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

NCT ID: NCT04509375

Last Updated: 2020-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-14

Study Completion Date

2021-06-23

Brief Summary

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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.

Detailed Description

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Anemia in newborn babies is defined as the mean of hemoglobin values according to postnatal age is below 2 standard deviations. Disruption in tissue perfusion and oxygenation, hyperdynamic cardiac failure, increase in need of oxygen, increase in respiratory effort, inability to be separated from mechanical ventilation, failure to thrive, paleness, increase in frequency of morbidities of prematurity (necrotizing enterocolitis, retinopathy of prematurity, intraventricular hemorrhage, etc.) may be seen as a result of progressive anemia. When critical hemoglobin values are reached in premature newborn babies with concomitant disruption of tissue oxygenation, transfusion is performed with erythrocyte suspensions. The main goal here is to correct impaired tissue oxygenation, provide perfusion in sufficient quantity, and prevent anemia-related morbidities. Although frequently applied, there is no consensus in our country and in the world regarding threshold hemoglobin values and supporting parameters for transfusions. As a result, there are no guidelines prepared for newborns based on evidence with clearly defined borders and accepted by everyone. Many countries and centers implement different transfusion protocols based on their experience. Given the risk of oxygen radical damage and associated diseases as a result of erythrocyte transfusions (infections, bone marrow suppression, necrotizing enterocolitis, retinopathy of prematurity, etc.), there is a need to develop new methods for taking and supporting transfusion decision, and to prepare more objective and more accepted guidelines. The origin of our study is the subsequent protective compensation mechanisms after deterioration in brain oxygenation due to symptomatic anemia in premature newborn babies. For these reasons, it is aimed 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

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Anemia of Prematurity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Cranial Doppler Ultrasonography

Intervention Type DEVICE

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

Near-Infrared Spectroscopy

Intervention Type DEVICE

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

Interventions

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Cranial Doppler Ultrasonography

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

Intervention Type DEVICE

Near-Infrared Spectroscopy

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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
Minimum Eligible Age

1 Day

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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H. Tolga Çelik

Associate Professor of Neonatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alper Aykanat

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Ercan Ayaz

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Nursun Özcan

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Locations

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Hacettepe University

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Hasan Tolga Çelik

Role: CONTACT

+90 530 592 55 84

Facility Contacts

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Hasan Tolga Çelik

Role: primary

+90 530 592 55 84

References

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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.

Reference Type BACKGROUND
PMID: 19623445 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25934116 (View on PubMed)

Other Identifiers

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KA-19030

Identifier Type: -

Identifier Source: org_study_id

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