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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03284528
Recruitment Status : Completed
First Posted : September 15, 2017
Last Update Posted : September 21, 2017
Sponsor:
Information provided by (Responsible Party):
University Children's Hospital, Zurich

Brief 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.

Condition or disease Intervention/treatment
Asphyxia Neonatorum Other: hypothermia therapy

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Does Placenta Pathology Predict Outcome of Neonates With Hypoxic Ischemic Encephalopathy?"
Actual Study Start Date : January 1, 2011
Actual Primary Completion Date : January 1, 2017
Actual Study Completion Date : January 1, 2017

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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).


Primary Outcome Measures :
  1. neurodevelopmental outcome at 18-24 month of Age [ Time Frame: 7 years ]
    The investigators will analyse if there is a correlation of placenta histology and neurodevelopmental outcome



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Ages Eligible for Study:   up to 4 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All newborn infants with a gestational Age >35 weeks, fulfilling the inclusion criteria of perinatal asphyxia and hypoxic-ischaemic encephalopathy, born in Switzerland and treated in the University Hospital of Zurich with hypothermia therapy after birth
Criteria

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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03284528


Locations
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Switzerland
University Children's hospital Zurich
Zurich, Switzerland, 8044
Sponsors and Collaborators
University Children's Hospital, Zurich
Investigators
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Principal Investigator: Barbara Brotschi University Childrens's hospital of Zurich
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Responsible Party: University Children's Hospital, Zurich
ClinicalTrials.gov Identifier: NCT03284528    
Other Study ID Numbers: 2017-00912
First Posted: September 15, 2017    Key Record Dates
Last Update Posted: September 21, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Diseases
Brain Ischemia
Hypoxia-Ischemia, Brain
Asphyxia Neonatorum
Asphyxia
Central Nervous System Diseases
Nervous System Diseases
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain
Death
Pathologic Processes
Wounds and Injuries
Infant, Newborn, Diseases