Clinical trial NCT04509375: Near-Infrared Spectroscopy and Cranial Doppler in Premature Newborns With Anemia
Official title: Comparison of Results of Near-Infrared Spectroscopy and Cranial Doppler Measurements in Premature Newborns With Anemia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anemia of Prematurity
Keywords: Newborn
Anemia
Near-infrared spectroscopy
Cranial doppler ultrasonography
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-08-12
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gradual improvement in middle cerebral artery flow patterns obtained by cranial doppler ultrasound imaging
timeFrame: Cranial doppler ultrasonography measurements will be obtained immediately before and 4 hours after the trasfusions.
measure: Gradual improvement in regional cerebral oxygen saturation measures obtained by near-infrared spectroscopy (NIRS)
timeFrame: NIRS measurements will be obtained 4 hours before, 2 hours during, and 4 hours after the trasfusions.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Alper Aykanat
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Ercan Ayaz
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Nursun Özcan
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.