NeonatalHildaNeoHanNCT02379936
Evaluation of Lactate Dehydrogenase as Decision Support for Admissions to Neonatal Ward
A study testing The Neo Hilda, Traditional evaluation and iPhone 4S in people with Neonatal and Asphyxia, run by National Children's Hospital, Vietnam at 1 site in Vietnam.
Trial summary
The immediate newborn period is the period of highest morbidity in life. Early signs of serious disease are often vague and difficult to interpret for the non- specialist. Screening lists of clinical signs are useful but have unsatisfactory specificity or sensitivity, cover only one or two diseases, and are… Read more about this study
- Who is it for?
- Ages 2 minutes to 36 hours
- What is being tested?
- The Neo Hilda, Traditional evaluation and iPhone 4S
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 1 siteVietnam
- Study dates
- Aug 2013to Aug 2014
- 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 2 minutes to 36 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All children admitted to the neonatal ward above 32w of age, considered for blood sampling.
Who cannot join
- Parental consent missing
- Gestational age less than 33 weeks postnatal age above 36 hours
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Neonatal unit, National hospital of Pedriatrics
Hanoi, Hanoi, 18/879
About this study
Official title: Evaluation of a Point of Care Analyzer for Lactate Dehydrogenase, HildaNeo, as Support for Decisions When Admitting Newborn to the Neonatal Wards at NPH
The immediate newborn period is the period of highest morbidity in life. Early signs of serious disease are often vague and difficult to interpret for the non- specialist. Screening lists of clinical signs are useful but have unsatisfactory specificity or sensitivity, cover only one or two diseases, and are complicated to handle in low resource settings.
In critically ill newborns, organ failure to one or multiple organ systems is frequently seen due to inadequate circulation to the tissues. Critical disease will cause hypoxia ischemia of the cells in the affected organs followed by energy deficiency. Independently of the condition causing the energy deficiency this will start a series of events, which initially cause a leaking cell membrane leading to that intracellular components, i.e. the enzyme Lactate dehydrogenase (LDH), will leak out into the blood. Previous research in newborns suggests that LDH is a clinically interesting early predictor of serious illness and may thus serve as an important complement to the clinical examination. If the LDH level is elevated the health care personnel will realize that something is wrong and call for appropriate measures.
Read more
Today LDH analysis is performed at the Dept. of Clinical Chemistry with an inexpensive and accurate method. However, this method needs relatively large blood volumes and the delay between blood sampling and results is rather long, often several hours. In addition LDH is sensitive to hemolysis, which is quite common in blood sampling in newborns. When this is detected at the laboratory a new sample will be needed, thus delaying the result even more. Also, smaller health care facilities rarely have the laboratory equipment needed for the analysis of LDH.
The Swedish company Calmark Sweden AB is now launching a point-of-care technology for LDH analysis called "Hilda Neo". LDH is analyzed on an easy-to-use consumable test card together with an "App" on an ordinary smartphone (in the planned study, iPhone 4S). The result is presented within minutes and presence of hemolysis will be simultaneously detected on the device.
The investigators speculate that the use of such a LDH test could serve as a diagnostic help for health-care staff in Vietnam in making the decision when to send a potentially sick newborn to a higher level neonatal unit (in this case the NICU at NPH, Hanoi)
Read the detailed description
Patients and Methods At admission to NPH, newborn (GA >32 w, ≤36h old) infants referred to NPH with suspect or probable clinical signs of illness for which the physician on call considers that a blood sample is needed will be included in the study when a doctor taking part in the study is present at the ward. When a blood test is indicated, around 2 ml of blood is routinely drawn including an extra 0.1 ml blood for analysis of LDH using the Hilda Neo card.
When an infant fulfils the inclusion criteria the physician on duty will open a downloaded "App" on the provided smartphone and take a photo of the first page of the study protocol including the patients study number time of birth, and the result of the clinical investigation on a simple clinical score protocol. Then the physician presses a "randomise button" on the smartphone to randomise to using the Hilda Neo card or to routine care. If randomised to the Hilda Neo card use the "app" gives instructions how to use the card and guides through the different steps of the test. The result of the LDH test will be presented to the physician immediately at the point-of-care and can be used in the clinical decisions.
To prepare for a following study of the usefulness of LDH when deciding if a baby is ready for transfer from the NICU to ordinary care all included infants will have an LDH test at the routine clinical laboratory daily when other blood samples are drawn. The investigators believe that two LDH tests at 6 - 24 hour intervals are needed for that question. The reason for using two tests with an interval is that a high single LDH value can be expected in a large number of the infants because of the preceding disease while a decreasing value might be a better predictor of an improving status.
An evaluation protocol is filled in by the neonatologist in the ward 80-96h after admission or, if earlier, at discharge or death. The classification of the protocols into "need for" and "no need for intensive care resources" will be done independently by two senior neonatologists, both blinded to the LDH results from the Hilda card and the routine clinical laboratory.
The outcome that will be reported is the number of patients admitted to correct level of care, NICU or level 2 unit, in the two groups the admitting doctor has or has not access to plasma LDH respectively.
The definitions of correct or not correct admission level were:
- Admitted to NICU care: correct decision=The patient did fulfil the criteria for referral to NICU during the first 80 and 96h after admission.
- Admitted to NICU care: not correct decision=The patient did not fulfil the criteria for referral to NICU during the first 80 to 96h after admission.
- Admitted to level 2 unit: correct decision=The patient did not fulfil the criteria for referral to NICU during the first 80 to 96h after admission.
- Admitted to level 2 unit: not correct decision= The patient did fulfil the criteria for referral to NICU between 80 and 96h after admission The classification of the protocols into "fulfil or not fulfil the criteria for intensive care resources" was done independently by two senior neonatologists, both blinded to the LDH results from the Hilda card and the routine clinical laboratory.
The criteria for "fulfil the criteria for intensive care resources" were that shock-, ventilator-, CPAP- treatment, blood exchange, parenteral nutrition or other procedures demanding NICU capacity in the actual setting were performed during the first 80 - 96 hours after admission.
For calculation of the number of patients needed for the study outcome "right decision" in relation to "wrong decision" will be used, see below under Power.
The results will be recorded on the paper protocol forms, which are kept with the clinical record of the patient. The results will also be kept as a photo using the Smart phone App where it can be read only until the picture has been sent to the register. When the picture comes to the register it is identified only by its study number. Name and identity together with the study number is taken from the patient record to a separate register, which is securely kept by one authorized person in order for future supplementary information. The data recorded for the study are those normally recorded for a NICU patient and the doctors evaluation of the Hilda card.
The de-identified protocols will be saved, processed and analysed with the statistical program SPSS. Only persons involved in the study will have access to the data registered.
Based on going (Itzel et.al) and previously conducted research a LDH activity exceeding 600U/L will be considered as increased.
Power calculation In the investigators earlier study about 75% of the babies admitted to the NICU did not need intensive care procedures during the first week. To detect a reduction from 75 to 50% according to outcome above would need 58 patients in the test and the control group respectively. The control group here is the group that is not admitted to the NICU ward but to the ordinary care ward.
If there are technical or other problems with the Hilda Neo test that might influence the primary outcome the study will include 58 babies after the problem has been solved.
The background factors and the criteria for need of intensive care that will be noted are presented on the protocols, (n= 120+20 patients)
- Being tested
- The Neo Hilda, Traditional evaluation, iPhone 4S
- Keywords
- Classification, HIE, Infections, Lactate dehydrogenase, Intensive Care
- Medical subject headings
- Asphyxia, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Neo HildaDevice
Also called Neo Hilda, Calmark Sweden AB
This is a procedure that measures Lactate dehydrogenase in a fast and reliable way from only 10 microliter of blood. Using a small point of care card and a Smartphone for analysis.
Point of care method
Traditional evaluationProcedure or surgery
Traditional way of evaluation
iPhone 4SDevice
| Study group | Role | What they receive |
|---|---|---|
| The NeoHilda Point of care method | Active comparator | Evaluating baby including lactate dehydrogenase Levels measured in umbilical core blood using the fast point of care method called Neo Hilda Receives: Device: The Neo Hilda; Device: iPhone 4S |
| No Measurement of LDH | Sham comparator | Evaluating baby without Lactate dehydrogenase result Receives: Procedure: Traditional evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients admitted to correct level of care, NICU or level 2 unit, in the two groups the admitting doctor has or has not access to plasma LDH respectively.
The definitions of correct or not correct admission level were:
- Admitted to NICU care: correct decision=The patient did fulfil the criteria for referral to NICU during the first 80 and 96 hours after admission.
- Admitted to NICU care: not correct decision=The patient did not fulfil the criteria for referral to NICU during the first 80 to 96 hours after admission.
- Admitted to level 2 unit: correct decision=The patient did not fulfil the criteria for referral to NICU during the first 80 to 96 hours after admission.
- Admitted to level 2 unit: not correct decision= The patient did fulfil the criteria for referral to NICU between 80 and 96 hours after admission
Measured: at 96 hours after admission
Secondary outcomes (1)
The proportion of admitted infants diagnosed as HIE had an LDH value according to the Hilda Card over cut off 600 U/l.
Measured: 30 days after completion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startAug 2013
- Primary completionNov 2013
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for NeonatalStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Children's Hospital, Vietnam
- Sponsor type
- University, hospital or other
- Collaborators
- Calmark Sweden AB, Karolinska Institutet
- Responsible party
- Principal investigator, Khu Khanh Thi, Dung, National Children's Hospital, Vietnam
- Investigators
- Khu TK Dung, Ass prof., Principal investigator, National Hospital of PediatricsBirger Winbladh, Professor, Study director, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02379936
- Sponsor's protocol ID
- HildaNeo test study Vietnam
- Acronym
- HildaNeoHan
- Status last verified
- Feb 2015
- First submitted
- 20 Aug 2013
- Last updated
- 5 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Karlsson M, Dung KT, Thi TL, Borgstrom E, Jonstam K, Kasstrom L, Winbladh B. Lactate dehydrogenase as an indicator of severe illness in neonatal intensive care patients: a longitudinal cohort study. Acta Paediatr. 2012 Dec;101(12):1225-31. doi: 10.1111/apa.12014.
PubMed 22963670Karlsson M, Wiberg-Itzel E, Chakkarapani E, Blennow M, Winbladh B, Thoresen M. Lactate dehydrogenase predicts hypoxic ischaemic encephalopathy in newborn infants: a preliminary study. Acta Paediatr. 2010 Aug;99(8):1139-44. doi: 10.1111/j.1651-2227.2010.01802.x. Epub 2010 Mar 19.
PubMed 20236255Wiberg-Itzel E, Akerud H, Andolf E, Hellstrom-Westas L, Winbladh B, Wennerholm UB. Association between adverse neonatal outcome and lactate concentration in amniotic fluid. Obstet Gynecol. 2011 Jul;118(1):135-142. doi: 10.1097/AOG.0b013e318220c0d4.
PubMed 21691171Thoresen M, Liu X, Jary S, Brown E, Sabir H, Stone J, Cowan F, Karlsson M. Lactate dehydrogenase in hypothermia-treated newborn infants with hypoxic-ischaemic encephalopathy. Acta Paediatr. 2012 Oct;101(10):1038-44. doi: 10.1111/j.1651-2227.2012.02778.x. Epub 2012 Jul 27.
PubMed 22775455
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Point of Care Analyzer for Lactate Dehydrogenase, HildaNeo, as Support for Decisions When Admitting Newborn to the Neonatal Wards at NPH
- ClinicalTrials.gov ID
- NCT02379936
- Acronym / sponsor ID
- HildaNeoHan / HildaNeo test study Vietnam
- Keywords
- Classification, HIE, Infections, Lactate dehydrogenase, Intensive Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- National Children's Hospital, VietnamUniversity, hospital or other
- Collaborators
- Calmark Sweden AB, Karolinska Institutet
- Study start
- Aug 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 5 Mar 2015 (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 immediate newborn period is the period of highest morbidity in life. Early signs of serious disease are often vague and difficult to interpret for the non- specialist. Screening lists of clinical signs are useful but have unsatisfactory specificity or sensitivity, cover only one or two diseases, and are complicated to handle in low resource settings.
In critically ill newborns, organ failure to one or multiple organ systems is frequently seen due to inadequate circulation to the tissues. Critical disease will cause hypoxia ischemia of the cells in the affected organs followed by energy deficiency. Independently of the condition causing the energy deficiency this will start a series of events, which initially cause a leaking cell membrane leading to that intracellular components, i.e. the enzyme Lactate dehydrogenase (LDH), will leak out into the blood. Previous research in newborns suggests that LDH is a clinically interesting early predictor of serious illness and may thus serve as an important complement to the clinical examination. If the LDH level is elevated the health care personnel will realize that something is wrong and call for appropriate measures.
Today LDH analysis is performed at the Dept. of Clinical Chemistry with an inexpensive and accurate method. However, this method needs relatively large blood volumes and the delay between blood sampling and results is rather long, often several hours. In addition LDH is sensitive to hemolysis, which is quite common in blood sampling in newborns. When this is detected at the laboratory a new sample will be needed, thus delaying the result even more. Also, smaller health care facilities rarely have the laboratory equipment needed for the analysis of LDH.
The Swedish company Calmark Sweden AB is now launching a point-of-care technology for LDH analysis called "Hilda Neo". LDH is analyzed on an easy-to-use consumable test card together with an "App" on an ordinary smartphone (in the planned study, iPhone 4S). The result is presented within minutes and presence of hemolysis will be simultaneously detected on the device.
The investigators speculate that the use of such a LDH test could serve as a diagnostic help for health-care staff in Vietnam in making the decision when to send a potentially sick newborn to a higher level neonatal unit (in this case the NICU at NPH, Hanoi)
Detailed description
Patients and Methods At admission to NPH, newborn (GA >32 w, ≤36h old) infants referred to NPH with suspect or probable clinical signs of illness for which the physician on call considers that a blood sample is needed will be included in the study when a doctor taking part in the study is present at the ward. When a blood test is indicated, around 2 ml of blood is routinely drawn including an extra 0.1 ml blood for analysis of LDH using the Hilda Neo card.
When an infant fulfils the inclusion criteria the physician on duty will open a downloaded "App" on the provided smartphone and take a photo of the first page of the study protocol including the patients study number time of birth, and the result of the clinical investigation on a simple clinical score protocol. Then the physician presses a "randomise button" on the smartphone to randomise to using the Hilda Neo card or to routine care. If randomised to the Hilda Neo card use the "app" gives instructions how to use the card and guides through the different steps of the test. The result of the LDH test will be presented to the physician immediately at the point-of-care and can be used in the clinical decisions.
To prepare for a following study of the usefulness of LDH when deciding if a baby is ready for transfer from the NICU to ordinary care all included infants will have an LDH test at the routine clinical laboratory daily when other blood samples are drawn. The investigators believe that two LDH tests at 6 - 24 hour intervals are needed for that question. The reason for using two tests with an interval is that a high single LDH value can be expected in a large number of the infants because of the preceding disease while a decreasing value might be a better predictor of an improving status.
An evaluation protocol is filled in by the neonatologist in the ward 80-96h after admission or, if earlier, at discharge or death. The classification of the protocols into "need for" and "no need for intensive care resources" will be done independently by two senior neonatologists, both blinded to the LDH results from the Hilda card and the routine clinical laboratory.
The outcome that will be reported is the number of patients admitted to correct level of care, NICU or level 2 unit, in the two groups the admitting doctor has or has not access to plasma LDH respectively.
The definitions of correct or not correct admission level were:
- Admitted to NICU care: correct decision=The patient did fulfil the criteria for referral to NICU during the first 80 and 96h after admission.
- Admitted to NICU care: not correct decision=The patient did not fulfil the criteria for referral to NICU during the first 80 to 96h after admission.
- Admitted to level 2 unit: correct decision=The patient did not fulfil the criteria for referral to NICU during the first 80 to 96h after admission.
- Admitted to level 2 unit: not correct decision= The patient did fulfil the criteria for referral to NICU between 80 and 96h after admission The classification of the protocols into "fulfil or not fulfil the criteria for intensive care resources" was done independently by two senior neonatologists, both blinded to the LDH results from the Hilda card and the routine clinical laboratory.
The criteria for "fulfil the criteria for intensive care resources" were that shock-, ventilator-, CPAP- treatment, blood exchange, parenteral nutrition or other procedures demanding NICU capacity in the actual setting were performed during the first 80 - 96 hours after admission.
For calculation of the number of patients needed for the study outcome "right decision" in relation to "wrong decision" will be used, see below under Power.
The results will be recorded on the paper protocol forms, which are kept with the clinical record of the patient. The results will also be kept as a photo using the Smart phone App where it can be read only until the picture has been sent to the register. When the picture comes to the register it is identified only by its study number. Name and identity together with the study number is taken from the patient record to a separate register, which is securely kept by one authorized person in order for future supplementary information. The data recorded for the study are those normally recorded for a NICU patient and the doctors evaluation of the Hilda card.
The de-identified protocols will be saved, processed and analysed with the statistical program SPSS. Only persons involved in the study will have access to the data registered.
Based on going (Itzel et.al) and previously conducted research a LDH activity exceeding 600U/L will be considered as increased.
Power calculation In the investigators earlier study about 75% of the babies admitted to the NICU did not need intensive care procedures during the first week. To detect a reduction from 75 to 50% according to outcome above would need 58 patients in the test and the control group respectively. The control group here is the group that is not admitted to the NICU ward but to the ordinary care ward.
If there are technical or other problems with the Hilda Neo test that might influence the primary outcome the study will include 58 babies after the problem has been solved.
The background factors and the criteria for need of intensive care that will be noted are presented on the protocols, (n= 120+20 patients)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The NeoHilda Point of care method | Active comparator | Device: The Neo Hilda, Device: iPhone 4SEvaluating baby including lactate dehydrogenase Levels measured in umbilical core blood using the fast point of care method called Neo Hilda |
| No Measurement of LDH | Sham comparator | Procedure: Traditional evaluationEvaluating baby without Lactate dehydrogenase result |
Who may qualify
- Ages
- 2 minutes to 36 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children admitted to the neonatal ward above 32w of age, considered for blood sampling.
Key exclusion criteria (2 listed)
- Parental consent missing
- Gestational age less than 33 weeks postnatal age above 36 hours
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 |
|---|---|---|
| The Neo HildaAlso: Neo Hilda, Calmark Sweden ABThis is a procedure that measures Lactate dehydrogenase in a fast and reliable way from only 10 microliter of blood. Using a small point of care card and a Smartphone for analysis. Point of care method | Device | The NeoHilda Point of care method |
| Traditional evaluationTraditional way of evaluation | Procedure or surgery | No Measurement of LDH |
| iPhone 4S | Device | The NeoHilda Point of care method |
Primary outcome
The number of patients admitted to correct level of care, NICU or level 2 unit, in the two groups the admitting doctor has or has not access to plasma LDH respectively.
Time frame: at 96 hours after admission
The definitions of correct or not correct admission level were: 1. Admitted to NICU care: correct decision=The patient did fulfil the criteria for referral to NICU during the first 80 and 96 hours after admission. 2. Admitted to NICU care: not correct decision=The patient did not fulfil the criteria for referral to NICU during the first 80 to 96 hours after admission. 3. Admitted to level 2 unit: correct decision=The patient did not fulfil the criteria for referral to NICU during the first 80 to 96 hours after admission. 4. Admitted to level 2 unit: not correct decision= The patient did fulfil the criteria for referral to NICU between 80 and 96 hours after admission
1 secondary outcome
The proportion of admitted infants diagnosed as HIE had an LDH value according to the Hilda Card over cut off 600 U/l.
Time frame: 30 days after completion of study
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 Mar 2015.
- Background: PubMed 22963670Karlsson M, Dung KT, Thi TL, Borgstrom E, Jonstam K, Kasstrom L, Winbladh B. Lactate dehydrogenase as an indicator of severe illness in neonatal intensive care patients: a longitudinal cohort study. Acta Paediatr. 2012 Dec;101(12):1225-31. doi: 10.1111/apa.12014.
- Background: PubMed 20236255Karlsson M, Wiberg-Itzel E, Chakkarapani E, Blennow M, Winbladh B, Thoresen M. Lactate dehydrogenase predicts hypoxic ischaemic encephalopathy in newborn infants: a preliminary study. Acta Paediatr. 2010 Aug;99(8):1139-44. doi: 10.1111/j.1651-2227.2010.01802.x. Epub 2010 Mar 19.
- Background: PubMed 21691171Wiberg-Itzel E, Akerud H, Andolf E, Hellstrom-Westas L, Winbladh B, Wennerholm UB. Association between adverse neonatal outcome and lactate concentration in amniotic fluid. Obstet Gynecol. 2011 Jul;118(1):135-142. doi: 10.1097/AOG.0b013e318220c0d4.
- Background: PubMed 22775455Thoresen M, Liu X, Jary S, Brown E, Sabir H, Stone J, Cowan F, Karlsson M. Lactate dehydrogenase in hypothermia-treated newborn infants with hypoxic-ischaemic encephalopathy. Acta Paediatr. 2012 Oct;101(10):1038-44. doi: 10.1111/j.1651-2227.2012.02778.x. Epub 2012 Jul 27.
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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.
Khu TK Dung, Ass prof. principal investigator
National Hospital of Pediatrics
Birger Winbladh, Professor study director
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Neo Hilda, Traditional evaluation and iPhone 4S in people with Neonatal and Asphyxia, run by National Children's Hospital, Vietnam at 1 site in Vietnam.
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 1 inclusion and 2 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 Mar 2015. 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 Vietnam. 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. Some participants in this study may receive a placebo. 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?
The number of patients admitted to correct level of care, NICU or level 2 unit, in the two groups the admitting doctor has or has not access to plasma LDH respectively. (time frame: at 96 hours after admission). 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 NCT02379936, which also lists 4 linked publications.
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 Mar 2015.