Serum Erythropoietin Level in Perinatal Asphyxia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2021-06-15

Brief Summary

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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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Detailed Description

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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.

Conditions

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Perinatal Hypoxia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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cases

measure serum erythropoietin level

Serum erythropoietin level

Intervention Type DIAGNOSTIC_TEST

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

controls

measure serum erythropoietin level

Serum erythropoietin level

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Serum erythropoietin level

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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).

Minimum Eligible Age

1 Day

Maximum Eligible Age

4 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes