Health TrialsbyHealthPanel

Cooling in Mild Encephalopathy

ConditionsNeonatal EncephalopathyNewborn Asphyxia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1-6
SponsorImperial College London

About this trial

The goal of this randomised control trial is to establish the safety and efficacy of whole-body hypothermia for babies with mild hypoxic ischaemic encephalopathy, inform national and international guidelines, and establish uniform practice across the NHS.

The main questions it aims to answer are:

1. Does whole-body cooling (33.5±0.5°C) initiated within six hours of birth and continued for 72 hours, improve cognitive development at 24 (±2) months of age after mild neonatal encephalopathy compared with normothermia (37±0.5°C)? 2. Does a prospective trial-based economic evaluation support the provision of cooling therapy for mild encephalopathy in the NHS on cost-effectiveness grounds?

Participants will have the following interventions:

* Randomisation into one of the following groups

* Whole body hypothermia group * Targeted normothermia group * Bayley Scales of Infant and Toddler Development 4th Edition (Bayley-IV) examination at 24 (±2) months of age.

Researchers will compare the mean Cognitive Composite Scale score from the Bayley IV examination between the two groups.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Infants who meet the BAPM criteria for whole-body hypothermia

Infants without encephalopathy defined as less than two abnormalities on structured neurological examination.

Infants with major congenital or chromosomal anomalies identified prior to randomisation.

Infants with birthweight <1800g.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Whole body hypothermia

    Procedure/Surgery

    Whole-body hypothermia (33.5±0.5°C) initiated within 6 hours of birth and continued for 72 hours. The rectal temperature will be maintained at 33.5±0.5°C using a servo-controlled cooling machine.

  • Targeted normothermia

    Procedure/Surgery

    The axillary temperature will be maintained at 37±0.5°C for the first 80 hours and any hyperthermia will be treated with a standardised protocol.

  • Supportive neonatal intensive care

    Other intervention

    Neonatal intensive care monitoring and support including ventilatory and inotropic support as clinically indicated

  • Follow up assessment at 2 years of age

    Diagnostic test

    The assessment will be carried out using the Bayley Scales of Infant and Toddler Development IV. In addition, all infants will have a detailed neurological examination, including Gross Motor Function Classification System (GMFCS) for cerebral palsy, vision, and hearing assessment. Babies who die or who cannot be assessed with the Bayley-IV due to severe disability will be allocated a Cognitive Scale Composite score one point below the basal test score. PARCA-R will be completed by the parents immediately.

Treatment groups

426 Participants
are divided into 2 treatment groups
Group A: Whole body hypothermiaExperimental treatment 3 interventions
Group B: NormothermiaActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Mean Cognitive Composite Scale score from the Bayley IV examination

The Bayley scales of Infant and toddler development IV is a validated and standardised scoring system that assesses development of three domains, that is cognition, language, and motor development. Babies who die or who cannot be assessed with the Bayley IV due to severe disability will be allocated a Cognitive Scale Composite score one point below the basal test score similar to the previous whole-body hypothermia trials.

Time frame
22 to 26 months

Secondary outcomes

1

Neonatal seizures

Definite seizures: seizures confirmed on EEG with or without clinical manifestations or Level 2-Probable seizure: clinically assessed focal clonic/ focal tonic seizure or seizures confirmed on aEEG.

Time frame
During neonatal hospitalisation (Expected average of 2 weeks)
2

Duration of intensive care.

Number of days of neonatal intensive care.

Time frame
During neonatal hospitalisation (Expected average of 2 weeks)
3

Duration of hospital stay.

Total number of days of inpatient care in a neonatal unit.

Time frame
During neonatal hospitalisation (Expected average of 2 weeks).
4

Duration of mechanical ventilation.

Number of hours on invasive ventilation through an endotracheal tube.

Time frame
During neonatal hospitalisation (Expected average of 2 weeks).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Imperial College London

Lead sponsor

Source ClinicalTrials.gov
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