Circulatory FailureNCT02051894
NeoAdapt 3: Novel Biomarkers in the Evaluation of Neonatal Circulatory Insufficiency in Babies Suffering From Hypoxic Ischemic Encephalopathy
An observational study of Circulatory Failure, run by Brighton and Sussex University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
1 in 1000 babies are born suffering from a lack of oxygen. This is known as hypoxic ischemic encephalopathy (HIE). Infants with this condition can suffer multiple organ problems. Read more about this study
- Who is it for?
- Ages Up to 3 days
- Conditions the study is for
- Circulatory Failure
- What is being tested?
- Dobutamine
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2014to Sep 2016
- Phase
- Observational
- 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 Up to 3 days
- All sexes
- No healthy volunteers
- Child
Study population: Infants older than 36 weeks gestational age suffering from hypoxic ischemic encephalopathy receiving total body cooling
Who may be able to join
- Infants admitted to the NICU with HIE for total body cooling therapy
- Postnatal age <72 hours
- Parental informed consent
Who cannot join
- Non-viability
- Congenital hydrops or malformations likely to affect cardiovascular adaptation
- Surgery planned within 72 hours of birth
- Chromosomal anomalies
- Informed consent form (ICF) not signed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NeoAdapt 3: An Observational Study Investigating Novel Biomarkers in the Evaluation and Treatment of Neonatal Circulatory Insufficiency in Infants Suffering From Hypoxic Ischemic Encephalopathy.
1 in 1000 babies are born suffering from a lack of oxygen. This is known as hypoxic ischemic encephalopathy (HIE). Infants with this condition can suffer multiple organ problems. In particular it can affect how their hearts pump blood around their body thus leading to a poor blood supply to parts of their body such as the brain. This is known as circulatory failure and can contribute to poor long term outcomes such as cerebral palsy. To try and prevent brain damage these infants are treated with total body cooling, however this treatment can further effect how babies pump blood around the body, but also how drugs which may be used by in this condition are processed.
In order to assess and treat this condition doctors need to be able to accurately measure the blood supply in an infant. However there is no agreement on how best to do this. This makes decisions about when to treat an infant difficult. Sometimes doctors may want to use drugs such as dobutamine or adrenaline but these drugs are unlicensed in babies.
This study proposes to observe the way babies circulatory problems are treated in babies with HIE the in the first four days of life. In addition the study will look are two new measurements of a babies blood supply to see if they are a better measure of when an infant needs treatment. This will involve an ultrasound scan of the heart and measurement of the baby's oxygen levels from a probe placed on their hand. The study will also look at how the drug dobutamine is processed by babies. This will be done from two small extra blood tests. The aim of the study is to help clinicians refine the identification and treatment of circulatory failure in babies with HIE.
Read the detailed description
The current definitions of neonatal shock/circulatory failure are outdated, inaccurate and it is not be appropriate to apply to infants suffering from hypoxic ischemic encephalopathy he purpose of the this research is to look at older than 33 weeks gestational age in order to fill the knowledge gap here and help in the development a new definition of neonatal circulatory failure.
The main research questions are:-
- To investigate new non-invasive methods of assessing an infants circulatory status in infants suffering from HIE.
- To gain initial data on how dobutamine is processed by babies when they are used for circulatory failure.
- To observe how physicians decide to treat circulatory failure in infants suffering from HIE.
Research has shown that there is up to a 14 fold difference in how doctors assess and treat circulatory failure. In infants suffering from hypoxic ischemic encephalopathy this is complicated further by the fact that treatment with total body cooling can interfere further with how the body pumps blood around the body. This is further complicated by the fact there is no agreed definition for circulatory failure in infants. By investigating new methods of assessing a babies circulatory status we intend to help create a new definition of circulatory failure which will in turn help doctors create further studies to identify infants with circulatory failure and find the best ways of treating this condition in babies. So far research in this area has been concentrated in babies born at less than 33 weeks gestation. We extend the knowledge in the area to infants older that 36 weeks gestation suffering from hypoxic ischemic encephalopathy.
Dobutamine is a drug that does not have a license for use in infants. In the future all new drugs will need to be studied in children before a license for them is given. In addition the European Community are encouraging that research is undertaken to look into the use of old drugs in which are used in babies. As mentioned previously there is very little data to show how dobutamine is handled by babies and contribute to new information on how this drug should be given safely.
This will be an observational pilot study, to gain novel values of SVC flows and pleth values in infants with HIE being treated with total body cooling. In addition this population will be observed with regard to which diagnostic measures that lead to treatment decisions, especially with regards to haemodynamic stability, and what the effect of those decisions are on the various diagnostic measures. Decision-making for their treatment will be based on clinical guidelines in at the Trevor Mann Baby Unit and clinician preference.
The assessment of SVC flow and PVI will only be done every 24 hours whist the infant is receiving total body cooling and once during the re-warming phase of their treatment.
Primary Outcome Measure Values for SVCF and PVI in neonates with HIE admitted for total body cooling derived from Echo-D and plethysmographic studies .
Observed Clinical Outcome Measures
- MRI appearances
- Cranial US appearances
- CFM appearances The MRI will be reported and scored according to a system described by Rutherford et al to aid predict long term outcome. This will be performed within the first two weeks post-total body cooling treatment which is in keeping with national and local guidance.
The analysis of the findings on cranial ultrasound scan will be interpreted in the light of a baseline scan, to be performed as soon as possible after birth on enrolment, to avoid ascribing the effect of antenatal insults to postnatal events.
Those treated for HIE with total body cooling will have an additional daily neurological assessment during the cooling and re-warming phases of treatment that will be a graded according to criteria set out by Sarnat et al. This is routine in the treatment of this population of infants.
CFM recordings will be made during the cooling treatment phase of an infant. This is a standard observation in children with HIE and is associated with long term outcomes for these infants. For the purposes of the study the CFM will be used at the discretion of the attending medical team. The analysis of the CFM will follow what was used in the Toby Trial and is described in detail elsewhere.
Treatments for Circulatory Failure Infants will receive treatment according to the preference of the responsible physician. As is common practice, dobutamine, dopamine and/or other treatments (including other cardiovascular drugs and/or volume replacement therapy with normal saline) will be administered.
Dose of administration The dose of administration of dobutamine will be at the discretion of the responsible physician. We envisage that dobutamine will typically be started between 2.5 and 5 mcg/kg/min and increased in steps of 5 mcg/kg/min to a maximum of 20 mcg/kg/min with a given time frequency if no response is seen.
Any changes to the treatment strategy will be documented by the responsible physician.
Criteria for Up-Titration of Medication Dose escalation will be guided by clinical judgment. Clinicians will be asked to record the criteria they used in order to make this decision.
Criteria for Down-Titration Dose reduction will be guided by clinical judgment. Clinicians will be asked to record the criteria they used in order to make this decision.
Further treatment If there is no response to dobutamine at 20 mcgg/k/min or the clinical response is considered by the attending physician to be inadequate, further treatment will be at the discretion of the attending physician who will be asked to record the reasons for the change in treatment strategy as well as the additional treatment that is given to the patient.
Concomitant therapy There will be no per-protocol concomitant medication or treatment. Accordingly, other important co-interventions will follow specific centre protocols and will be recorded in the case record form.
PHARMACOKINETICS (PK) SUB-STUDY
Aim of the PK sub-studies The aim of the sub-study is to give preliminary information in order to try and construct a population PK model. Given the uncertainties regarding the PK of dobutamine in infants receiving total body cooling we shall assess its elimination half life. This is defined as the amount of time for the quantity of a concentration to fall by half.
Half-life sub-study We will perform a preliminary study on all the infants included in NeoAdapt 3 that receive dobutamine as treatment for haemodynamic insufficiency. Two blood samples, of 400 μl each, will be obtained from each of these patients. The first sample will be drawn after the end of the infusion, at the time when dobutamine ceases reaching the systemic circulation of the neonate, defined as time end (te).
The second sample will be taken at different study time points after the end of infusion:
- 5 min after te
- 15 min after te
- 45 min after te
- 2 hours after te
- 6 hours after te Two infants will be allocated to each time point. Sampling times will be assigned randomly to the patients.
Plasma samples will be sent to the laboratory for the quantification of dobutamine.
- Conditions
- Circulatory Failure
- Being tested
- Dobutamine
- Keywords
- Neonates, Dobutamine, Superior Vena Cana Flow, Hypoxic Ischemic Encephalopathy, Pleth Variability Index
- Medical subject headings
- Shock, Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DobutamineDrug
Infants will receive treatment according to the preference of the responsible physician. As is common practice, dobutamine, dopamine and/or other treatments (including other cardiovascular drugs and/or volume replacement therapy with normal saline) will be administered.
If dobutamine is used we will take a maximum of two blood samples from the baby for pharmacokinetic analysis.
| Study group | Role | What they receive |
|---|---|---|
| HIE Group | Not described Receives: Drug: Dobutamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superior Vena Cava Flow (SVCF) in babys recieving total body cooling for Hypoxic Ischemic Encephalopathy
After consent and enrolment, Echo-D assessments will be repeated every 24 of cooling treatment (first 72 hours of postnatal life) and once during the re-warming phase (typically taking 8 hours after cooling has finished). The change in this measurement over the cooling treatment will be recorded.
Measured: Once a day for a maximum of three days after birth
Pleth Variability Index (PVI) in infants undergoing total body cooling treatment for hypoxic ischemic encephalopathy
After consent and enrolment PVI assessments will be repeated every 24 of cooling treatment (first 72 hours of postnatal life) and once during the re-warming phase (typically taking 8 hours after cooling has finished). The changes in the PVI measurements will be recorded over the course of cooling therapy.
Measured: Once a day for a maximum of three days after birth
Pharmacokinetic data for the emilmination half life of dobutamine when this drug is given for circulatory failure
If dobutamine is given for circulatory insufficiency in the first three days of life 2 blood samples will be taken for pharmacokinetic analysis of dobutamine.
Measured: If dobutamine is given to an infant in the first three days of life
Secondary outcomes (3)
SVCF and PVI values corrleation to each other and to parameters that assess circulatory status such as mean blood pressure and capillary refill time
Correlation analysis will be used to determine if there is an association between SVCF and PVI values to common parameters that are used in the neonatal intensive care setting to assess the haemodynamic status of an infant.
Measured: Over the first 3 days of life
SVCF and PVI values relationship to clinical outcomes
Clinical outcomes for infants who are suffering from hypoxic ischemic encephalopathy, such as MRI appearances, will be recorded. These outcomes will be compared to the SVCF and PVI values gained to see if either measurement is predictive of such clinical outcomes.
Measured: Over the first three days of life
SVCF and PVI values and dobutamine treatment for circulatory failure
Comparisons between the will be made between SVCF and PVI values gained from infants who were and those who were not receiving dobutamine at the time of these measurements to see if there is a significant difference between the values gained.
Measured: Over the first three days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circulatory 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brighton and Sussex University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- European Union
- Responsible party
- Principal investigator, Dr Liam Mahoney, Brighton and Sussex University Hospitals NHS Trust
- Investigators
- Liam Mahoney, B, Principal investigator, Brighton & Sussex Medical School/Brighton & Sussex Universitys NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02051894
- Sponsor's protocol ID
- IRAS: 145271
- Status last verified
- Sep 2016
- First submitted
- 27 Jan 2014
- Last updated
- 5 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NeoAdapt 3: An Observational Study Investigating Novel Biomarkers in the Evaluation and Treatment of Neonatal Circulatory Insufficiency in Infants Suffering From Hypoxic Ischemic Encephalopathy.
- ClinicalTrials.gov ID
- NCT02051894
- Acronym / sponsor ID
- IRAS: 145271
- Conditions
- Circulatory Failure
- Keywords
- Neonates, Dobutamine, Superior Vena Cana Flow, Hypoxic Ischemic Encephalopathy, Pleth Variability Index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Brighton and Sussex University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- European Union
- Study start
- Sep 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 31 Jan 2014 (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.
1 in 1000 babies are born suffering from a lack of oxygen. This is known as hypoxic ischemic encephalopathy (HIE). Infants with this condition can suffer multiple organ problems. In particular it can affect how their hearts pump blood around their body thus leading to a poor blood supply to parts of their body such as the brain. This is known as circulatory failure and can contribute to poor long term outcomes such as cerebral palsy. To try and prevent brain damage these infants are treated with total body cooling, however this treatment can further effect how babies pump blood around the body, but also how drugs which may be used by in this condition are processed.
In order to assess and treat this condition doctors need to be able to accurately measure the blood supply in an infant. However there is no agreement on how best to do this. This makes decisions about when to treat an infant difficult. Sometimes doctors may want to use drugs such as dobutamine or adrenaline but these drugs are unlicensed in babies.
This study proposes to observe the way babies circulatory problems are treated in babies with HIE the in the first four days of life. In addition the study will look are two new measurements of a babies blood supply to see if they are a better measure of when an infant needs treatment. This will involve an ultrasound scan of the heart and measurement of the baby's oxygen levels from a probe placed on their hand. The study will also look at how the drug dobutamine is processed by babies. This will be done from two small extra blood tests. The aim of the study is to help clinicians refine the identification and treatment of circulatory failure in babies with HIE.
Detailed description
The current definitions of neonatal shock/circulatory failure are outdated, inaccurate and it is not be appropriate to apply to infants suffering from hypoxic ischemic encephalopathy he purpose of the this research is to look at older than 33 weeks gestational age in order to fill the knowledge gap here and help in the development a new definition of neonatal circulatory failure.
The main research questions are:-
- To investigate new non-invasive methods of assessing an infants circulatory status in infants suffering from HIE.
- To gain initial data on how dobutamine is processed by babies when they are used for circulatory failure.
- To observe how physicians decide to treat circulatory failure in infants suffering from HIE.
Research has shown that there is up to a 14 fold difference in how doctors assess and treat circulatory failure. In infants suffering from hypoxic ischemic encephalopathy this is complicated further by the fact that treatment with total body cooling can interfere further with how the body pumps blood around the body. This is further complicated by the fact there is no agreed definition for circulatory failure in infants. By investigating new methods of assessing a babies circulatory status we intend to help create a new definition of circulatory failure which will in turn help doctors create further studies to identify infants with circulatory failure and find the best ways of treating this condition in babies. So far research in this area has been concentrated in babies born at less than 33 weeks gestation. We extend the knowledge in the area to infants older that 36 weeks gestation suffering from hypoxic ischemic encephalopathy.
Dobutamine is a drug that does not have a license for use in infants. In the future all new drugs will need to be studied in children before a license for them is given. In addition the European Community are encouraging that research is undertaken to look into the use of old drugs in which are used in babies. As mentioned previously there is very little data to show how dobutamine is handled by babies and contribute to new information on how this drug should be given safely.
This will be an observational pilot study, to gain novel values of SVC flows and pleth values in infants with HIE being treated with total body cooling. In addition this population will be observed with regard to which diagnostic measures that lead to treatment decisions, especially with regards to haemodynamic stability, and what the effect of those decisions are on the various diagnostic measures. Decision-making for their treatment will be based on clinical guidelines in at the Trevor Mann Baby Unit and clinician preference.
The assessment of SVC flow and PVI will only be done every 24 hours whist the infant is receiving total body cooling and once during the re-warming phase of their treatment.
Primary Outcome Measure Values for SVCF and PVI in neonates with HIE admitted for total body cooling derived from Echo-D and plethysmographic studies .
Observed Clinical Outcome Measures
- MRI appearances
- Cranial US appearances
- CFM appearances The MRI will be reported and scored according to a system described by Rutherford et al to aid predict long term outcome. This will be performed within the first two weeks post-total body cooling treatment which is in keeping with national and local guidance.
The analysis of the findings on cranial ultrasound scan will be interpreted in the light of a baseline scan, to be performed as soon as possible after birth on enrolment, to avoid ascribing the effect of antenatal insults to postnatal events.
Those treated for HIE with total body cooling will have an additional daily neurological assessment during the cooling and re-warming phases of treatment that will be a graded according to criteria set out by Sarnat et al. This is routine in the treatment of this population of infants.
CFM recordings will be made during the cooling treatment phase of an infant. This is a standard observation in children with HIE and is associated with long term outcomes for these infants. For the purposes of the study the CFM will be used at the discretion of the attending medical team. The analysis of the CFM will follow what was used in the Toby Trial and is described in detail elsewhere.
Treatments for Circulatory Failure Infants will receive treatment according to the preference of the responsible physician. As is common practice, dobutamine, dopamine and/or other treatments (including other cardiovascular drugs and/or volume replacement therapy with normal saline) will be administered.
Dose of administration The dose of administration of dobutamine will be at the discretion of the responsible physician. We envisage that dobutamine will typically be started between 2.5 and 5 mcg/kg/min and increased in steps of 5 mcg/kg/min to a maximum of 20 mcg/kg/min with a given time frequency if no response is seen.
Any changes to the treatment strategy will be documented by the responsible physician.
Criteria for Up-Titration of Medication Dose escalation will be guided by clinical judgment. Clinicians will be asked to record the criteria they used in order to make this decision.
Criteria for Down-Titration Dose reduction will be guided by clinical judgment. Clinicians will be asked to record the criteria they used in order to make this decision.
Further treatment If there is no response to dobutamine at 20 mcgg/k/min or the clinical response is considered by the attending physician to be inadequate, further treatment will be at the discretion of the attending physician who will be asked to record the reasons for the change in treatment strategy as well as the additional treatment that is given to the patient.
Concomitant therapy There will be no per-protocol concomitant medication or treatment. Accordingly, other important co-interventions will follow specific centre protocols and will be recorded in the case record form.
PHARMACOKINETICS (PK) SUB-STUDY
Aim of the PK sub-studies The aim of the sub-study is to give preliminary information in order to try and construct a population PK model. Given the uncertainties regarding the PK of dobutamine in infants receiving total body cooling we shall assess its elimination half life. This is defined as the amount of time for the quantity of a concentration to fall by half.
Half-life sub-study We will perform a preliminary study on all the infants included in NeoAdapt 3 that receive dobutamine as treatment for haemodynamic insufficiency. Two blood samples, of 400 μl each, will be obtained from each of these patients. The first sample will be drawn after the end of the infusion, at the time when dobutamine ceases reaching the systemic circulation of the neonate, defined as time end (te).
The second sample will be taken at different study time points after the end of infusion:
- 5 min after te
- 15 min after te
- 45 min after te
- 2 hours after te
- 6 hours after te Two infants will be allocated to each time point. Sampling times will be assigned randomly to the patients.
Plasma samples will be sent to the laboratory for the quantification of dobutamine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIE Group | – | Drug: Dobutamine |
Who may qualify
- Ages
- Up to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants older than 36 weeks gestational age suffering from hypoxic ischemic encephalopathy receiving total body cooling
Key inclusion criteria (3 listed)
- Infants admitted to the NICU with HIE for total body cooling therapy
- Postnatal age <72 hours
- Parental informed consent
Key exclusion criteria (5 listed)
- Non-viability
- Congenital hydrops or malformations likely to affect cardiovascular adaptation
- Surgery planned within 72 hours of birth
- Chromosomal anomalies
- Informed consent form (ICF) not signed
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 |
|---|---|---|
| DobutamineInfants will receive treatment according to the preference of the responsible physician. As is common practice, dobutamine, dopamine and/or other treatments (including other cardiovascular drugs and/or volume replacement therapy with normal saline) will be administered. If dobutamine is used we will take a maximum of two blood samples from the baby for pharmacokinetic analysis. | Drug | HIE Group |
Primary outcome
Superior Vena Cava Flow (SVCF) in babys recieving total body cooling for Hypoxic Ischemic Encephalopathy
Time frame: Once a day for a maximum of three days after birth
After consent and enrolment, Echo-D assessments will be repeated every 24 of cooling treatment (first 72 hours of postnatal life) and once during the re-warming phase (typically taking 8 hours after cooling has finished). The change in this measurement over the cooling treatment will be recorded.
Pleth Variability Index (PVI) in infants undergoing total body cooling treatment for hypoxic ischemic encephalopathy
Time frame: Once a day for a maximum of three days after birth
After consent and enrolment PVI assessments will be repeated every 24 of cooling treatment (first 72 hours of postnatal life) and once during the re-warming phase (typically taking 8 hours after cooling has finished). The changes in the PVI measurements will be recorded over the course of cooling therapy.
Pharmacokinetic data for the emilmination half life of dobutamine when this drug is given for circulatory failure
Time frame: If dobutamine is given to an infant in the first three days of life
If dobutamine is given for circulatory insufficiency in the first three days of life 2 blood samples will be taken for pharmacokinetic analysis of dobutamine.
3 secondary outcomes
SVCF and PVI values corrleation to each other and to parameters that assess circulatory status such as mean blood pressure and capillary refill time
Time frame: Over the first 3 days of life
SVCF and PVI values relationship to clinical outcomes
Time frame: Over the first three days of life
SVCF and PVI values and dobutamine treatment for circulatory failure
Time frame: Over the first three days of life
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 5 Sep 2016.
- This is the main clinical trial the study is associated withLink provided by the sponsor.
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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.
Liam Mahoney, B principal investigator
Brighton & Sussex Medical School/Brighton & Sussex Universitys NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Circulatory Failure, run by Brighton and Sussex University Hospitals NHS Trust at 1 site in United Kingdom.
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 5 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 5 Sep 2016. 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 Kingdom. 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?
Superior Vena Cava Flow (SVCF) in babys recieving total body cooling for Hypoxic Ischemic Encephalopathy (time frame: Once a day for a maximum of three days after birth). The study lists 3 primary outcomes in all. 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 5 Sep 2016.