Serum Erythropoietin Level in Perinatal Asphyxia

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05018364

Enrollment

Registered

2021-08-24

Start date

2020-08-01

Completion date

2021-06-15

Last updated

2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perinatal Hypoxia

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.

Interventions

DIAGNOSTIC_TESTSerum erythropoietin level

Evaluate serum erythropoietin level in neonates exposed to hypoxia compared to control group

Study design

Observational model

OTHER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

1 Days to 4 Days

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026