Serum Erythropoietin Level in Perinatal Asphyxia
Serum Erythropoietin Level for Detection of Kidney and Brain Injuries in Asphyxiated Neonates in Neonatal Intensive Care Unit.
1 other identifier
observational
80
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2021
CompletedFirst Submitted
Initial submission to the registry
August 18, 2021
CompletedFirst Posted
Study publicly available on registry
August 24, 2021
CompletedAugust 30, 2021
August 1, 2021
10 months
August 18, 2021
August 24, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
cases
measure serum erythropoietin level
controls
measure serum erythropoietin level
Interventions
Evaluate serum erythropoietin level in neonates exposed to hypoxia compared to control group
Eligibility Criteria
Data will be collected from full-term neonates (first 28 days of life) with perinatal hypoxia admitted in Neonatal Intensive Care Unit. Both sexes are included (males \& females) .
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
faculty of medicine, Cairo university
Cairo, Egypt
Related 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.
PMID: 27902983BACKGROUND
Study Officials
- STUDY CHAIR
Yosra Aboelnaga
Dryosra86@hotmail.com
- STUDY CHAIR
Nermine Riad
docnermoo@gmail.com
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
August 18, 2021
First Posted
August 24, 2021
Study Start
August 1, 2020
Primary Completion
June 1, 2021
Study Completion
June 15, 2021
Last Updated
August 30, 2021
Record last verified: 2021-08