Neonatal Respiratory FailureNCT01675388
Hypothermia During ECMO to Decrease Brain Injury
A study testing Hypothermia in people with Neonatal Respiratory Failure, run by Sood, Beena G., MD, MS at 1 site in United States.
Trial summary
Newborn infants with severe respiratory failure are treated with extracorporeal membrane oxygenation (ECMO), a modified form of cardiopulmonary bypass. These infants as at risk for brain injury as a result of hypoxia and blood flow changes in the brain prior to and during ECMO. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Neonatal Respiratory Failure
- What is being tested?
- Hypothermia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Aug 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 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates ≥ 34 weeks gestational age and postnatal age ≤ 28 days
- Presence of severe reversible NHRF qualifying for ECMO based on institutional guidelines including:
- Oxygenation Index > 35 ([mean airway pressure in cmH2O x Fractional inspired O2 concentration x 100]/Arterial O2 tension in mmHg) or
- Alveolar-arterial oxygen gradient > 600 mmHg for 4 h
- Infants undergoing veno-arterial or veno-venous ECMO
Who cannot join
- Lethal chromosomal and congenital anomalies including congenital diaphragmatic hernia (CDH) Infants with CDH, who constitute a third of neonates undergoing ECMO, have been excluded because the high mortality and morbidity is related more to the underlying lung abnormality and practice variation in timing of CDH repair rather than to NHRF.
- ECMO for post operative cardiac support
- Neonates with a birth weight < 1.8 kg
- Initiation of HYP for NE prior to initiating ECMO for NHRF
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Michigan
Detroit, Michigan, 48201
About this study
Official title: Hypothermia as Neuroprotection During ECMO: Is Brain MRI a Biomarker of Outcomes?
Newborn infants with severe respiratory failure are treated with extracorporeal membrane oxygenation (ECMO), a modified form of cardiopulmonary bypass. These infants as at risk for brain injury as a result of hypoxia and blood flow changes in the brain prior to and during ECMO. The investigators propose a clinical trial of a novel treatment (cooling during ECMO) and novel diagnostic tool (advanced MRI techniques) that will lead to improved outcomes, early diagnosis and intervention for brain injury, decreased cost and duration of clinical trials, decrease in the burden of chronic neurologic disease and disability in society, thus improving the health and quality of life of these infants as they progress through childhood into adulthood.
Read the detailed description
Term and late preterm neonates with severe hypoxemic respiratory failure [NHRF] receive extracorporeal membrane oxygenation (ECMO), a modified form of cardiopulmonary bypass, when maximal conventional therapy fails. Although ECMO significantly improves survival and decreases disability, 15-50% of survivors nevertheless have poor neurodevelopmental [ND] outcomes due to hypoxemia and cerebral hypoperfusion occurring prior to and during ECMO. Hypothermia [HYP] (33 deg-34 deg C for 48-72 hours) has been shown to improve ND outcomes and following neonatal hypoxic-ischemic encephalopathy [NE]. Whether the addition of hypothermia to ECMO for severe NHRF will improve ND outcomes is unknown. Long-term evaluation of ND outcomes is the gold standard for determining the full spectrum of developmental disabilities as neonatal clinical findings; biochemical and electrophysiological tests; and cranial sonography have limited predictive value. Conventional magnetic resonance imaging [MRI] has a predictive accuracy of > 0.8 for death and disability following NE. MR abnormalities in infants undergoing ECMO for NHRF differ from those seen in NE and there are no systematic reports on the ND implications of MR abnormalities seen in NHRF treated with ECMO. Given the societal and economic costs associated with poor long-term ND outcomes and the challenges of neurologic assessment in critically ill neonates receiving ECMO for NHRF, there is an urgent need for (i) neuroprotection pre-/during ECMO to decrease brain injury and (ii) innovative diagnostic modalities to enable early diagnosis and intervention.
Our goal is to improve the treatment and ND outcomes in neonates with NHRF. The overall objectives of this proposal are to establish the neuroprotective role of hypothermia during ECMO for NHRF as evaluated by ND assessment at 18-22 months [mo] of age and to validate the use of conventional and advanced MR techniques as biomarkers of brain injury. The central hypotheses are that (i) HYP to 33.5°C during the 1st 72 hours of ECMO in NHRF will reduce the extent and severity of brain injury as evaluated by Bayley Scales of Infant Development (BSID-III) cognitive scores at 18-22 mo and proportion of normal MRI studies in the neonatal period and at 18-22 mo; and (ii) conventional and advanced MR techniques in the neonatal period and at 18-22 mo will be biomarkers of brain injury allowing prediction of ND outcomes, and monitoring of post-injury brain growth and plasticity.
The specific aims are to evaluate:
- Safety and efficacy of hypothermia combined with ECMO for NHRF in improving neurodevelopmental outcomes at 18-22 months of age
- MR abnormalities in the neonatal period and at 18-22 months of age and their predictive accuracy for neurodevelopmental outcomes at 18-22 months of age following hypothermia during ECMO for NHRF
MRI will be obtained in the neonatal period as part of routine clinical care; MRI will be repeated at 18-22 mo of age on an outpatient basis if funding is available to assess longitudinal changes in brain structure and metabolite profile following ECMO for NHRF and to correlate these with ND outcomes at 18-22 mo of age.
- Conditions
- Neonatal Respiratory Failure
- Being tested
- Hypothermia
- Keywords
- Neonatal hypoxemic respiratory failure, Extra Corporeal Membrane Oxygenation, Neurodevelopmental outcomes, Neuroimaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypothermiaOther
Hypothermia to 33.5 deg C
| Study group | Role | What they receive |
|---|---|---|
| Hypothermia | Experimental | Hypothermia to 33.5 deg Centigrade Receives: Other: Hypothermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
BSID-III cognitive scores at 18-22 mo
Measured: 18-22 months of age
Secondary outcomes (2)
Clinical findings in the neonatal period and at 18-22 mos
- outcomes in the neonatal intensive care unit (NICU): HUS findings, type of ECMO, death/withdrawal of intensive care, acute AEs, cardio-respiratory support, infections, need for gavage/gastrostomy-tube feeds, length of hospital stay, bronchopulmonary dysplasia, neurologic status, and growth parameter at discharge ii) outcomes after discharge: post-neonatal deaths, number of re-hospitalizations, seizure disorder, growth parameters, BSID-III subscales at 18-22 mo, visual impairment, hearing impairment, multiple disabilities
Measured: 18-22 months
MRI findings in the neonatal period and at 18-22 mos
MRIs at 18-22 months will only be evaluated if funding for obatining MRIs becomes available
Measured: 18-22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Respiratory FailureStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sood, Beena G., MD, MS
- Responsible party
- Principal investigator, Beena G. Sood, MD, MS, Sood, Beena G., MD, MS
- Investigators
- Beena G. Sood, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01675388
- Sponsor's protocol ID
- 1006008466
- Status last verified
- Nov 2014
- First submitted
- 24 Aug 2012
- Last updated
- 18 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypothermia as Neuroprotection During ECMO: Is Brain MRI a Biomarker of Outcomes?
- ClinicalTrials.gov ID
- NCT01675388
- Acronym / sponsor ID
- 1006008466
- Conditions
- Neonatal Respiratory Failure
- Keywords
- Neonatal hypoxemic respiratory failure, Extra Corporeal Membrane Oxygenation, Neurodevelopmental outcomes, Neuroimaging
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sood, Beena G., MD, MS
- Study start
- Aug 2012
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 30 Aug 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.
Newborn infants with severe respiratory failure are treated with extracorporeal membrane oxygenation (ECMO), a modified form of cardiopulmonary bypass. These infants as at risk for brain injury as a result of hypoxia and blood flow changes in the brain prior to and during ECMO. The investigators propose a clinical trial of a novel treatment (cooling during ECMO) and novel diagnostic tool (advanced MRI techniques) that will lead to improved outcomes, early diagnosis and intervention for brain injury, decreased cost and duration of clinical trials, decrease in the burden of chronic neurologic disease and disability in society, thus improving the health and quality of life of these infants as they progress through childhood into adulthood.
Detailed description
Term and late preterm neonates with severe hypoxemic respiratory failure [NHRF] receive extracorporeal membrane oxygenation (ECMO), a modified form of cardiopulmonary bypass, when maximal conventional therapy fails. Although ECMO significantly improves survival and decreases disability, 15-50% of survivors nevertheless have poor neurodevelopmental [ND] outcomes due to hypoxemia and cerebral hypoperfusion occurring prior to and during ECMO. Hypothermia [HYP] (33 deg-34 deg C for 48-72 hours) has been shown to improve ND outcomes and following neonatal hypoxic-ischemic encephalopathy [NE]. Whether the addition of hypothermia to ECMO for severe NHRF will improve ND outcomes is unknown. Long-term evaluation of ND outcomes is the gold standard for determining the full spectrum of developmental disabilities as neonatal clinical findings; biochemical and electrophysiological tests; and cranial sonography have limited predictive value. Conventional magnetic resonance imaging [MRI] has a predictive accuracy of > 0.8 for death and disability following NE. MR abnormalities in infants undergoing ECMO for NHRF differ from those seen in NE and there are no systematic reports on the ND implications of MR abnormalities seen in NHRF treated with ECMO. Given the societal and economic costs associated with poor long-term ND outcomes and the challenges of neurologic assessment in critically ill neonates receiving ECMO for NHRF, there is an urgent need for (i) neuroprotection pre-/during ECMO to decrease brain injury and (ii) innovative diagnostic modalities to enable early diagnosis and intervention.
Our goal is to improve the treatment and ND outcomes in neonates with NHRF. The overall objectives of this proposal are to establish the neuroprotective role of hypothermia during ECMO for NHRF as evaluated by ND assessment at 18-22 months [mo] of age and to validate the use of conventional and advanced MR techniques as biomarkers of brain injury. The central hypotheses are that (i) HYP to 33.5°C during the 1st 72 hours of ECMO in NHRF will reduce the extent and severity of brain injury as evaluated by Bayley Scales of Infant Development (BSID-III) cognitive scores at 18-22 mo and proportion of normal MRI studies in the neonatal period and at 18-22 mo; and (ii) conventional and advanced MR techniques in the neonatal period and at 18-22 mo will be biomarkers of brain injury allowing prediction of ND outcomes, and monitoring of post-injury brain growth and plasticity.
The specific aims are to evaluate:
- Safety and efficacy of hypothermia combined with ECMO for NHRF in improving neurodevelopmental outcomes at 18-22 months of age
- MR abnormalities in the neonatal period and at 18-22 months of age and their predictive accuracy for neurodevelopmental outcomes at 18-22 months of age following hypothermia during ECMO for NHRF
MRI will be obtained in the neonatal period as part of routine clinical care; MRI will be repeated at 18-22 mo of age on an outpatient basis if funding is available to assess longitudinal changes in brain structure and metabolite profile following ECMO for NHRF and to correlate these with ND outcomes at 18-22 mo of age.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypothermia | Experimental | Other: HypothermiaHypothermia to 33.5 deg Centigrade |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Neonates ≥ 34 weeks gestational age and postnatal age ≤ 28 days
- Presence of severe reversible NHRF qualifying for ECMO based on institutional guidelines including:
- Infants undergoing veno-arterial or veno-venous ECMO
Key exclusion criteria (4 listed)
- Lethal chromosomal and congenital anomalies including congenital diaphragmatic hernia (CDH) Infants with CDH, who constitute a third of neonates undergoing ECMO, have been excluded because the high mortality and morbidity is related more to the underlying lung abnormality and practice variation in timing of CDH repair rather than to NHRF.
- ECMO for post operative cardiac support
- Neonates with a birth weight < 1.8 kg
- Initiation of HYP for NE prior to initiating ECMO for NHRF
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 |
|---|---|---|
| HypothermiaHypothermia to 33.5 deg C | Other | Hypothermia |
Primary outcome
BSID-III cognitive scores at 18-22 mo
Time frame: 18-22 months of age
2 secondary outcomes
Clinical findings in the neonatal period and at 18-22 mos
Time frame: 18-22 months
MRI findings in the neonatal period and at 18-22 mos
Time frame: 18-22 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2014.
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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.
Beena G. Sood principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypothermia in people with Neonatal Respiratory Failure, run by Sood, Beena G., MD, MS 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 5 inclusion and 4 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: withdrawn, as of the sponsor's last update on 18 Nov 2014. 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 was withdrawn before enrolling participants, so there are no results.
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?
BSID-III cognitive scores at 18-22 mo (time frame: 18-22 months of age). 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 18 Nov 2014.