Trial Outcomes & Findings for Pilot Study of Head Cooling in Preterm Infants With Hypoxic Ischemic Encephalopathy (NCT NCT00620711)

NCT ID: NCT00620711

Last Updated: 2019-01-29

Results Overview

Measurement of number of participants able to obtain 12 degree cap temperature

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 4 participants
• Primary outcome timeframe: 60 minutes intervals up to 72 hours
• Results posted on: 2019-01-29

Participant Flow

Preterm Infants meeting criteria for HIE 6 hours old

Participant milestones

Measure	Group 1 Cool- Cap Applied While Maintaining Rectal Temp Babies that meet criteria will be offered participation in feasibility trial, there are no other arms.
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study of Head Cooling in Preterm Infants With Hypoxic Ischemic Encephalopathy

Baseline characteristics by cohort

Measure	Preter Infnats With HIE n=4 Participants Babies that meet criteria will be offered participation in feasibility trial, there are no other arms. Criteria include Sentinel evnet , Low Apgar, pH less than 7, Neonatal encephalopathy with no other cause and need for mechanical ventialtion Olympic Cool Cap: Olympic Cool Cap will be applied to infants 32-35 weeks gestation who meet criteria for HIE.
Age, Categorical <=18 years	4 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 60 minutes intervals up to 72 hours

Population: all analysized

Measurement of number of participants able to obtain 12 degree cap temperature

Outcome measures

Measure	Group 1 Cool- Cap Applied While Maintaining Rectal Temp n=4 Participants Babies that meet criteria will be offered participation in feasibility trial, there are no other arms.
Feasibility Trial- the Olympic Cool Cap Will be Applied, Can the Delivered Cap Temperature be Less Than 12 Degrees Without Changing Rectal Temperature.	2 participants

PRIMARY outcome

Timeframe: 6 hours

Yes/no

Outcome measures

Measure	Group 1 Cool- Cap Applied While Maintaining Rectal Temp n=4 Participants Babies that meet criteria will be offered participation in feasibility trial, there are no other arms.
Cap Cooled to 12 Degrees Without Reducing Rectal Temperature	2 participants

Adverse Events

Preterm Infants With HIE

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Preterm Infants With HIE n=4 participants at risk Babies that meet criteria will be offered participation in feasibility trial, there are no other arms. Olympic Cool Cap: Olympic Cool Cap will be applied to infants 32-35 weeks gestation who meet criteria for HIE.
General disorders Death	25.0% 1/4 • Number of events 2
Nervous system disorders Intracranial Hemorrhage	25.0% 1/4 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

William F Walsh

Vanderbilt university

Phone: 615-322-0545

Email: bill.walsh@vanderbilt.edu

Results disclosure agreements

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