Serum Erythropoietin Level in Perinatal Asphyxia

August 24, 2021 updated by: Ahmed Mahmoud Ahmed Sayed, Cairo University

Serum Erythropoietin Level for Detection of Kidney and Brain Injuries in Asphyxiated Neonates in Neonatal Intensive Care Unit.

This study is to evaluate brain and kidney injuries in full-term neonates with perinatal asphyxia by detecting specific biomarker in blood (Erythropoietin).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Perinatal hypoxic-ischemic encephalopathy (HIE) is an important cause of brain injury in the newborn and can result in long-term devastating consequences. Acute kidney injury (AKI) occurs in (50 - 72%) among asphyxiated term infants. The kidney cells that make erythropoietin are sensitive to low oxygen levels in the blood that travels through the kidney. These cells make and release erythropoietin when the oxygen level is too low.

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

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

Study Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of Medicine, Cairo University

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 days (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Data will be collected from full-term neonates (first 28 days of life) with perinatal hypoxia admitted in Neonatal Intensive Care Unit. Both sexes are included (males & females) .

Description

Inclusion Criteria:

Cases group:

  1. The presence of a sentinel hypoxic event immediately before or during delivery
  2. History of fetal distress (bradycardia, late decelerations, absence of heart rate variability).
  3. Need for neonatal resuscitation at delivery
  4. One-min Apgar score <3 or 5-minApgar score<7
  5. Metabolic acidosis (BE > 10 in cord blood)
  6. Cardiocirculatory instability (CCI), clinical indications of hypoxic-ischemic encephalopathy (HIE) and multiple organ involvement (MOI).

Control group:

Newborns who were delivered normally after uncomplicated pregnancy. None of them have clinical nor biochemical signs of asphyxia.

Exclusion Criteria:

  • Newborns who do not fulfill the above criteria.
  • Newborns with congenital heart diseases and perinatal hemolytic anemia or congenital liver affection.
  • Whose parents refuse to participate in the study.
  • Cases above 4 days old.
  • Preterm neonates (less than 37 weeks).

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
cases
measure serum erythropoietin level
Diagnostic test: Serum erythropoietin level
Evaluate serum erythropoietin level in neonates exposed to hypoxia compared to control group
controls
measure serum erythropoietin level
Diagnostic test: Serum erythropoietin level
Evaluate serum erythropoietin level in neonates exposed to hypoxia compared to control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation between serum erythropoietin level and brain injury
Time Frame: first 4 days of life
measure level of serum erythropoietin by ELISA technique and test if can differentiate degree of brain hypoxia
first 4 days of life

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Chair: Yosra Aboelnaga, Dryosra86@hotmail.com
  • Study Chair: Nermine Riad, docnermoo@gmail.com

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 (Actual)

August 1, 2020

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

June 15, 2021

Study Registration Dates

First Submitted

August 18, 2021

First Submitted That Met QC Criteria

August 18, 2021

First Posted (Actual)

August 24, 2021

Study Record Updates

Last Update Posted (Actual)

August 30, 2021

Last Update Submitted That Met QC Criteria

August 24, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS-222-2020

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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