Complications of Exchange Transfusion in Neonates

NCT ID: NCT03195049

Last Updated: 2017-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-15

Study Completion Date

2019-09-15

Brief Summary

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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

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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.

Conditions

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Kernicterus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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blood group

blood is collected for maternal and infant blood group,complete blood count,before, during and after the procedure of exchange transfusion .

Group Type EXPERIMENTAL

blood group,complete blood count

Intervention Type DIAGNOSTIC_TEST

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

serum bilirubin estimation

estimation of serum bilirubin before, during and after the procedure of exchange transfusion .

Group Type EXPERIMENTAL

blood group,complete blood count

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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blood group,complete blood count

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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measure levels of total and direct bilirubin

Eligibility Criteria

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Inclusion Criteria

* All preterm and full term neonates who need exchange transfusion

Exclusion Criteria

* Neonatal sepsis
* Congenital anomalies
Minimum Eligible Age

1 Day

Maximum Eligible Age

4 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Zanaty

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hanaa Ab Mohamed, Professor

Role: STUDY_CHAIR

Assiut University

Central Contacts

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Hanaa Ab Mohamed, Professor

Role: CONTACT

00201120096055 ext. Assuit

Safwat Mo Abdel-Aziz, Lecturer

Role: CONTACT

00201003918080 ext. Assuit

References

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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. doi: 10.1542/peds.2006-2910.

Reference Type RESULT
PMID: 17606558 (View on PubMed)

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. doi: 10.1016/j.pcl.2004.03.011.

Reference Type RESULT
PMID: 15275978 (View on PubMed)

Other Identifiers

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COET

Identifier Type: -

Identifier Source: org_study_id

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