Cooling in Mild Encephalopathy

PHASE3RecruitingINTERVENTIONAL
Enrollment

426

Participants

Timeline

Start Date

March 15, 2024

Primary Completion Date

January 1, 2030

Study Completion Date

January 1, 2030

Conditions
Neonatal EncephalopathyNewborn Asphyxia
Interventions
PROCEDURE

Whole body hypothermia

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.

PROCEDURE

Targeted normothermia

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.

OTHER

Supportive neonatal intensive care

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

DIAGNOSTIC_TEST

Follow up assessment at 2 years of age

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.

Trial Locations (15)

Unknown

RECRUITING

"Neonatal Unit, Università degli Studi della Campania Luigi Vanvitelli", Naples

RECRUITING

Medway Maritime Hospital, Gillingham

RECRUITING

Liverpool Women's Hospital, Liverpool

RECRUITING

Homerton University Hospital, London

RECRUITING

Imperial College Healthcare NHS FT, London

TN24 0LZ

RECRUITING

William Harvey Hospital, Ashford

BN2 5BE

RECRUITING

Royal Sussex County Hospital, Brighton

BS2 8EG

RECRUITING

St Michael's Hospital, Bristol

DA2 8DA

RECRUITING

Darent Valley Hospital, Dartford

RH16 4EX

RECRUITING

Princess Royal Hospital, Haywards Heath

OX3 9DU

NOT_YET_RECRUITING

John Radcliffe Hospital, Oxford

PL6 8DH

RECRUITING

Derriford Hosptial, Plymouth

TN2 4QJ

RECRUITING

Turnbridge Wells Hospital, Royal Tunbridge Wells

SO16 6YD

NOT_YET_RECRUITING

Southampton General Hospital, Southampton

BN11 2DH

RECRUITING

Worthing Hospital, Worthing

All Listed Sponsors
lead

Imperial College London

OTHER