NCT07427342

Brief Summary

This study aims to evaluate cerebral blood flow in stable term and preterm newborns using Doppler ultrasonography. By measuring and comparing PSV, EDV, RI, and PI in the main brain arteries, the study seeks to identify normal physiological differences in cerebral perfusion across different gestational ages. The main goal is to establish reference values that can guide clinical monitoring, allow early detection of blood flow problems, and improve neuroprotective care in newborns.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Apr 2026Dec 2027

First Submitted

Initial submission to the registry

February 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 15, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2027

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2027

Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

1 year

First QC Date

February 17, 2026

Last Update Submit

February 17, 2026

Conditions

Cerebral Blood Flow

Keywords

Cerebral Blood FlowDoppler UltrasonographyTerm and Preterm Neonates

Outcome Measures

Primary Outcomes (4)

  • Resistive Index (RI)

    RI = (PSV - EDV)/PSV, indicates downstream resistance and the flexibility of cerebral vessels

    Baseline

  • Pulsatility Index (PI)

    quantifies the shape of the blood flow waveform, reflecting how much the flow changes throughout the cardiac cycle.

    Baseline

  • Peak Systolic Velocity (PSV)

    represents blood flow during systole and reflects cardiac output

    Baseline

  • End-Diastolic Velocity (EDV)

    EDV reflects diastolic flow and the resistance in the vessels

    Baseline

Study Arms (2)

Term Neonates

Normal Term neonates ≥ 37 weeks of gestational age

Preterm Neonates

Normal Preterm neonates \< 37 weeks' gestational age

Eligibility Criteria

Age1 Hour - 48 Hours
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Term and Preterm Neonates

You may qualify if:

  • Term neonates ≥ 37 weeks of gestational age.
  • Preterm neonates \< 37 weeks' gestational age.
  • Hemodynamically stable infants at the time of examination.
  • Parental/guardian informed consent obtained.
  • Within the first 48 hours after birth.
  • Birth weight appreciate for gestational age.

You may not qualify if:

  • Infants aged more than 48 hours after birth.
  • Neonates with major congenital anomalies (cardiac, neurological, or craniofacial).
  • Suspected or confirmed intracranial hemorrhage or brain malformations, such as intraventricular hemorrhage, may influence RI measurements and interfere with accurate assessment of cerebral blood flow.
  • Neonates requiring inotropic support at the time of scan.
  • Neonates with severe respiratory instability or mechanical ventilation (unless included intentionally).
  • Infants with sepsis or metabolic derangements affecting cerebral perfusion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, Egypt

Location

Related Publications (13)

  • M. F. A. Ali, "Transcranial Doppler ultrasonography ( uses , limitations , and potentials ): a review article," 2021.

    BACKGROUND

  • M. Ramadan, E. Kholy, and I. M. A. El-dayem, "Neonatal Hypoxic Ischemic Encephalopathy : Early Diagnosis and Outcome Prediction with Ultrasound," vol. 101, no. April 2024, pp. 5520-5526, 2025.

    BACKGROUND

  • Camfferman FA, de Goederen R, Govaert P, Dudink J, van Bel F, Pellicer A, Cools F; eurUS.brain group. Diagnostic and predictive value of Doppler ultrasound for evaluation of the brain circulation in preterm infants: a systematic review. Pediatr Res. 2020 Mar;87(Suppl 1):50-58. doi: 10.1038/s41390-020-0777-x.

    PMID: 32218536BACKGROUND

  • Vinci F, Tiseo M, Colosimo D, Calandrino A, Ramenghi LA, Biasucci DG. Point-of-care brain ultrasound and transcranial doppler or color-coded doppler in critically ill neonates and children. Eur J Pediatr. 2024 Mar;183(3):1059-1072. doi: 10.1007/s00431-023-05388-0. Epub 2023 Dec 19.

    PMID: 38112802BACKGROUND

  • Bleton H, Perera S, Sejdic E. Cognitive tasks and cerebral blood flow through anterior cerebral arteries: a study via functional transcranial Doppler ultrasound recordings. BMC Med Imaging. 2016 Mar 12;16:22. doi: 10.1186/s12880-016-0125-0.

    PMID: 26969112BACKGROUND

  • Pan Y, Wan W, Xiang M, Guan Y. Transcranial Doppler Ultrasonography as a Diagnostic Tool for Cerebrovascular Disorders. Front Hum Neurosci. 2022 Apr 29;16:841809. doi: 10.3389/fnhum.2022.841809. eCollection 2022.

    PMID: 35572008BACKGROUND

  • Jarmund AH, Pedersen SA, Torp H, Dudink J, Nyrnes SA. A Scoping Review of Cerebral Doppler Arterial Waveforms in Infants. Ultrasound Med Biol. 2023 Apr;49(4):919-936. doi: 10.1016/j.ultrasmedbio.2022.12.007. Epub 2023 Jan 31.

    PMID: 36732150BACKGROUND

  • Rasulo FA, De Peri E, Lavinio A. Transcranial Doppler ultrasonography in intensive care. Eur J Anaesthesiol Suppl. 2008;42:167-73. doi: 10.1017/S0265021507003341.

    PMID: 18289437BACKGROUND

  • Naqvi J, Yap KH, Ahmad G, Ghosh J. Transcranial Doppler ultrasound: a review of the physical principles and major applications in critical care. Int J Vasc Med. 2013;2013:629378. doi: 10.1155/2013/629378. Epub 2013 Dec 12.

    PMID: 24455270BACKGROUND

  • Fichera G, Stramare R, Bisogno G, Wyttenbach R, Goeggel BS, Del Grande F, Giraudo C, Lacalamita MC. Neonatal cerebral ultrasound: anatomical variants and age-related diseases. J Ultrasound. 2024 Dec;27(4):993-1002. doi: 10.1007/s40477-024-00914-8. Epub 2024 Jun 25.

    PMID: 38918318BACKGROUND

  • Lu Q, Lu YJ, Chen ZH, Cao CY, Wu W. Predictive value of transcranial Doppler ultrasound for brain development and craniocerebral injury in premature infants. Am J Transl Res. 2025 Mar 15;17(3):2076-2082. doi: 10.62347/QJZN6645. eCollection 2025.

    PMID: 40225994BACKGROUND

  • Farag MM, Gouda MH, Almohsen AMA, Khalifa MA. Intraventricular hemorrhage prediction in premature neonates in the era of hemodynamics monitoring: a prospective cohort study. Eur J Pediatr. 2022 Dec;181(12):4067-4077. doi: 10.1007/s00431-022-04630-5. Epub 2022 Sep 28.

    PMID: 36171508BACKGROUND

  • Kamel SM, Badr-Eldin RM, Arafat MM, Hashem RH. Role of transcranial Doppler in assessment of cerebral blood flow in full term neonates with extreme unconjugated hyperbilirubinemia. J Ultrasound. 2023 Mar;26(1):175-184. doi: 10.1007/s40477-022-00704-0. Epub 2022 Aug 15.

    PMID: 35969370BACKGROUND

Study Officials

  • Hisham Mostafa Kamel, Professor

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Sawsan Samy Aly Aly

CONTACT

01159860374Sawsan.15235540@med.aun.edu.eg

Mostafa Ahmed Sayed, Lecturer

CONTACT

most.rad@aun.edu.eg

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

February 17, 2026

First Posted

February 23, 2026

Study Start

April 15, 2026

Primary Completion (Estimated)

April 15, 2027

Study Completion (Estimated)

December 15, 2027

Last Updated

February 23, 2026

Record last verified: 2026-02

Locations

EG(1)