range. The FiO2 will be decreased by 10% increments when the SpO2 is above the upper limit for 30 seconds and repeated if the SpO2 remains outside the limit for a subsequent interval of 30 second as often as is necessary to bring the SpO2 within the pre-specified range. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Infants with a gestational age of 23 0/7 to 28 6/7 weeks by best obstetrical estimate.
- Infants who will receive full resuscitation as necessary, i.e., no parental request or physician decision to forego resuscitation Infants whose parents/legal guardians have provided consent for enrollment, or for whom a waiver of consent is in place Infants without known major congenital malformations prior to delivery
Key exclusion criteria (1 listed)
- Any infant transported to the center after delivery Infants whose parents/legal guardians refuse consent Infants born when the research apparatus/study personnel are not available Infants < 23 weeks 0 days or > 28 weeks 6 days, completed weeks of gestation
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 |
|---|---|---|
| Neonatal ResuscitationCPAP or Positive Pressure Ventilation will be provided. | Other | 60% Group, Room Air |
Primary outcome
Survival with neurodevelopmental impairment
Time frame: 18-22 mos.
To determine if resuscitation starting with 21% oxygen and a targeted SpO2 strategy will increase survival without significant neurodevelopmental impairment at 18 to 22 months when compared with starting with 60% oxygen and a targeted SpO2 strategy.
3 secondary outcomes
Survival without bronchopulmonary dysplasia
Time frame: 36 weeks
Survival without ROP
Time frame: 36 weeks
Decreased GSSG/GSH Ratio
Time frame: Birth,1,3,7 days
Results and safety
The study was stopped early (reason given: Poor Recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
Related trials for Extreme Prematurity - Less Than 28 Weeks
RecruitingObservational study
The UK 22 Week Study
Extreme Prematurity - Less Than 28 Weeks, Infant, Extremely Premature
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.
Neil N Finer, MD principal investigator
UCSD Medical Center
Maximo Vento, MD principal investigator
Hospital La Fe, Valencia Spain
Ola D Saugstad, MD, PhD principal investigator
The National Hospital, Oslo Norway
22 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neonatal Resuscitation in people with Extreme Prematurity - Less Than 28 Weeks, run by Sharp HealthCare at 22 sites in 12 countries.
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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Spain, Austria, Italy, France and 7 more countries. 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 was stopped early (reason given: Poor Recruitment). Results are not available in the source record.
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?
Survival with neurodevelopmental impairment (time frame: 18-22 mos.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Sep 2018.