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Serum Erythropoietin Level in Perinatal Asphyxia

Cairo University (CU) logo

Cairo University (CU)

Status

Completed

Conditions

Perinatal Hypoxia

Treatments

Diagnostic Test: Serum erythropoietin level

Study type

Observational

Funder types

Other

Identifiers

NCT05018364
MS-222-2020

Details and patient eligibility

About

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

Full 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.

Enrollment

80 patients

Sex

All

Ages

1 to 4 days old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

80 participants in 2 patient groups

cases
Description:
measure serum erythropoietin level
Treatment:
Diagnostic Test: Serum erythropoietin level
controls
Description:
measure serum erythropoietin level
Treatment:
Diagnostic Test: Serum erythropoietin level

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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