Complications of Exchange Transfusion in Neonates

Kernicterus Clinical Trial

— COET  

Official title:

Complications of Exchange Transfusion in Neonates

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03195049
• Other study ID #: COET
• Status: Not yet recruiting
• Phase: N/A
• First received: June 15, 2017
• Last updated: June 21, 2017
• Start date: April 15, 2018
• Est. completion date: September 15, 2019

Study information

• Verified date: June 2017
• Source: Assiut University
• Contact: Hanaa Ab Mohamed, Professor
• Phone: 00201120096055
• Email: hae50[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 15, 2019
• Est. primary completion date: April 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 4 Weeks

Eligibility

Inclusion Criteria:

• All preterm and full term neonates who need exchange transfusion

Exclusion Criteria:

• Neonatal sepsis

• Congenital anomalies

Related Conditions & MeSH terms

• Kernicterus

Intervention

Diagnostic Test:
• blood group,complete blood count
measure levels of total and direct bilirubin before, during and after the procedure of exchange transfusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

Bhutani VK, Johnson LH, Keren R. Diagnosis and management of hyperbilirubinemia in the term neonate: for a safer first week. Pediatr Clin North Am. 2004 Aug;51(4):843-61, vii. Review. — View Citation

Steiner LA, Bizzarro MJ, Ehrenkranz RA, Gallagher PG. A decline in the frequency of neonatal exchange transfusions and its effect on exchange-related morbidity and mortality. Pediatrics. 2007 Jul;120(1):27-32. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum bilirubin estimation	estimation of serum bilirubin	2 days