Complications of Exchange Transfusion in Neonates (COET)

June 21, 2017 updated by: Mohamed Zanaty, Assiut University
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 .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All preterm and full term neonates who need exchange transfusion

Exclusion Criteria:

  • Neonatal sepsis
  • Congenital anomalies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: blood group
blood is collected for maternal and infant blood group,complete blood count,before, during and after the procedure of exchange transfusion .
Diagnostic test: blood group,complete blood count
measure levels of total and direct bilirubin before, during and after the procedure of exchange transfusion
Other Names:
  • measure levels of total and direct bilirubin
Experimental: serum bilirubin estimation
estimation of serum bilirubin before, during and after the procedure of exchange transfusion .
Diagnostic test: blood group,complete blood count
measure levels of total and direct bilirubin before, during and after the procedure of exchange transfusion
Other Names:
  • measure levels of total and direct bilirubin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum bilirubin estimation
Time Frame: 2 days
estimation of serum bilirubin
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 15, 2018

Primary Completion (Anticipated)

April 15, 2019

Study Completion (Anticipated)

September 15, 2019

Study Registration Dates

First Submitted

June 15, 2017

First Submitted That Met QC Criteria

June 21, 2017

First Posted (Actual)

June 22, 2017

Study Record Updates

Last Update Posted (Actual)

June 22, 2017

Last Update Submitted That Met QC Criteria

June 21, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COET

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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