Perinatal Asphyxia Clinical Trial
Official title:
Echocardiographic and Ultrasound Evaluation of Haemodynamic Parameters in Hypoxic Neonates Treated With Hypothermia.
NCT number | NCT05574855 |
Other study ID # | 0048225966136 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 1, 2021 |
Est. completion date | June 30, 2024 |
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
Status | Recruiting |
Enrollment | 100 |
Est. completion date | June 30, 2024 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 72 Hours |
Eligibility | Inclusion Criteria: - Neonates aged =35 weeks of gestation with an episode of perinatal hypoxia - Neonates eligible for hypothermia treatment according to the Standards of Medical Care for Neonates in Poland Exclusion Criteria: - Absence of parental or guardian consent for participation in the study - Congenital heart defects - Genetic defects - SGA< 10 centiles |
Country | Name | City | State |
---|---|---|---|
Poland | Centrum Medyczne "ZELAZNA" | Warsaw | |
Poland | Department of Neonatology and Neonatal Intensive Care Warsaw Medical University | Warsaw | |
Poland | Lazarski University Faculty of Medicine | Warsaw | |
Poland | Princess Anna Mazowiecka Hospital | Warsaw |
Lead Sponsor | Collaborator |
---|---|
Princess Anna Mazowiecka Hospital, Warsaw, Poland |
Poland,
Bhagat 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. Review. — View Citation
Sehgal 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. — View Citation
Wu 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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | until 7 day after birth | |
Primary | 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 | until 7 day after birth | |
Primary | 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. | until 7 day after birth | |
Primary | 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. | until 7 day after birth | |
Primary | 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 | until 7 day after birth | |
Primary | 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 | until 7 day after birth | |
Secondary | 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), | until 7 day after birth | |
Secondary | 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), | until 7 day after birth | |
Secondary | 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) | until 7 day after birth | |
Secondary | 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). | until 7 day after birth | |
Secondary | 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). | until 7 day after birth | |
Secondary | 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) | until 7 day after birth | |
Secondary | 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) | until 7 day after birth | |
Secondary | 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) | until 7 day after birth | |
Secondary | 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.) | until 7 day after birth | |
Secondary | 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.) | until 7 day after birth |
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