Hypothermia NeonatalNCT05574855
Evaluation of Haemodynamic in Neonates Treated With Hypothermia"
An observational study of Hypothermia Neonatal and Haemodynamic Instability, run by Princess Anna Mazowiecka Hospital, Warsaw, Poland at 4 sites in Poland.
Trial summary
Perinatal hypoxia in the form of hypoxic-ischaemic encephalopathy (HIE) is a frequent cause of cerebral impairment in neonates. HIE occurs in 3 to 5 of 1000 neonates in developed countries and is significantly higher in developing countries at 25 of 1000 neonates. Read more about this study
- Who is it for?
- Ages Up to 7 days
- Conditions the study is for
- Hypothermia Neonatal, Haemodynamic Instability, Perinatal Asphyxia
- How many people
- 113 participants
- Where
- 4 sitesPoland
- Study dates
- 1 Aug 2021to 16 Feb 2024
- How long will I take part?
- 2 Months
- 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 7 days
- All sexes
- No healthy volunteers
- Child
Study population: This is a multicentre, prospective, case-control, observational study. The number of subjects under observation will be 113 neonates. The enrolment, intervention and assessment schedule is presented in tabel. Initial echocardiography and cerebral and abdominal ultrasonography will be conducted according to physician recommendation by two neonatologist. The study procedure will be explained to patient's guardians who will also receive an information leaflet. Guardians will then be asked to provide two copies of informed consent.
Who may be able to join
- Neonates with gestation age ≥35, whith episode of PA and who were qualified for TH according to the Standards of Medical care of Neonates in Poland (10) was enrolled to the SG
- Healthy, neonates with gastation >37 0/7 < 41 6/7, who underwent ECHO for reasons such as difficult adaptation, gestational diabetes of the mother etc. was enrolled to the CG.
Who cannot join
- Congenital cardiac abnormalities
- Genetic abnormalities
- Absence of parental or guardian consent for participation in the study
- SGA <10 centiles
Trial locations and contacts
4 sites in 1 country.
Poland4 sites
Department of Neonatology and Neonatal Intensive Care Warsaw Medical University
Warsaw, 00-315
Princess Anna Mazowiecka Hospital
Warsaw, 00-315
Centrum Medyczne "ŻELAZNA"
Warsaw, 01-004
Lazarski University Faculty of Medicine
Warsaw
About this study
Official title: Echocardiographic and Ultrasound Evaluation of Haemodynamic Parameters in Hypoxic Neonates Treated With Hypothermia.
Perinatal hypoxia in the form of hypoxic-ischaemic encephalopathy (HIE) is a frequent cause of cerebral impairment in neonates. HIE occurs in 3 to 5 of 1000 neonates in developed countries and is significantly higher in developing countries at 25 of 1000 neonates. Despite developments in medicine, increasing understanding of HIE pathophysiology and progress in neonatal intensive care as well as treatment of moderate or severe perinatal asphyxia, HIE continues to be associated with significant mortality and late neurological sequelae.
Episodes of ischaemia-hypoxia in the perinatal period as well as the changes in the redistribution of blood may lead to decreased perfusion and ischaemia of the cardiac muscle. Additionally, there is a negative impact from the reduced contractility of the cardiac muscle secondary to acidosis and hypoxia. Therapeutic hypothermia (TH) improves the late effects in moderate and severe cases of hypoxia-ischaemia encephalopathy (HIE). The direct impact of TH on the cardiovascular system includes moderate bradycardia, increased pulmonary vascular resistance (PVR), inferior filling of the left ventricle (LV) and LV stroke volume. The above-mentioned consequences of TH and episodes of HI in the perinatal period are therefore exacerbation of respiratory and circulatory failure. The impact of the warming phase on the cardiovascular system is not well researched and currently few data has been published on this topic. Physiologically, warming increases heart rate, improves cardiac output and increases systemic pressure. The effect of TH and the warming phase on the cardiovascular values has a decisive impact on the metabolism of drugs, including vasopressors / inotropics, which in turn affects the choice of medication and fluid therapy
Read the detailed description
Impact of hypoxia on the cardiovascular system Transitory hypoxia of the myocardium (and its resultant dysfunction), which may, but not necessarily, present clinically, occurs in two thirds of neonates born with perinatal asphyxia. There is no doubt that that this is one of the more frequent cause of circulatory insufficiency. Both an episode of ischaemic hypoxia in the perinatal period and the changes in the distribution of blood may lead to diminished perfusion of the cardiac muscle. An additional but no less important impact on cardiac function is the immaturity of the neonatal myocardium and its reduced contractility secondary to acidosis and hypoxia. Ischaemia and acidosis lead to imbalance in favour of production of endothelin 1, which leads to reduced production of nitric oxide and vasoconstriction of pulmonary vessels and therefore greater pulmonary vascular resistance (PVR) which has a detrimental effect on the already impaired right ventricular (RV) function. The weak RV function and increase PVR impair filling and function of the left ventricle (LV) and thus, they can affect systemic and cerebral blood flow.
The impact of therapeutic hypothermia on the cardiovascular system
TH improves the distant results in cases of moderate and severe HIE and is currently the standard of care for neonates born at or near term (> 35 weeks of gestation). The direct effect of TH on the cardiovascular system includes the following:
- Moderate bradycardia resulting from the decreased effect of the parasympathetic system on cardiac function. Indeed, sinus bradycardia leads to reduced stroke volume and decreased requirement for energy by the myocardium. In turn, administration of inotropes increase metabolic requirements.
- Additionally, TH leads to increased PVR, potentially resulting in a clinical picture of persistent pulmonary hypertension in the neonate (PPHN) or its exacerbation in cases of pre-existing raised PVR. In animal studies, TH was associated with increased PVR, while an increased risk of PPHN with TH was not found in RCTs.
- The resulting RV dysfunction and reduced stroke capacity of the RV leads to reduced pulmonary venous return and therefore inferior filling and stroke volume of the LV. A consequence of the effects of TH mentioned above and of an episode of HI in the perinatal period is therefore exacerbation of respiratory and circulatory failure.
Impact of the warming process on the cardiovascular system following administration of hypothermia
The impact of the warming phase on the cardiovascular system has not been well documented and currently very little data was published on this topic. Physiologically warming accelerates the heartbeat and improves stroke volume, although the mean blood pressure may fall or remain unchanged as a result of lowering of the diastolic component, which in turn affects metabolism and drug clearance, including clearance of cardiovascular medications. The warming phase, following conclusion of hypothermic treatment, affects the selection of further medicinal therapy in terms of vasopressors, inotropes and of fluid therapy. Furthermore, studies have shown that neonates are more at risk of convulsive episodes during the warming phase. In a study of 160 neonates, 9% experienced intra- or periventricular haemorrhage. Neonates require more precise observation in terms of haemodynamic instability during the warming phase.
- Keywords
- Echocardiography, Neonate, Perinatal asphyxia, Therapeutic hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group I study (SG) | Neonates with gestational age ≥35, who experienced an episode of perinatal ischaemia and who were qualified for hypothermia treatment according to the Standards of Medical care of Neonates in Poland will be enrolled to the study group (SG) ( n=58) Initial echocardiography and cerebral and abdominal ultrasonography were performed at two key time points: No echo were performed on passive TH. 1. Since qualification for TH takes place up to 6 hours of life (HOL), the first examination in the SG took place between 6 and 54HOL after reaching a body temperature of 33.5°C (SG1). 2. The second examination (SG2) was performed after the TH procedure was completed and after the RW, when the body temperature reached 36.6°C, i.e., after 90HOL, but no later than 7DOL. | |
| Group II controls (CG) | Healthy term neonates who underwent ECHO due to difficult adaptation or maternal gestational diabetes were enrolled in CG1 (n=14), and those who underwent ECHO after ductus arteriosus closure or with only a trace, hemodynamically insignificant ductus, were enrolled in CG2(n=44). Initial echocardiography and cerebral and abdominal ultrasonography were performed at two key time points: 1. Health term neonates who were enrolled to the CG1 underwent ECHO at the 1/2DOL ( n=14) 2. Those who were enrolled to the CG2 underwent ECHO between 3 and 7 DOL.(n=44) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the influence of Therapeutic hypothermia (TH) on systolic-diastolic functions of the left ventricles in comparison with the control group using the Pulse Doppler
LV systolic and diastolic function on cardiac echocardiography will be assessed using the Pulse Doppler
Measured: until 7 day after birth
Assessment of the influence of Therapeutic hypothermia (TH) on systolic-diastolic functions of the right ventricles in comparison with the control group using the Pulse Doppler
RV systolic and diastolic function on cardiac echocardiography will be assessed using the Pulse Doppler
Measured: until 7 day after birth
Assessment of the influence of Therapeutic hypothermia (TH) on systolic-diastolic functions of the left ventricles in comparison with the control group using the M-mode.
LV systolic and diastolic function on cardiac echocardiography will be assessed using the M-mode.
Measured: until 7 day after birth
Assessment of the influence of Therapeutic hypothermia (TH) on systolic-diastolic functions of the right ventricles in comparison with the control group using the M-mode.
RV systolic and diastolic function on cardiac echocardiography will be assessed using the M-mode.
Measured: until 7 day after birth
Assessment of the effect of the warming phase on the systolic-diastolic functions of the left ventricles in comparison with the control group using the Tissue Doppler
LV systolic and diastolic function on cardiac echocardiography will be assessed using the Tissue Doppler
Measured: until 7 day after birth
Assessment of the effect of the warming phase on the systolic-diastolic functions of the right ventricles in comparison with the control group using the Tissue Doppler
RV systolic and diastolic function on cardiac echocardiography will be assessed using the Tissue Doppler
Measured: until 7 day after birth
Secondary outcomes (10)
Assessment of the influence of TH on the cerebral circulation in comparison with the control group in arterior cerebral artery
Controls cerebral circulation in neonates by Doppler evaluation of blood flow in anterior cerebral artery(ACA),
Measured: until 7 day after birth
Assessment of the influence of TH on the cerebral circulation in comparison with the control group in middle cerebral artery
Assessment of cerebral circulation in neonates and controls by Doppler evaluation of blood flow in middle cerebral artery (MCA),
Measured: until 7 day after birth
Assessment of the influence of TH on the cerebral circulation in comparison with the control group in the superior vena cava
Assessment of cerebral circulation in neonates and controls by Doppler evaluation of blood flow in the superior vena cava - SVC (CO)
Measured: until 7 day after birth
Assessment of the influence of TH on the visceral circulation in comparison with the control group
Assessment of visceral circulation in neonates and controls by Doppler blood flow evaluation in mesenteric artery (SMA).
Measured: until 7 day after birth
Assessment of the influence of TH on the renal circulation in comparison with the control group
Assessment of renal circulation in neonates and controls by Doppler blood flow evaluation in right renal artery (RRA).
Measured: until 7 day after birth
Assessment of the effect of the warming phase on the cerebral circulation in comparison with the control group in arterior cerebral artery
Assessment of cerebral circulation in neonates and controls by Doppler evaluation of blood flow in anterior cerebral artery (ACA)
Measured: until 7 day after birth
Assessment of the effect of the warming phase on the cerebral circulation in comparison with the control group in middle cerebral artery
Assessment of cerebral circulation in neonates and controls by Doppler evaluation of blood flow in middle cerebral artery (MCA)
Measured: until 7 day after birth
Assessment of the effect of the warming phase on the cerebral circulation in comparison with the control group in the superior vena cava
Assessment of cerebral circulation in neonates and controls by Doppler evaluation of blood flow in the superior vena cava - SVC (CO)
Measured: until 7 day after birth
Assessment of the effect of the warming phase on the visceral circulation in comparison with the control group
Assessment of visceral circulation in neonates and controls by Doppler blood flow evaluation in mesenteric artery (SMA.)
Measured: until 7 day after birth
Assessment of the effect of the warming phase on the renal circulation in comparison with the control group
Assessment of renal circulation in neonates and controls by Doppler blood flow evaluation in right renal artery (RRA.)
Measured: until 7 day after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start1 Aug 2021
- Primary completion16 Feb 2024
- Study completion16 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hypothermia 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 113 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Princess Anna Mazowiecka Hospital, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renata Bokiniec, Princess Anna Mazowiecka Hospital, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05574855
- Sponsor's protocol ID
- 0048225966136
- Status last verified
- Nov 2025
- First submitted
- 30 Sep 2022
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yoon JH, Lee EJ, Yum SK, Moon CJ, Youn YA, Kwun YJ, Lee JY, Sung IK. Impacts of therapeutic hypothermia on cardiovascular hemodynamics in newborns with hypoxic-ischemic encephalopathy: a case control study using echocardiography. J Matern Fetal Neonatal Med. 2018 Aug;31(16):2175-2182. doi: 10.1080/14767058.2017.1338256. Epub 2017 Jul 7.
PubMed 28573895Wu TW, Tamrazi B, Soleymani S, Seri I, Noori S. Hemodynamic Changes During Rewarming Phase of Whole-Body Hypothermia Therapy in Neonates with Hypoxic-Ischemic Encephalopathy. J Pediatr. 2018 Jun;197:68-74.e2. doi: 10.1016/j.jpeds.2018.01.067. Epub 2018 Mar 20.
PubMed 29571928Sehgal A, Linduska N, Huynh C. Cardiac adaptation in asphyxiated infants treated with therapeutic hypothermia. J Neonatal Perinatal Med. 2019;12(2):117-125. doi: 10.3233/NPM-1853.
PubMed 30814366Bhagat I, Sarkar S. Multiple Organ Dysfunction During Therapeutic Cooling of Asphyxiated Infants. Neoreviews. 2019 Nov;20(11):e653-e660. doi: 10.1542/neo.20-11-e653.
PubMed 31676739Brunets N, Brunets V, Bokiniec R. Echocardiographic and ultrasound evaluation of haemodynamic parameters in hypoxic neonates treated with hypothermia: Study protocol. Front Pediatr. 2023 Apr 18;11:1122738. doi: 10.3389/fped.2023.1122738. eCollection 2023.
PubMed 37144150
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiographic and Ultrasound Evaluation of Haemodynamic Parameters in Hypoxic Neonates Treated With Hypothermia.
- ClinicalTrials.gov ID
- NCT05574855
- Acronym / sponsor ID
- 0048225966136
- Keywords
- Echocardiography, Neonate, Perinatal asphyxia, Therapeutic hypothermia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Princess Anna Mazowiecka Hospital, Warsaw, PolandUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 16 Feb 2024 (actual)
- Study completion
- 16 Feb 2024 (actual)
- First posted
- 12 Oct 2022 (actual)
- 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.
Perinatal hypoxia in the form of hypoxic-ischaemic encephalopathy (HIE) is a frequent cause of cerebral impairment in neonates. HIE occurs in 3 to 5 of 1000 neonates in developed countries and is significantly higher in developing countries at 25 of 1000 neonates. Despite developments in medicine, increasing understanding of HIE pathophysiology and progress in neonatal intensive care as well as treatment of moderate or severe perinatal asphyxia, HIE continues to be associated with significant mortality and late neurological sequelae.
Episodes of ischaemia-hypoxia in the perinatal period as well as the changes in the redistribution of blood may lead to decreased perfusion and ischaemia of the cardiac muscle. Additionally, there is a negative impact from the reduced contractility of the cardiac muscle secondary to acidosis and hypoxia. Therapeutic hypothermia (TH) improves the late effects in moderate and severe cases of hypoxia-ischaemia encephalopathy (HIE). The direct impact of TH on the cardiovascular system includes moderate bradycardia, increased pulmonary vascular resistance (PVR), inferior filling of the left ventricle (LV) and LV stroke volume. The above-mentioned consequences of TH and episodes of HI in the perinatal period are therefore exacerbation of respiratory and circulatory failure. The impact of the warming phase on the cardiovascular system is not well researched and currently few data has been published on this topic. Physiologically, warming increases heart rate, improves cardiac output and increases systemic pressure. The effect of TH and the warming phase on the cardiovascular values has a decisive impact on the metabolism of drugs, including vasopressors / inotropics, which in turn affects the choice of medication and fluid therapy
Detailed description
Impact of hypoxia on the cardiovascular system Transitory hypoxia of the myocardium (and its resultant dysfunction), which may, but not necessarily, present clinically, occurs in two thirds of neonates born with perinatal asphyxia. There is no doubt that that this is one of the more frequent cause of circulatory insufficiency. Both an episode of ischaemic hypoxia in the perinatal period and the changes in the distribution of blood may lead to diminished perfusion of the cardiac muscle. An additional but no less important impact on cardiac function is the immaturity of the neonatal myocardium and its reduced contractility secondary to acidosis and hypoxia. Ischaemia and acidosis lead to imbalance in favour of production of endothelin 1, which leads to reduced production of nitric oxide and vasoconstriction of pulmonary vessels and therefore greater pulmonary vascular resistance (PVR) which has a detrimental effect on the already impaired right ventricular (RV) function. The weak RV function and increase PVR impair filling and function of the left ventricle (LV) and thus, they can affect systemic and cerebral blood flow.
The impact of therapeutic hypothermia on the cardiovascular system
TH improves the distant results in cases of moderate and severe HIE and is currently the standard of care for neonates born at or near term (> 35 weeks of gestation). The direct effect of TH on the cardiovascular system includes the following:
- Moderate bradycardia resulting from the decreased effect of the parasympathetic system on cardiac function. Indeed, sinus bradycardia leads to reduced stroke volume and decreased requirement for energy by the myocardium. In turn, administration of inotropes increase metabolic requirements.
- Additionally, TH leads to increased PVR, potentially resulting in a clinical picture of persistent pulmonary hypertension in the neonate (PPHN) or its exacerbation in cases of pre-existing raised PVR. In animal studies, TH was associated with increased PVR, while an increased risk of PPHN with TH was not found in RCTs.
- The resulting RV dysfunction and reduced stroke capacity of the RV leads to reduced pulmonary venous return and therefore inferior filling and stroke volume of the LV. A consequence of the effects of TH mentioned above and of an episode of HI in the perinatal period is therefore exacerbation of respiratory and circulatory failure.
Impact of the warming process on the cardiovascular system following administration of hypothermia
The impact of the warming phase on the cardiovascular system has not been well documented and currently very little data was published on this topic. Physiologically warming accelerates the heartbeat and improves stroke volume, although the mean blood pressure may fall or remain unchanged as a result of lowering of the diastolic component, which in turn affects metabolism and drug clearance, including clearance of cardiovascular medications. The warming phase, following conclusion of hypothermic treatment, affects the selection of further medicinal therapy in terms of vasopressors, inotropes and of fluid therapy. Furthermore, studies have shown that neonates are more at risk of convulsive episodes during the warming phase. In a study of 160 neonates, 9% experienced intra- or periventricular haemorrhage. Neonates require more precise observation in terms of haemodynamic instability during the warming phase.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I study (SG) | – | –Neonates with gestational age ≥35, who experienced an episode of perinatal ischaemia and who were qualified for hypothermia treatment according to the Standards of Medical care of Neonates in Poland will be enrolled to the study group (SG) ( n=58) Initial echocardiography and cerebral and abdominal ultrasonography were performed at two key time points: No echo were performed on passive TH. 1. Since qualification for TH takes place up to 6 hours of life (HOL), the first examination in the SG took place between 6 and 54HOL after reaching a body temperature of 33.5°C (SG1). 2. The second examination (SG2) was performed after the TH procedure was completed and after the RW, when the body temperature reached 36.6°C, i.e., after 90HOL, but no later than 7DOL. |
| Group II controls (CG) | – | –Healthy term neonates who underwent ECHO due to difficult adaptation or maternal gestational diabetes were enrolled in CG1 (n=14), and those who underwent ECHO after ductus arteriosus closure or with only a trace, hemodynamically insignificant ductus, were enrolled in CG2(n=44). Initial echocardiography and cerebral and abdominal ultrasonography were performed at two key time points: 1. Health term neonates who were enrolled to the CG1 underwent ECHO at the 1/2DOL ( n=14) 2. Those who were enrolled to the CG2 underwent ECHO between 3 and 7 DOL.(n=44) |
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This is a multicentre, prospective, case-control, observational study. The number of subjects under observation will be 113 neonates. The enrolment, intervention and assessment schedule is presented in tabel. Initial echocardiography and cerebral and abdominal ultrasonography will be conducted according to physician recommendation by two neonatologist. The study procedure will be explained to patient's guardians who will also receive an information leaflet. Guardians will then be asked to provide two copies of informed consent.
Key inclusion criteria (2 listed)
- Neonates with gestation age ≥35, whith episode of PA and who were qualified for TH according to the Standards of Medical care of Neonates in Poland (10) was enrolled to the SG
- Healthy, neonates with gastation >37 0/7 < 41 6/7, who underwent ECHO for reasons such as difficult adaptation, gestational diabetes of the mother etc. was enrolled to the CG.
Key exclusion criteria (4 listed)
- Congenital cardiac abnormalities
- Genetic abnormalities
- Absence of parental or guardian consent for participation in the study
- SGA <10 centiles
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of the influence of Therapeutic hypothermia (TH) on systolic-diastolic functions of the left ventricles in comparison with the control group using the Pulse Doppler
Time frame: until 7 day after birth
LV systolic and diastolic function on cardiac echocardiography will be assessed using the Pulse Doppler
Assessment of the influence of Therapeutic hypothermia (TH) on systolic-diastolic functions of the right ventricles in comparison with the control group using the Pulse Doppler
Time frame: until 7 day after birth
RV systolic and diastolic function on cardiac echocardiography will be assessed using the Pulse Doppler
Assessment of the influence of Therapeutic hypothermia (TH) on systolic-diastolic functions of the left ventricles in comparison with the control group using the M-mode.
Time frame: until 7 day after birth
LV systolic and diastolic function on cardiac echocardiography will be assessed using the M-mode.
Assessment of the influence of Therapeutic hypothermia (TH) on systolic-diastolic functions of the right ventricles in comparison with the control group using the M-mode.
Time frame: until 7 day after birth
RV systolic and diastolic function on cardiac echocardiography will be assessed using the M-mode.
Assessment of the effect of the warming phase on the systolic-diastolic functions of the left ventricles in comparison with the control group using the Tissue Doppler
Time frame: until 7 day after birth
LV systolic and diastolic function on cardiac echocardiography will be assessed using the Tissue Doppler
Assessment of the effect of the warming phase on the systolic-diastolic functions of the right ventricles in comparison with the control group using the Tissue Doppler
Time frame: until 7 day after birth
RV systolic and diastolic function on cardiac echocardiography will be assessed using the Tissue Doppler
10 secondary outcomes
Assessment of the influence of TH on the cerebral circulation in comparison with the control group in arterior cerebral artery
Time frame: until 7 day after birth
Assessment of the influence of TH on the cerebral circulation in comparison with the control group in middle cerebral artery
Time frame: until 7 day after birth
Assessment of the influence of TH on the cerebral circulation in comparison with the control group in the superior vena cava
Time frame: until 7 day after birth
Assessment of the influence of TH on the visceral circulation in comparison with the control group
Time frame: until 7 day after birth
Assessment of the influence of TH on the renal circulation in comparison with the control group
Time frame: until 7 day after birth
Assessment of the effect of the warming phase on the cerebral circulation in comparison with the control group in arterior cerebral artery
Time frame: until 7 day after birth
Assessment of the effect of the warming phase on the cerebral circulation in comparison with the control group in middle cerebral artery
Time frame: until 7 day after birth
Assessment of the effect of the warming phase on the cerebral circulation in comparison with the control group in the superior vena cava
Time frame: until 7 day after birth
Assessment of the effect of the warming phase on the visceral circulation in comparison with the control group
Time frame: until 7 day after birth
Assessment of the effect of the warming phase on the renal circulation in comparison with the control group
Time frame: until 7 day after birth
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 3 Dec 2025.
- Background: PubMed 28573895Yoon JH, Lee EJ, Yum SK, Moon CJ, Youn YA, Kwun YJ, Lee JY, Sung IK. Impacts of therapeutic hypothermia on cardiovascular hemodynamics in newborns with hypoxic-ischemic encephalopathy: a case control study using echocardiography. J Matern Fetal Neonatal Med. 2018 Aug;31(16):2175-2182. doi: 10.1080/14767058.2017.1338256. Epub 2017 Jul 7.
- Background: PubMed 29571928Wu TW, Tamrazi B, Soleymani S, Seri I, Noori S. Hemodynamic Changes During Rewarming Phase of Whole-Body Hypothermia Therapy in Neonates with Hypoxic-Ischemic Encephalopathy. J Pediatr. 2018 Jun;197:68-74.e2. doi: 10.1016/j.jpeds.2018.01.067. Epub 2018 Mar 20.
- Background: PubMed 30814366Sehgal A, Linduska N, Huynh C. Cardiac adaptation in asphyxiated infants treated with therapeutic hypothermia. J Neonatal Perinatal Med. 2019;12(2):117-125. doi: 10.3233/NPM-1853.
- Background: PubMed 31676739Bhagat I, Sarkar S. Multiple Organ Dysfunction During Therapeutic Cooling of Asphyxiated Infants. Neoreviews. 2019 Nov;20(11):e653-e660. doi: 10.1542/neo.20-11-e653.
- Derived from this study: PubMed 37144150Brunets N, Brunets V, Bokiniec R. Echocardiographic and ultrasound evaluation of haemodynamic parameters in hypoxic neonates treated with hypothermia: Study protocol. Front Pediatr. 2023 Apr 18;11:1122738. doi: 10.3389/fped.2023.1122738. eCollection 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothermia Neonatal and Haemodynamic Instability, run by Princess Anna Mazowiecka Hospital, Warsaw, Poland at 4 sites in Poland.
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 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: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Poland. 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?
Assessment of the influence of Therapeutic hypothermia (TH) on systolic-diastolic functions of the left ventricles in comparison with the control group using the Pulse Doppler (time frame: until 7 day after birth). The study lists 6 primary outcomes in all. 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 NCT05574855, which also lists 5 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 3 Dec 2025.