CoolCap Followup Study-Coordination of Participating Centers

NCT00581581 | Completed Results

• 1 other identifier: RSRB00020479
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study will assess long-term functional outcome of survivors from neonatal encephalopathy who were previously treated with either head cooling or with conventional care in a randomized clinical trial. Children's parents will be interviewed by phone by trained staff using the WeeFIM questionnaire to ascertain the childrens' functional performance on a set of skills basic to daily life. This instrument is able to assess a very wide range of abilities, from independently functioning to needing total assistance. The ratings will be used to examine the relationship between the outcome previously measured at 18 months age and functional outcome at school age and to triage the children into those who clearly could not be tested on standardized exams of cognitive functioning, those who potentially could, even if at a low level of cognitive ability, and those who appear to be functioning at an age-appropriate level.

Conditions

Neonatal Encephalopathy

Keywords

neonatal encephalopathy; therapeutic hypothermia; head cooling; neonatal asphyxia

Outcome Measures

Primary Outcomes (1)

• WeeFIM Score

  WeeFIM instrument (the Functional Independence Measure for Children, Uniform Data System for Medical Rehabilitation, Buffalo, NY) is a set of ratings of 18 skills divided into 3 general domains: 8 Self-care; 5 Mobility; 5 Cognition. Caregivers rate a child about extent of independence, full functioning, in carrying out each of those 18 skills, on a scale from "1" for total assistance, total dependence, maximal prompting, or not testable to "7" for complete independence. The ratings are combined to yield 3 Domain scores and a WeeFIM Total. Favorable=mean+/-2SD. We are reporting the percentage of participants with a favorable response.

  7-8 years after initial intervention

Study Arms (2)

1

Randomized to cooling (original randomized clinical trial): All children, now 6-8 years old who were randomized to cooling in the original trial were included in this arm. Cooling was achieved via the CoolCap system (Olympic Medical/Natus Corporation) in these babies.

2

Randomized to standard care (original randomized clinical trial): All children, now 6-8 years old, who were treated using the standard of care at the time (normal temperature) were included in this arm. Infants' temperatures were monitored per standard of care. Most infants were cared for on an open wamer that was servo-controlled to normal body temperature (37 C) or in a standard bassinette.

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Eligible children will be those who participated in the original randomized clinical trial, "Brain Cooling for the Treatment of Perinatal Hypoxic-Ischemic Encephalopathy". Infants enrolled in that study were randomized to cooling or standard care. Survivors to 7-8 years of age are eligible for this observational followup study.

You may qualify if:

• Previous participation in the CoolCap study
• Survivors to 7-8 years of age
• Parental consent to participation

You may not qualify if:

• Lack of parental consent

Sponsors & Collaborators

• University of Rochester: lead
• Olympic Medical: collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (2)

• Gluckman PD, Wyatt JS, Azzopardi D, Ballard R, Edwards AD, Ferriero DM, Polin RA, Robertson CM, Thoresen M, Whitelaw A, Gunn AJ. Selective head cooling with mild systemic hypothermia after neonatal encephalopathy: multicentre randomised trial. Lancet. 2005 Feb 19-25;365(9460):663-70. doi: 10.1016/S0140-6736(05)17946-X.

  PMID: 15721471 BACKGROUND

• Guillet R, Edwards AD, Thoresen M, Ferriero DM, Gluckman PD, Whitelaw A, Gunn AJ; CoolCap Trial Group. Seven- to eight-year follow-up of the CoolCap trial of head cooling for neonatal encephalopathy. Pediatr Res. 2012 Feb;71(2):205-9. doi: 10.1038/pr.2011.30. Epub 2011 Dec 21.

  PMID: 22258133 RESULT

MeSH Terms

Conditions

Asphyxia Neonatorum

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Ronnie Guillet, MD, PhD
• Organization: University of Rochester

ronnie_guille@urmc.rochester.edu

585-275-6209

Study Officials

• Ronnie Guillet, MD, PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: December 27, 2007
• Study Start: September 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: March 8, 2013
• Results First Posted: March 8, 2013

Record last verified: 2013-03

Locations

US (1)