Anemia of PrematurityNCT04509375
Near-Infrared Spectroscopy and Cranial Doppler in Premature Newborns With Anemia
An observational study of Anemia of Prematurity, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Anemia of Prematurity
- What is being tested?
- Cranial Doppler Ultrasonography and Near-Infrared Spectroscopy
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Mar 2019to 23 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University
Ankara
Hasan Tolga Çelik, +90 530 592 55 84, htcelik@gmail.com
Alper Aykanat
About this study
Official title: Comparison of Results of Near-Infrared Spectroscopy and Cranial Doppler Measurements in Premature Newborns With Anemia
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.
Read the detailed description
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
- Anemia of Prematurity
- Being tested
- Cranial Doppler Ultrasonography, Near-Infrared Spectroscopy
- Keywords
- Newborn, Anemia, Near-infrared spectroscopy, Cranial doppler ultrasonography
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranial Doppler UltrasonographyDevice
Before and after the transfusions, flow measurements of middle cerebral arteries will be obtained.
Near-Infrared SpectroscopyDevice
Before, during and after the transfusions, regional cerebral oxygen saturation measurements will be obtained.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Cranial Doppler Ultrasonography; Device: Near-Infrared Spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: NIRS measurements will be obtained 4 hours before, 2 hours during, and 4 hours after the trasfusions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start14 Mar 2019
- Primary completion23 Jun 2021 (estimated)
- Study completion23 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anemia of PrematurityStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, H. Tolga Çelik, Hacettepe University
- Investigators
- Alper Aykanat, Principal investigator, Hacettepe UniversityErcan Ayaz, Principal investigator, Hacettepe UniversityNursun Özcan, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04509375
- Sponsor's protocol ID
- KA-19030
- Status last verified
- Aug 2020
- First submitted
- 4 Aug 2020
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 19623445Sood 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.
PubMed 25934116
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Results of Near-Infrared Spectroscopy and Cranial Doppler Measurements in Premature Newborns With Anemia
- ClinicalTrials.gov ID
- NCT04509375
- Acronym / sponsor ID
- KA-19030
- Conditions
- Anemia of Prematurity
- Keywords
- Newborn, Anemia, Near-infrared spectroscopy, Cranial doppler ultrasonography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 14 Mar 2019 (actual)
- Primary completion
- 23 Jun 2021 (estimated)
- Study completion
- 23 Jun 2021 (estimated)
- First posted
- 12 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Device: Cranial Doppler Ultrasonography, Device: Near-Infrared SpectroscopyPremature 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 |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cranial Doppler UltrasonographyBefore and after the transfusions, flow measurements of middle cerebral arteries will be obtained. | Device | Study Group |
| Near-Infrared SpectroscopyBefore, during and after the transfusions, regional cerebral oxygen saturation measurements will be obtained. | Device | Study Group |
Primary outcome
Gradual improvement in middle cerebral artery flow patterns obtained by cranial doppler ultrasound imaging
Time frame: Cranial doppler ultrasonography measurements will be obtained immediately before and 4 hours after the trasfusions.
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.
Gradual improvement in regional cerebral oxygen saturation measures obtained by near-infrared spectroscopy (NIRS)
Time frame: NIRS measurements will be obtained 4 hours before, 2 hours during, and 4 hours after the trasfusions.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Background: PubMed 19623445Aranha 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.
- Background: PubMed 25934116Sood 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alper Aykanat principal investigator
Hacettepe University
Ercan Ayaz principal investigator
Hacettepe University
Nursun Özcan principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia of Prematurity, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hasan Tolga Çelik (+90 530 592 55 84, htcelik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gradual improvement in middle cerebral artery flow patterns obtained by cranial doppler ultrasound imaging (time frame: Cranial doppler ultrasonography measurements will be obtained immediately before and 4 hours after the trasfusions.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04509375, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2020.