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NCT03284528 Clinical Trial

Does Placenta Pathology Predict Outcome of Neonates With Hypoxic Ischemic Encephalopathy?"

Asphyxia Neonatorum Clinical Trial

Official title:
Does Placenta Pathology Predict Outcome of Neonates With Hypoxic Ischemic Encephalopathy?"

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03284528
Other study ID # 2017-00912
Secondary ID
Status Completed
Phase N/A
First received September 13, 2017
Last updated September 20, 2017
Start date January 1, 2011
Est. completion date January 1, 2017

Study information
Verified date September 2017
Source University Children's Hospital, Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The histology of the placenta of newborn infants with perinatal asphyxia and hypoxic-ischaemic encephalopathy is analysed. There will be an evaluation if placenta could be a biomarker for neurodevelopmental outcome at 18-24 months of age.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date January 1, 2017
Est. primary completion date January 1, 2017
Accepts healthy volunteers No
Gender All
Age group N/A to 4 Days
Eligibility Inclusion Criteria:all newborn infants with APGAR <5 at 10minutes, pH<7.0, lactate >12mmol/L, base excess >16, resuscitation >10min after birth, gestational age >35 weeks and an encephalopathy -

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• hypothermia therapy
newborn infants with hypoxic-ischaemic encephalopathy are cooled for 72 hours with a target temperature of 33-34°C (whole body cooling).

Locations
Country Name City State
Switzerland University Children's hospital Zurich Zurich

Sponsors (1)
Lead Sponsor Collaborator
University Children's Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary neurodevelopmental outcome at 18-24 month of Age The investigators will analyse if there is a correlation of placenta histology and neurodevelopmental outcome 7 years
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