Trial Outcomes & Findings for The TOBY Children Study (NCT NCT01092637)

NCT ID: NCT01092637

Last Updated: 2016-01-21

Results Overview

IQ was measured using WPPSI III core tests

• Recruitment status: COMPLETED
• Target enrollment: 280 participants
• Primary outcome timeframe: 7 years 3 months
• Results posted on: 2016-01-21

Participant Flow

Participant milestones

Measure	Cooled Child was allocated standard intensive care plus moderate whole body hypothermia treatment within 6 hours of birth. Cooling lasted for 72 hours then gradually rewarmed, after which normothermia was maintained. Between age 6 yr and 7 yr 3m child and family invited to participate in follow-up study. Questionnaire data collected from Parent(s) and Teacher(s). Paediatrician and Psychologist visited child in school or at home. Paediatrician neurodevelopmental examination completed and documented on Paediatrician Questionnaire. Psychologist completed the following tests: * Wechsler Pre-School and Primary Scale of Intelligence Third edition (WPPSI III) * NEPSY II selected sub-tests * Working Memory Test Battery for Children (WMTB-C) Assessors were blinded to original trial treatment allocation.	Non-cooled Child was allocated standard intensive care only within 6 hours of birth. Normothermia was maintained throughout. Between age 6 yr and 7 yr 3m child and family invited to participate in follow-up study. Questionnaire data collected from Parent(s) and Teacher(s). Paediatrician and Psychologist visited child in school or at home. Paediatrician neurodevelopmental examination completed and documented on Paediatrician Questionnaire. Psychologist completed the following tests: * Wechsler Pre-School and Primary Scale of Intelligence Third edition (WPPSI III) * NEPSY II selected sub-tests * Working Memory Test Battery for Children (WMTB-C) Assessors were blinded to original trial treatment allocation.
Overall Study STARTED	145	135
Overall Study COMPLETED	98	86
Overall Study NOT COMPLETED	47	49

Reasons for withdrawal

Measure	Cooled Child was allocated standard intensive care plus moderate whole body hypothermia treatment within 6 hours of birth. Cooling lasted for 72 hours then gradually rewarmed, after which normothermia was maintained. Between age 6 yr and 7 yr 3m child and family invited to participate in follow-up study. Questionnaire data collected from Parent(s) and Teacher(s). Paediatrician and Psychologist visited child in school or at home. Paediatrician neurodevelopmental examination completed and documented on Paediatrician Questionnaire. Psychologist completed the following tests: * Wechsler Pre-School and Primary Scale of Intelligence Third edition (WPPSI III) * NEPSY II selected sub-tests * Working Memory Test Battery for Children (WMTB-C) Assessors were blinded to original trial treatment allocation.	Non-cooled Child was allocated standard intensive care only within 6 hours of birth. Normothermia was maintained throughout. Between age 6 yr and 7 yr 3m child and family invited to participate in follow-up study. Questionnaire data collected from Parent(s) and Teacher(s). Paediatrician and Psychologist visited child in school or at home. Paediatrician neurodevelopmental examination completed and documented on Paediatrician Questionnaire. Psychologist completed the following tests: * Wechsler Pre-School and Primary Scale of Intelligence Third edition (WPPSI III) * NEPSY II selected sub-tests * Working Memory Test Battery for Children (WMTB-C) Assessors were blinded to original trial treatment allocation.
Overall Study Death	47	49

Baseline Characteristics

The TOBY Children Study

Baseline characteristics by cohort

Measure	Cooled n=145 Participants Child was allocated standard intensive care plus moderate whole body hypothermia treatment within 6 hours of birth	Non-cooled n=135 Participants Child was allocated standard intensive care only within 6 hours of birth	Total n=280 Participants Total of all reporting groups
Age, Continuous	6.27 years n=5 Participants	6.24 years n=7 Participants	6.25 years n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	61 Participants n=7 Participants	115 Participants n=5 Participants
Sex: Female, Male Male	91 Participants n=5 Participants	74 Participants n=7 Participants	165 Participants n=5 Participants

PRIMARY outcome

Timeframe: 7 years 3 months

Population: Children for whom IQ data at age 6-7 yr were available

IQ was measured using WPPSI III core tests

Outcome measures

Measure	Cooled n=98 Participants Allocated cooling treatment at randomization to original trial. See full description in Participant flow section.	Non-cooled n=86 Participants Allocated standard treatment (normothermia) at randomization to original trial. See full description in Participant flow section.
Number of Survivors With an IQ > 84	75 participants	52 participants

SECONDARY outcome

Timeframe: 7 years 3 months

Population: Number of participants without disability. Two particpants in the cooled group and three in the non-cooled group could not be classified.

IQ =>85, no neurological abnormalities, normal hearing, normal vision

Outcome measures

Measure	Cooled n=96 Participants Allocated cooling treatment at randomization to original trial. See full description in Participant flow section.	Non-cooled n=83 Participants Allocated standard treatment (normothermia) at randomization to original trial. See full description in Participant flow section.
Number of Survivors Without Disability	65 participants	37 participants

SECONDARY outcome

Timeframe: 7 years 3 months

Population: Number of participants with cerebral palsy

Number of participants diagnosed with Cerebral Palsy

Outcome measures

Measure	Cooled n=98 Participants Allocated cooling treatment at randomization to original trial. See full description in Participant flow section.	Non-cooled n=86 Participants Allocated standard treatment (normothermia) at randomization to original trial. See full description in Participant flow section.
Number of Survivors With Cerebral Palsy	21 participants	31 participants

Adverse Events

Cooled

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-cooled

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinical Trials Unit

National Perinatal Epidemiology Unit, University of Oxford

Phone: +44 1865 289700

Email: ctu@npeu.ox.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place