Serum Erythropoietin Level in Perinatal Asphyxia

Perinatal Hypoxia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05018364
• Other study ID #: MS-222-2020
• Status: Completed
• Start date: August 1, 2020
• Est. completion date: June 15, 2021

Study information

• Verified date: August 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 15, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 4 Days

Eligibility

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).

Related Conditions & MeSH terms

• Hypoxia
• Perinatal Hypoxia

Intervention

Diagnostic Test:
• Serum erythropoietin level
Evaluate serum erythropoietin level in neonates exposed to hypoxia compared to control group

Locations

Country	Name	City	State
Egypt	faculty of medicine, Cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Sweetman DU, Onwuneme C, Watson WR, Murphy JF, Molloy EJ. Perinatal Asphyxia and Erythropoietin and VEGF: Serial Serum and Cerebrospinal Fluid Responses. Neonatology. 2017;111(3):253-259. doi: 10.1159/000448702. Epub 2016 Dec 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correlation between serum erythropoietin level and brain injury	measure level of serum erythropoietin by ELISA technique and test if can differentiate degree of brain hypoxia	first 4 days of life