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

Not Applicable

Completed

• Conditions: eonatal Hypoxic Ischaemic Encephalopathy; Cerebral Palsy; Neonatal Hypoxic Ischaemic Encephalopathy; Neurological - Other neurological disorders; Reproductive Health and Childbirth - Complications of newborn

• Registration Number: ACTRN12618000893202
• Lead Sponsor: Prof Roslyn Boyd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-28
• Study Completion: 2024-06-30
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

HIE Group:
(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:
• 3 out of 6 modified Sarnat criteria indicating moderate/severe encephalopathy;
• OR
• 2 out of 6 modified Sarnat criteria between one and six hours after birth, plus seizure(s) requiring anticonvulsant treatment (diagnosed either clinically or using EEG monitoring) at any time of study entry;
f) Hypothermia treatment initiated by 6 hours of age; i.e. controlled whole-body cooling planned to continue for 72 hours, to a target temperature (adjusted manually or with a device) and subsequent controlled re-warming
g) Informed consent;
h) Ability to receive 3T MRI at 1-10 days post-delivery (day 5-7 optimal) at 35+ weeks PMA (no metal inserts; i.e. no VP shunts)
In ADDITION the following babies not entered into the PAEAN intervention trial would be eligible for the NEBO observational trial:
i.Babies cooled too late
ii.Postnatal arrest with subsequent HIE
iii.Parents not approached (e.g. mother in ICU/too ill on 1st day)
iv.Babies whose parents declined PAEAN (not happy about an intervention trial but would agree to an observational study).
v.Babies who met all other criteria for PAEAN but had a contraindication to cooling – e.g. uncontrolled pulmonary hypertension or coagulopathy/bleeding – so didn’t get cooled.

Healthy term reference group:
Infants
a) born between 35 and 42 weeks gestation following an uncomplicated pregnancy and delivery,
b) have a birth weight above the 10th percentile
c) not admitted to neonatal intensive or special care units following their birth.

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity of Structural Magnetic Resonance Imaging (sMRI) in identifying children at risk of cerebral palsy will be compared to the results from the Gross Motor Function Classification System for Cerebral Palsy (GMFCS).[ 24 months corrected age];Specificity of Structural Magnetic Resonance Imaging (sMRI) in identifying children at risk of cerebral palsy will be compared to the results from the Gross Motor Function Classification System for Cerebral Palsy (GMFCS).[ 24 months corrected age]