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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00620711
Recruitment Status : Completed
First Posted : February 21, 2008
Results First Posted : July 31, 2014
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
William Walsh, Vanderbilt University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hypoxic Ischemic Encephalopathy
Intervention Device: Olympic Cool Cap
Enrollment 4
Recruitment Details Preterm Infants meeting criteria for HIE 6 hours old
Pre-assignment Details  
Arm/Group Title Group 1 Cool- Cap Applied While Maintaining Rectal Temp
Hide Arm/Group Description Babies that meet criteria will be offered participation in feasibility trial, there are no other arms.
Period Title: Overall Study
Started 4
Completed 4
Not Completed 0
Arm/Group Title Preter Infnats With HIE
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
Preterm infants with HIE
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years
4
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
2
  50.0%
Male
2
  50.0%
1.Primary Outcome
Title Feasibility Trial- the Olympic Cool Cap Will be Applied, Can the Delivered Cap Temperature be Less Than 12 Degrees Without Changing Rectal Temperature.
Hide Description Measurement of number of participants able to obtain 12 degree cap temperature
Time Frame 60 minutes intervals up to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
all analysized
Arm/Group Title Group 1 Cool- Cap Applied While Maintaining Rectal Temp
Hide Arm/Group Description:
Babies that meet criteria will be offered participation in feasibility trial, there are no other arms.
Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: participants
2
2.Primary Outcome
Title Cap Cooled to 12 Degrees Without Reducing Rectal Temperature
Hide Description Yes/no
Time Frame 6 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Cool- Cap Applied While Maintaining Rectal Temp
Hide Arm/Group Description:
Babies that meet criteria will be offered participation in feasibility trial, there are no other arms.
Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: participants
2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Preterm Infants With HIE
Hide Arm/Group Description

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.

All-Cause Mortality
Preterm Infants With HIE
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Preterm Infants With HIE
Affected / at Risk (%) # Events
Total   2/4 (50.00%)    
General disorders   
Death [1]  1/4 (25.00%)  2
Nervous system disorders   
Intracranial Hemorrhage [2]  1/4 (25.00%)  1
[1]
Family withdrew patient due to poor prognosis
[2]
Intracranial hemorrhage
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Preterm Infants With HIE
Affected / at Risk (%) # Events
Total   0/4 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: William F Walsh
Organization: Vanderbilt university
Phone: 615-322-0545
EMail: bill.walsh@vanderbilt.edu
Layout table for additonal information
Responsible Party: William Walsh, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00620711    
Other Study ID Numbers: 070984
First Submitted: February 7, 2008
First Posted: February 21, 2008
Results First Submitted: May 28, 2014
Results First Posted: July 31, 2014
Last Update Posted: January 29, 2019