Complications of Exchange Transfusion in Neonates (COET)

• ClinicalTrials.gov Identifier: NCT03195049
• Recruitment Status: Unknown
• First Posted: June 22, 2017
• Last Update Posted: June 22, 2017
• Sponsor: Assiut University
• Information provided by (Responsible Party): Mohamed Zanaty, Assiut University

Tracking Information

• First Submitted Date: June 15, 2017
• First Posted Date: June 22, 2017
• Last Update Posted Date: June 22, 2017
• Estimated Study Start Date: April 15, 2018
• Estimated Primary Completion Date: April 15, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 21, 2017)

serum bilirubin estimation [ Time Frame: 2 days ]

estimation of serum bilirubin

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Complications of Exchange Transfusion in Neonates
• Official Title: Complications of Exchange Transfusion in Neonates
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: 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

Other Name: measure levels of total and direct bilirubin

Study Arms

• Experimental: blood group
  blood is collected for maternal and infant blood group,complete blood count,before, during and after the procedure of exchange transfusion .
  Intervention: Diagnostic Test: blood group,complete blood count
• Experimental: serum bilirubin estimation
  estimation of serum bilirubin before, during and after the procedure of exchange transfusion .
  Intervention: Diagnostic Test: blood group,complete blood count

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: June 21, 2017): 50
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 15, 2019
• Estimated Primary Completion Date: April 15, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• All preterm and full term neonates who need exchange transfusion

Exclusion Criteria:

• Neonatal sepsis
• Congenital anomalies

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 4 Weeks (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03195049
• Other Study ID Numbers: COET
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Mohamed Zanaty, Assiut University
• Study Sponsor: Assiut University
• Collaborators: Not Provided

Investigators

• Study Chair: Hanaa Ab Mohamed, Professor; Assiut University

• PRS Account: Assiut University
• Verification Date: June 2017