Trial Outcomes & Findings for Safety and Efficacy of Hypothermia to Treat Neonatal Hypoxic-Ischemic Encephalopathy (NCT NCT00890409)

NCT ID: NCT00890409

Last Updated: 2009-05-28

Results Overview

The number of deaths by 18 months of age.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 256 participants
• Primary outcome timeframe: 18 months
• Results posted on: 2009-05-28

Participant Flow

Dates of the recruitment period: May 2002 to August 2005; Types of location: Children's Hospital or Women and Children's Medical Centre.

Participant milestones

Measure	Normothermia Rectal temperature in the group was maintained at 36 to 37.5 degree C.	Hypothermia The group was fitted with a cooling cap around the head for 72 hours. The temperature of the cap could be adjusted between 5 to 20 degree C and was automatically regulated by a servo-controlled temperature probe placed in the nasopharynx to maintain the nasopharyngeal temperature at (34±0.2)degree C.
Overall Study STARTED	116	140
Overall Study COMPLETED	96	119
Overall Study NOT COMPLETED	20	21

Reasons for withdrawal

Measure	Normothermia Rectal temperature in the group was maintained at 36 to 37.5 degree C.	Hypothermia The group was fitted with a cooling cap around the head for 72 hours. The temperature of the cap could be adjusted between 5 to 20 degree C and was automatically regulated by a servo-controlled temperature probe placed in the nasopharynx to maintain the nasopharyngeal temperature at (34±0.2)degree C.
Overall Study Lost to Follow-up	20	21

Baseline Characteristics

Safety and Efficacy of Hypothermia to Treat Neonatal Hypoxic-Ischemic Encephalopathy

Baseline characteristics by cohort

Measure	Normothermia n=116 Participants Rectal temperature in the group was maintained at 36 to 37.5 degree C.	Hypothermia n=140 Participants The group was fitted with a cooling cap around the head for 72 hours. The temperature of the cap could be adjusted between 5 to 20 degree C and was automatically regulated by a servo-controlled temperature probe placed in the nasopharynx to maintain the nasopharyngeal temperature at (34±0.2)degree C.	Total n=256 Participants Total of all reporting groups
Age, Customized <=6 hours	4.03 hour STANDARD_DEVIATION 1.21 • n=5 Participants	4.12 hour STANDARD_DEVIATION 1.59 • n=7 Participants	4.07 hour STANDARD_DEVIATION 1.38 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	25 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Male	97 Participants n=5 Participants	115 Participants n=7 Participants	212 Participants n=5 Participants

PRIMARY outcome

Timeframe: 18 months

The number of deaths by 18 months of age.

Outcome measures

Measure	Normothermia n=96 Participants Rectal temperature in the group was maintained at 36 to 37.5 degree C.	Hypothermia n=119 Participants The group was fitted with a cooling cap around the head for 72 hours. The temperature of the cap could be adjusted between 5 to 20 degree C and was automatically regulated by a servo-controlled temperature probe placed in the nasopharynx to maintain the nasopharyngeal temperature at (34±0.2)degree C.
Death	27 participants	22 participants

PRIMARY outcome

Timeframe: 18 months

Severe disability was defined as cerebral palsy (CP) or mental retardation (MR). The definition of MR was development quotient (DQ) <70 by Gesell's Child Development Scale and CP was based on the Criteria of a level 3 to 5 by the Gross Motor Function Classification System (GMFCS).

Outcome measures

Measure	Normothermia n=69 Participants Rectal temperature in the group was maintained at 36 to 37.5 degree C.	Hypothermia n=97 Participants The group was fitted with a cooling cap around the head for 72 hours. The temperature of the cap could be adjusted between 5 to 20 degree C and was automatically regulated by a servo-controlled temperature probe placed in the nasopharynx to maintain the nasopharyngeal temperature at (34±0.2)degree C.
Severe Neurodevelopmental Disability	19 participants	11 participants

SECONDARY outcome

Timeframe: 18 months

Major adverse events were defined as severe arrhythmia (II or III degree A-V block or atrial or ventricular arrhythmia), major venous thrombosis, refractory hypotension (mean blood pressure less than 40 mmHg), moderate or severe scleredema (greater or equal to 20% body surface area), and severe bleeding.

Outcome measures

Measure	Normothermia n=96 Participants Rectal temperature in the group was maintained at 36 to 37.5 degree C.	Hypothermia n=119 Participants The group was fitted with a cooling cap around the head for 72 hours. The temperature of the cap could be adjusted between 5 to 20 degree C and was automatically regulated by a servo-controlled temperature probe placed in the nasopharynx to maintain the nasopharyngeal temperature at (34±0.2)degree C.
Major Adverse Events	3 participants	4 participants

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Xiaomei Shao

Children's Hospital, Fudan University

Phone: 86-21-64931913

Email: zhou_wenhao@yahoo.com.cn

Results disclosure agreements

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