Near-Infrared Spectroscopy and Cranial Doppler in Premature Newborns With Anemia

NCT04509375 | Unknown

• 1 other identifier: KA-19030
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

It is aimed in this study to examine the changes in brain blood supply and oxygenation in neonatal premature babies who have anemia and who underwent erythrocyte suspension transfusion in the light of original guidelines by means of obtaining measurements with the help of cranial doppler ultrasonography and near-infrared spectroscopy.

Conditions

Anemia of Prematurity

Keywords

Newborn; Anemia; Near-infrared spectroscopy; Cranial doppler ultrasonography

Outcome Measures

Primary Outcomes (2)

• Gradual improvement in middle cerebral artery flow patterns obtained by cranial doppler ultrasound imaging

  After a critical point, the cerebral oxygenation will be compromised due to anemia in spite of normal compensation mechanisms of cerebral vasculature. Erythrocyte suspension transfusion will help to normalize altered cerebral blood flow. It is hypothesized that these changes can be detected by cranial doppler ultrasonography as follows: Middle cerebral artery peak systolic velocity and flow volume will be increased before transfusion, possibly indicating the need of intervention. Four hours after transfusion, middle cerebral artery peak systolic velocity and flow volume will gradually fall and reach eventually a steady normal state. This in turn may also serve to better understand the effectiveness of the transfusion.

  Cranial doppler ultrasonography measurements will be obtained immediately before and 4 hours after the trasfusions.

• Gradual improvement in regional cerebral oxygen saturation measures obtained by near-infrared spectroscopy (NIRS)

  After a critical point, the cerebral oxygenation will be compromised due to anemia in spite of normal compensation mechanisms of cerebral vasculature. Erythrocyte suspension transfusion will help to normalize altered cerebral blood flow. It is hypothesized that these changes can be measured by near-infrared spectroscopy (NIRS) as follows: Regional cerebral oxygen saturations (cSO2) will be low before transfusion, possibly indicating the need of intervention. During transfusion time of 2 hours, cSO2 will rise gradually and reach eventually a steady normal state in 4 hours after transfusion. This in turn may also serve to better understand the effectiveness of the transfusion.

  NIRS measurements will be obtained 4 hours before, 2 hours during, and 4 hours after the trasfusions.

Study Arms (1)

Study Group

Premature babies in the first 28 postnatal days of life, with less than 32 gestational weeks or less than 1500 grams of birth weight, with documented anemia by current accepted transfusion guidelines of Turkish Neonatal Society

Device: Cranial Doppler Ultrasonography; Device: Near-Infrared Spectroscopy

Interventions

Cranial Doppler Ultrasonography DEVICE

Before and after the transfusions, flow measurements of middle cerebral arteries will be obtained.

Study Group

Near-Infrared Spectroscopy DEVICE

Before, during and after the transfusions, regional cerebral oxygen saturation measurements will be obtained.

Study Group

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Premature babies in the first 28 postnatal days of life, with less than 32 gestational weeks or less than 1500 grams of birth weight, with documented anemia by current accepted transfusion guidelines of Turkish Neonatal Society

You may qualify if:

• Premature babies less than 32 gestational weeks or less than 1500 grams of birth weight and Documented anemia in postnatal 28 days according to Turkish Neonatal Society guidelines

You may not qualify if:

• Babies older than postnatal 28 days Major congenital anomalies Chromosomal anomalies Inborn errors of metabolism Hypoxic ischemic encephalopathy Disseminated intravascular coagulation Unstable hemodynamic status Severe neonatal sepsis Patients who are not volunteered to participate

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• Aranha CA, Lederman HM, Segre CA. Color Doppler evaluation of the influence of type of delivery, sex, postnatal age and time post feeding on full term healthy newborns cerebral blood flow. Arq Neuropsiquiatr. 2009 Jun;67(2B):463-73. doi: 10.1590/s0004-282x2009000300017.

  PMID: 19623445 BACKGROUND

• Sood BG, McLaughlin K, Cortez J. Near-infrared spectroscopy: applications in neonates. Semin Fetal Neonatal Med. 2015 Jun;20(3):164-72. doi: 10.1016/j.siny.2015.03.008. Epub 2015 Apr 29.

  PMID: 25934116 BACKGROUND

MeSH Terms

Conditions

Anemia

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Alper Aykanat

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Ercan Ayaz

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Nursun Özcan

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hasan Tolga Çelik

CONTACT

+90 530 592 55 84; htcelik@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neonatology

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 12, 2020
• Study Start: March 14, 2019
• Primary Completion: June 23, 2021
• Study Completion: June 23, 2021
• Last Updated: August 12, 2020

Record last verified: 2020-08

Locations

TU (1)