Serum Erythropoietin Level in Perinatal Asphyxia

Completed

• Conditions: Perinatal Hypoxia
• Interventions: Diagnostic Test: Serum erythropoietin level

• Registration Number: NCT05018364
• Lead Sponsor: Cairo University

Brief Summary

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

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 Timeline

• Study Start: 2020-08-01
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-15
• Status Verified: 2021-08
• Study First Submitted: 2021-08-18
• Study First Submitted QC: 2021-08-18
• Study First Posted: 2021-08-24
• Last Update Submitted: 2021-08-24
• Last Update Posted: 2021-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
cases	Serum erythropoietin level	measure serum erythropoietin level
controls	Serum erythropoietin level	measure serum erythropoietin level

Primary Outcome Measures

Name	Time	Method
correlation between serum erythropoietin level and brain injury	first 4 days of life	measure level of serum erythropoietin by ELISA technique and test if can differentiate degree of brain hypoxia

Trial Locations

Locations (1)

faculty of medicine, Cairo university; 🇪🇬 Cairo, Egypt