Clinical trial NCT02826941: Moderate Hypothermia in Neonatal Hypoxic Ischemic Encephalopathy
Official title: Moderate Hypothermia in Neonatal Hypoxic Ischemic Encephalopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neonatal Asphyxial Encephalopathy
Hypoxic Ischemic Encephalopathy
Keywords: hypothermia treatment
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2016-07-11
Enrollment: 65
Sex: ALL
Minimum age (years): 35
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Death or severely abnormal Psychomotor Development Index scores on Bayley II
timeFrame: 12 months
Secondary outcomes:
measure: bradycardia
timeFrame: 0-96 hours
Other outcomes:
measure: coagulopathy
timeFrame: 1-4 days of life
measure: Death
timeFrame: by 12 months of age
Locations:
Study officials:
affiliation: Medical University of South Carolina
name: Dorothea D Jenkins, MD
role: PRINCIPAL_INVESTIGATOR
References:
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: efficacy outcomes. Pediatr Neurol. 2005 Jan;32(1):11-7. doi: 10.1016/j.pediatrneurol.2004.06.014.
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. doi: 10.1016/j.pediatrneurol.2004.06.015.
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 therapeutic hypothermia for neonatal hypoxic ischemic encephalopathy*. Pediatr Crit Care Med. 2013 Oct;14(8):786-95. doi: 10.1097/PCC.0b013e3182975cc9.
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 Cereb Blood Flow Metab. 2012 Oct;32(10):1888-96. doi: 10.1038/jcbfm.2012.83. Epub 2012 Jul 18.