Evaluation of Haemodynamic in Neonates Treated With Hypothermia"

NCT05574855 | Completed

• 1 other identifier: 0048225966136
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 4

Brief 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. 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

Conditions

Haemodynamic Instability; Perinatal Asphyxia; Hypothermia Neonatal

Keywords

Echocardiography; Neonate; Perinatal asphyxia; Therapeutic hypothermia

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (10)

• Assessment of the influence of TH on the cerebral circulation in comparison with the control group in arterior cerebral artery

  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

  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

  until 7 day after birth

• Assessment of the influence of TH on the visceral circulation in comparison with the control group

  until 7 day after birth

• Assessment of the influence of TH on the renal circulation in comparison with the control group

  until 7 day after birth

Study Arms (2)

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)

Eligibility Criteria

• Age: Up to 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Congenital cardiac abnormalities
• Genetic abnormalities
• Absence of parental or guardian consent for participation in the study
• SGA \<10 centiles

Sponsors & Collaborators

• Princess Anna Mazowiecka Hospital, Warsaw, Poland: lead

Study Sites (4)

Department of Neonatology and Neonatal Intensive Care Warsaw Medical University

Warsaw, 00-315, Poland

Location

Princess Anna Mazowiecka Hospital

Warsaw, 00-315, Poland

Location

Centrum Medyczne "ŻELAZNA"

Warsaw, 01-004, Poland

Location

Lazarski University Faculty of Medicine

Warsaw, Poland

Location

Related Publications (5)

• 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.

  PMID: 28573895 BACKGROUND

• 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.

  PMID: 29571928 BACKGROUND

• 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.

  PMID: 30814366 BACKGROUND

• 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.

  PMID: 31676739 BACKGROUND

• Brunets 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.

  PMID: 37144150 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Clinical Professor, Head of Department of Neonatology

Study Record Dates

• First Submitted: September 30, 2022
• First Posted: October 12, 2022
• Study Start: August 1, 2021
• Primary Completion: February 16, 2024
• Study Completion: February 16, 2024
• Last Updated: December 3, 2025

Record last verified: 2025-11

Locations

PL (4)