Clinical Trial: Preemie Hypothermia for Neonatal Encephalopathy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized Trial of Targeted Temperature Management With Whole Body Hypothermia For Moderate And Severe Hypoxic-Ischemic Encephalopathy In Premature Infants 33-35 Weeks Gestational Age.

Brief Summary: This study is a randomized, controlled trial to assess safety and effectiveness of whole body hypothermia for 72 hours in preterm infants 33-35 weeks gestational age (GA) who present at <6 hours postnatal age with moderate to severe neonatal encephalopathy (NE). The study will enroll infants with signs of NE at 18 NICHD Neonatal Research Network sites, and randomly assign them to either receive hypothermia or participate in a non-cooled control group.

Detailed Summary:

Most clinical studies of neonatal encephalopathy (NE) and potential interventions have focused on infants ≥36 weeks GA. Although many interventions have been suggested and assessed for prevention or palliation of NE, the only one currently supported by rigorous clinical evidence to improve outcome in human newborns has been hypothermia implemented at <6 hours of postnatal age and maintained for 72 hrs. Data about diagnosis, frequency, severity, and outcome of NE in infants 33-35 weeks GA are sparse.

This trial will assess safety and effectiveness of whole body hypothermia for 72 hours in preterm infants 33-35 weeks gestational age (GA) who present at <6 hrs postnatal age with moderate to severe neonatal encephalopathy. Infants 33 0/7 to 35 6/7 weeks GA (best obstetrical estimate) and greater than or equal to 1500 grams birth weight (selected to minimize potential difficulties placing esophageal probe) who meet clinical, biochemical and neurologic criteria for moderate to severe NE will be randomized to either whole body hypothermia or participate in a non-cooled control group. The primary outcome will be death or moderate to severe disability at 18-22 months corrected age. The presence or absence of disability will be determined by the standard NRN interdisciplinary follow-up exam.

Secondary Study includes determining an association between MRI detectable injury and neurodevelopment at 18-22 months.


Sponsor: NICHD Neonatal Research Network

Current Primary Outcome: Death or moderate or severe disability [ Time Frame: Birth to 18-22 months corrected age ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of deaths in the NICU and following discharge [ Time Frame: Birth to 18-22 months corrected age ]
  • Differences in MRI findings after cessation of cooling/control obtained [ Time Frame: Birth to 40 weeks corrected age ]
  • Number of infants with moderate and severe disability [ Time Frame: Birth to 18-22 months corrrected age ]
  • Causes of Death [ Time Frame: Birth to 18-22 months corrrected age ]
    withdrawal of support and reasons for such will be tracked; attempts will be made to obtain autopsy whenever possible
  • Neurological injury by cranial ultrasound within 24 hours of enrollment [ Time Frame: Birth to 2 days of life ]


Original Secondary Outcome: Same as current

Information By: NICHD Neonatal Research Network

Dates:
Date Received: February 13, 2013
Date Started: May 2015
Date Completion: October 2020
Last Updated: November 14, 2016
Last Verified: November 2016