Cord Blood S100B Protein Levels in Neonates Following Intrauterine Transfusions for HDFN-Associated Fetal Anemia

RecruitingOBSERVATIONAL
Enrollment

180

Participants

Timeline

Start Date

July 17, 2024

Primary Completion Date

January 31, 2026

Study Completion Date

April 30, 2026

Conditions
s100bHypoxia-Ischemia, BrainHemolytic Disease of the Fetus and NewbornFetal Anemia
Interventions
DIAGNOSTIC_TEST

Cord blood S100B protein level prior to IUT

One milliliter of cord blood will be collected before each IUT procedure to measure S100B protein concentration. The sample will be labeled with the mother's name, date of birth, collection date, and IUT indication, then sent to the laboratory for centrifugation.

DIAGNOSTIC_TEST

Umbilical cord blood gas analysis prior to IUT

Half a milliliter of cord blood will be collected before each IUT procedure for immediate umbilical cord blood gas analysis, including pH, base excess (BE), and lactate levels.

DIAGNOSTIC_TEST

Fetal blood count evaluation prior to IUT

Fetal blood count data, including hemoglobin and hematocrit levels, will be collected before each IUT procedure.

DIAGNOSTIC_TEST

Cord blood S100B protein concentration at birth

After delivery, one milliliter of blood will be collected from the severed umbilical cord to measure the concentration of S100B protein. The sample will be labeled with the mother's name, the child's birth date and sex, and the collection date, before being sent to the laboratory for centrifugation.

DIAGNOSTIC_TEST

Umbilical cord blood gas analysis at birth

After birth, 0.5 mL of blood will be collected from the severed umbilical cord to assess pH, base excess (BE), and lactate levels in an umbilical cord blood gas analysis.

DIAGNOSTIC_TEST

Complete blood count after birth

Complete blood count parameters, including hematocrit (Hct) and hemoglobin (Hgb) concentrations, will be measured within six hours after birth.

DIAGNOSTIC_TEST

Ultrasound evaluation of fetal blood flow

Fetal cerebral blood flow will be routinely assessed via ultrasound, including measurements of MCA-PSV values.

DIAGNOSTIC_TEST

Neonatal transfontanelle ultrasound assessment

A transfontanelle ultrasound examination will. be performed to assess for any abnormalities in the newborn.

DIAGNOSTIC_TEST

Complete blood count analysis in cord blood at birth

Complete blood count parameters, including hematocrit (Hct) and hemoglobin (Hgb) concentrations, will be measured in cord blood samples collected at birth.

Trial Locations (1)

01-211

RECRUITING

Institute of Mother and Child, Warsaw

All Listed Sponsors
lead

Institute of Mother and Child, Warsaw, Poland

OTHER