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Complications of Exchange Transfusion in Neonates

Complications of Exchange Transfusion in Neonates

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03195049
Acronym
COET
Enrollment
50
Registered
2017-06-22
Start date
2018-04-15
Completion date
2019-09-15
Last updated
2017-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kernicterus

Keywords

hyperbilirubinemia, kernicterus

Brief summary

Exchange transfusion is effective and considered to be safe procedure ; however, it is not without risks. Complications have been reported and mortality rates vary from 0.5 to 3.3%. therefore ,the current recommendation for performing exchange transfusion are based on balance between the risks of encephalopathy and complications related to the procedure .

Detailed description

About 60% of term and 80% of preterm infants have clinical jaundice in the first week after birth but only 2% to 16% of them develop severe hyperbilirubinemia (total serum bilirubin \> 25mg/dl) ,which is an emergency because it may cause neonatal bilirubin encephalopathy (kernicterus), which can result in death or irreversible brain damage in survivor. Exchange transfusion is the standard method of therapy for immediate treatment of severe hyperbilirubinemia and prevention of kernicterus. Although the frequency of neonatal exchange transfusion has declined markedly in the past two decades, this procedure is still performed in many countries, especially in those with a high incidence of neonatal hyperbilirubinemia. Exchange transfusion is effective and considered to be safe procedure ; however, it is not without risks. Complications have been reported and mortality rates vary from 0.5 to 3.3%. therefore,the current recommendation for performing exchange transfusion are based on balance between the risks of encephalopathy and complications related to the procedure . Most of these complications are transient, such as severe thrombocytopenia, apnea, hypocalcemia , bradycardia, and hyperkalemia and recovery is expected along with appropriate care and follow up. But serious complications and even death can occurs due to cardiovascular collapse during exchange , necrotizing enterocolitis, bacterial sepsis, and pulmonary hemorrhage that can be avoided by careful cardio-pulmonary and oxygen saturation monitoring.

Interventions

DIAGNOSTIC_TESTblood group,complete blood count

measure levels of total and direct bilirubin before, during and after the procedure of exchange transfusion

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Days to 4 Weeks
Healthy volunteers
No

Inclusion criteria

* All preterm and full term neonates who need exchange transfusion

Exclusion criteria

* Neonatal sepsis * Congenital anomalies

Design outcomes

Primary

MeasureTime frameDescription
serum bilirubin estimation2 daysestimation of serum bilirubin

Contacts

Primary ContactHanaa Ab Mohamed, Professor
hae50@hotmail.com00201120096055
Backup ContactSafwat Mo Abdel-Aziz, Lecturer
Safwatabdelaziz371@yahoo.com00201003918080

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026