Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005772
Status:
COMPLETED
Last Update Posted:
2019-03-22
First Post:
2000-06-01
Brief Title:
Whole-Body Cooling for Birth Asphyxia in Term Infants
Sponsor:
NICHD Neonatal Research Network
Organization:
NICHD Neonatal Research Network
Study Overview
Official Title:
Randomized Controlled Trial of Hypothermia for Hypoxic-Ischemic Encephalopathy in Term Infants
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This large multicenter trial tested whether cerebral cooling initiated within 6 hours of birth and continued for 72 hours would reduce the risk of death and moderate to severe neurodevelopmental injury at 18-22 months corrected age Infants at least 36 weeks gestation with an abnormal blood gas within 1 hour of birth or a history of an acute perinatal event and a 10-min Apgar score 5 or continued need for ventilation were screened Following a neurological exam those with moderate to severe encephalopathy were randomized to a 72-hour period of total body cooling cooling blanket followed by slow re-warming The study was conducted in two phases Phase I 20 infants were examined for the safety of an esophageal temperature of 34-35 C Phase II main trial 200 infants were evaluated for the safety and efficacy of an esophageal temperature of 33-34 C Cardio-respiratory electroencephalograms EEGs renal metabolic and hematologic status and esophageal and abdominal skin temperature were monitored during the 72 hours of intervention Surviving children were given neurodevelopmental examinations at 18-22 months corrected age and again at school age 6-7 years of age
Detailed Description:
Perinatal cerebral hypoxia-ischemia injury is an important cause of death and neurodevelopmental disability Data from animal models suggest that brain cooling immediately after injury is neuroprotective Experience with total body cooling during surgery accidental near drownings and one Phase I trial of term infants suggest that it is effective and safe in children
This large multicenter trial tested whether cerebral cooling initiated within 6 hours of birth and continued for 72 hours would reduce the risk of death and moderate to severe neurodevelopmental injury at 18-22 months corrected age Infants at least 36 weeks gestation with an abnormal blood gas within 1 hour of birth or a history of an acute perinatal event and a 10-min Apgar score 5 or continued need for ventilation were screened Following a neurological exam those with moderate to severe encephalopathy were randomized to a 72-hour period of total body cooling cooling blanket followed by slow re-warming The study was conducted in two phases Phase I 20 infants were examined for the safety of an esophageal temperature of 34-35 C Phase II main trial 200 infants were evaluated for the safety and efficacy of an esophageal temperature of 33-34 C Cardio-respiratory electroencephalograms EEGs renal metabolic and hematologic status and esophageal and abdominal skin temperature were monitored during the 72 hours of intervention
Neurodevelopmental outcome was assessed at 18-22 mos of age by masked certified examiners The outcome at 18-22 months showed that whole-body cooling reduces the risk of death or moderate to severe disability in infants with hypoxic ischemic encephalopathy
Surviving infants were assessed at 6-7 years school age
This large multicenter trial tested whether cerebral cooling initiated within 6 hours of birth and continued for 72 hours would reduce the risk of death and moderate to severe neurodevelopmental injury at 18-22 months corrected age Infants at least 36 weeks gestation with an abnormal blood gas within 1 hour of birth or a history of an acute perinatal event and a 10-min Apgar score 5 or continued need for ventilation were screened Following a neurological exam those with moderate to severe encephalopathy were randomized to a 72-hour period of total body cooling cooling blanket followed by slow re-warming The study was conducted in two phases Phase I 20 infants were examined for the safety of an esophageal temperature of 34-35 C Phase II main trial 200 infants were evaluated for the safety and efficacy of an esophageal temperature of 33-34 C Cardio-respiratory electroencephalograms EEGs renal metabolic and hematologic status and esophageal and abdominal skin temperature were monitored during the 72 hours of intervention
Neurodevelopmental outcome was assessed at 18-22 mos of age by masked certified examiners The outcome at 18-22 months showed that whole-body cooling reduces the risk of death or moderate to severe disability in infants with hypoxic ischemic encephalopathy
Surviving infants were assessed at 6-7 years school age
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| M01RR016587 | NIH | None | httpsreporternihgovquickSearchM01RR016587 |
| U10HD021364 | NIH | None | None |
| U10HD021373 | NIH | None | None |
| U10HD021385 | NIH | None | None |
| U10HD021397 | NIH | None | None |
| U10HD027851 | NIH | None | None |
| U10HD027853 | NIH | None | None |
| U10HD027856 | NIH | None | None |
| U10HD027871 | NIH | None | None |
| U10HD027880 | NIH | None | None |
| U10HD027904 | NIH | None | None |
| U10HD034216 | NIH | None | None |
| U10HD040461 | NIH | None | None |
| U10HD040492 | NIH | None | None |
| U10HD040498 | NIH | None | None |
| U10HD040521 | NIH | None | None |
| U10HD040689 | NIH | None | None |
| M01RR000030 | NIH | None | None |
| M01RR000039 | NIH | None | None |
| M01RR000044 | NIH | None | None |
| M01RR000070 | NIH | None | None |
| M01RR000080 | NIH | None | None |
| M01RR000633 | NIH | None | None |
| M01RR000750 | NIH | None | None |
| M01RR006022 | NIH | None | None |
| M01RR007122 | NIH | None | None |
| M01RR008084 | NIH | None | None |