Moderate Hypothermia in Neonatal Hypoxic Ischemic Encephalopathy

Hypoxic Ischemic Encephalopathy Clinical Trial

Official title:

Moderate Hypothermia in Neonatal Hypoxic Ischemic Encephalopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02826941
• Other study ID #: NS38062
• Secondary ID: R01NS038062
• Status: Completed
• Phase: Phase 2
• First received: May 23, 2016
• Last updated: July 5, 2016
• Start date: June 1999
• Est. completion date: June 2004

Study information

• Verified date: July 2016
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring Board
• Study type: Interventional

Clinical Trial Summary

This study was a multicenter, randomized, controlled pilot trial of moderate systemic hypothermia (33°C) vs normothermia (37°C) for 48 hours in infants with neonatal encephalopathy instituted within 6 hours of birth or hypoxic-ischemic event.

Description:

The trial tested the ability to initiate systemic hypothermia in outlying hospitals and participating tertiary care centers, and determined the incidence of adverse neurologic outcomes of death and developmental scores at 12 months by Bayley II or Vineland tests between normothermic and hypothermic groups. This trial identified potential safety outcomes, compared the adverse effects of hypothermia among hypoxic-ischemic encephalopathy (HIE) infants in the normothermic and hypothermic treatment groups, and obtained rates of adverse outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: June 2004
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Weeks and older

Eligibility

Inclusion Criteria:

One clinical indication of hypoxic-ischemic injury

• cord gas pH = 7.0 or base deficit =13,

• initial infant gas pH < 7.1,

• Apgar score =5 at 10 minutes,

• continued resuscitation after 5 min,

• fetal bradycardia with heart rate < 80 beats per minute lasting =15 min,

• postnatal event O2 sat <70% or arterial O2<35 for 20 min with ischemia

And two neurologic findings of neonatal encephalopathy, abnormalities of:

• tone,

• reflexes,

• state of consciousness,

• seizures,

• posturing,

• autonomic dysfunction

Exclusion Criteria:

• Maternal chorioamnionitis,

• sepsis at birth,

• birth weight or head circumference <10%,

• presumed chromosomal abnormality

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Diseases
• Brain Ischemia
• Hypothermia
• Hypoxia-Ischemia, Brain
• Hypoxic Ischemic Encephalopathy
• Ischemia
• Neonatal Asphyxial Encephalopathy

Intervention

Other:
• hypothermia
Systemic hypothermia by Cincinnati Sub-Zero Blanketrol II®, servo-controlled to 33.0 degrees C rectal temperature, started within 6hours of hypoxic ischemic birth, and continued for 48hours
• normothermia
Rectal temperatures in neonates receiving normothermia were maintained at 37.0+or -0.5 degrees C, using overhead warmer or Cincinnati Sub-Zero Blanketrol II®, servo-controlled to rectal temperature of 37.0 degrees C.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute of Neurological Disorders and Stroke (NINDS)

References & Publications (4)

Eicher DJ, Wagner CL, Katikaneni LP, Hulsey TC, Bass WT, Kaufman DA, Horgan MJ, Languani S, Bhatia JJ, Givelichian LM, Sankaran K, Yager JY. Moderate hypothermia in neonatal encephalopathy: efficacy outcomes. Pediatr Neurol. 2005 Jan;32(1):11-7. — View Citation

Eicher DJ, Wagner CL, Katikaneni LP, Hulsey TC, Bass WT, Kaufman DA, Horgan MJ, Languani S, Bhatia JJ, Givelichian LM, Sankaran K, Yager JY. Moderate hypothermia in neonatal encephalopathy: safety outcomes. Pediatr Neurol. 2005 Jan;32(1):18-24. — View Citation

Jenkins DD, Lee T, Chiuzan C, Perkel JK, Rollins LG, Wagner CL, Katikaneni LP, Bass WT, Kaufman DA, Horgan MJ, Laungani S, Givelichian LM, Sankaran K, Yager JY, Martin R. Altered circulating leukocytes and their chemokines in a clinical trial of therapeut — View Citation

Jenkins DD, Rollins LG, Perkel JK, Wagner CL, Katikaneni LP, Bass WT, Kaufman DA, Horgan MJ, Languani S, Givelichian L, Sankaran K, Yager JY, Martin RH. Serum cytokines in a clinical trial of hypothermia for neonatal hypoxic-ischemic encephalopathy. J Cer — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	coagulopathy	Mean Prothrombin time	1-4 days of life	Yes
Other	Death	numbers of patients who are withdrawn from support or die from multiorgan system failure	by 12 months of age	Yes
Primary	Death or severely abnormal Psychomotor Development Index scores on Bayley II	Death or severe outcomes	12 months	No
Secondary	bradycardia	number of patients with heart rate < 80 bpm	0-96 hours	Yes