Moderate Hypothermia in Neonatal Hypoxic Ischemic Encephalopathy

NCT02826941 | Completed Phase 2 DMC

• 2 other identifiers: NS38062R01NS038062
• Study Type: interventional
• Target: 65
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Neonatal Asphyxial Encephalopathy; Hypoxic Ischemic Encephalopathy

Keywords

hypothermia treatment

Outcome Measures

Primary Outcomes (1)

• Death or severely abnormal Psychomotor Development Index scores on Bayley II

  Death or severe outcomes

  12 months

Secondary Outcomes (1)

• bradycardia

  0-96 hours

Other Outcomes (2)

• coagulopathy

  1-4 days of life

• Death

  by 12 months of age

Study Arms (2)

Hypothermia

EXPERIMENTAL

If randomized to hypothermia, plastic bags filled with ice wrapped in a washcloth were applied to the head and body for approximately 2 hours, then the infant was placed on an adult-size, water-circulating, cooling blanket (Cincinnati Sub-Zero Blanketrol II®, Cincinnati, OH), servo-controlled to rectal temperature to 33 ± 0.5 °C for 48 hours at the participating tertiary care center. Rewarming by 0.5°C per hour was begun after 48 hours of hypothermia.

Other: hypothermia

Normothermia

PLACEBO COMPARATOR

If randomized to normothermia, rectal temperatures were maintained at 37 ± 0.5 °C per standard neonatal intensive care unit practice, using adult-size, water-circulating, cooling blanket (Cincinnati Sub-Zero Blanketrol II®, Cincinnati, OH), servo-controlled to rectal temperature of 37 ± 0.5 if baby was febrile.

Other: normothermia

Interventions

hypothermia OTHER

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

Also known as: whole body cooling

Hypothermia

normothermia OTHER

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.

Normothermia

Eligibility Criteria

• Age: 35 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Maternal chorioamnionitis,
• sepsis at birth,
• birth weight or head circumference \<10%,
• presumed chromosomal abnormality

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Related 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. doi: 10.1016/j.pediatrneurol.2004.06.014.

  PMID: 15607598 RESULT

• 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. doi: 10.1016/j.pediatrneurol.2004.06.015.

  PMID: 15607599 RESULT

• 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 therapeutic hypothermia for neonatal hypoxic ischemic encephalopathy*. Pediatr Crit Care Med. 2013 Oct;14(8):786-95. doi: 10.1097/PCC.0b013e3182975cc9.

  PMID: 23897243 RESULT

• 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 Cereb Blood Flow Metab. 2012 Oct;32(10):1888-96. doi: 10.1038/jcbfm.2012.83. Epub 2012 Jul 18.

  PMID: 22805873 RESULT

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dorothea D Jenkins, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: May 23, 2016
• First Posted: July 11, 2016
• Study Start: June 1, 1999
• Primary Completion: June 1, 2004
• Study Completion: June 1, 2004
• Last Updated: July 11, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will share