NCT03284528

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2011

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2017

Completed
Last Updated

September 21, 2017

Status Verified

September 1, 2017

Enrollment Period

6 years

First QC Date

September 13, 2017

Last Update Submit

September 20, 2017

Conditions

Asphyxia Neonatorum

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

hypothermia therapyOTHER

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

Eligibility Criteria

Age1 Day - 4 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Children's hospital Zurich

Zurich, 8044, Switzerland

Location

MeSH Terms

Conditions

Asphyxia Neonatorum

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Barbara Brotschi

    University Childrens's hospital of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2017

First Posted

September 15, 2017

Study Start

January 1, 2011

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

September 21, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)