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Completed

NCT Number: NCT05018364

Serum Erythropoietin Level in Perinatal Asphyxia

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

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Key information

Conditions

Age range

1 day–4 day

Sex eligibility

All sexes

Study type

Observational

Primary location

faculty of medicine, Cairo university

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Cases group:

  • The presence of a sentinel hypoxic event immediately before or during delivery
  • History of fetal distress (bradycardia, late decelerations, absence of heart rate variability).
  • Need for neonatal resuscitation at delivery
  • One-min Apgar score <3 or 5-minApgar score<7
  • Metabolic acidosis (BE > 10 in cord blood)
  • 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).

Treatment and study plan

Serum erythropoietin level

Diagnostic Test

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 24, 2021
Registry last updated
Aug 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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