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Clinical Trials/ACTRN12618000893202
ACTRN12618000893202
Completed
未知

'Neonatal Encephalopathy Brain Outcomes (NEBO): Biomarkers in term born infants to improve accurate and earlier prediction of Cerebral Palsy

Prof Roslyn Boyd0 sites64 target enrollmentMay 28, 2018
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Conditionseonatal Hypoxic Ischaemic EncephalopathyCerebral PalsyNeonatal Hypoxic Ischaemic EncephalopathyNeurological - Other neurological disordersReproductive Health and Childbirth - Complications of newborn

Overview

Phase
未知
Intervention
Not specified
Conditions
eonatal Hypoxic Ischaemic Encephalopathy
Sponsor
Prof Roslyn Boyd
Enrollment
64
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 28, 2018
End Date
June 30, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Prof Roslyn Boyd

Eligibility Criteria

Inclusion Criteria

  • •(a) All babies who enter the Paean Trial, are eligible for the NEBO follow\-up trial.
  • •(b) Moderate to severe encephalopathy in the first 7 days after term delivery (greater than 35 plus weeks PMA) using the modified Sarnat classification;
  • •(c) Male or female infants born at 35 plus 0 weeks gestation with HIE (perinatal depression).
  • •(d) One or more of the following indications of perinatal depression:
  • •Apgar of 5 at 10 minutes after birth OR
  • •receiving ongoing resuscitation e.g. assisted ventilation (positive pressure ventilation or CPAP) or chest compressions at 10 minutes after birth OR
  • •on cord blood or arterial or venous blood obtained at less than 60 minutes after birth,
  • •pH less than 7\.00 OR
  • •base deficit of 12\.0 mmol/L.
  • •e) Moderate to severe encephalopathy, defined between one and six hours after birth by one or both of the following:

Exclusion Criteria

  • •(a)Unable to return for follow\-up;
  • •(b)Children with major congenital anomalies
  • •(c)Where cessation of life support is under active discussion

Outcomes

Primary Outcomes

Not specified

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