Preemie Hypothermia for Neonatal Encephalopathy
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| ClinicalTrials.gov Identifier: NCT01793129 |
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Recruitment Status :
Completed
First Posted : February 15, 2013
Last Update Posted : December 20, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Infant, Newborn Hypoxia, Brain Hypoxia-Ischemia, Brain Encephalopathy, Hypoxic-Ischemic Hypoxic-Ischemic Encephalopathy Ischemic-Hypoxic Encephalopathy | Device: Hypothermia Procedure: Normothermic Control | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 168 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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. |
| Study Start Date : | May 2015 |
| Actual Primary Completion Date : | December 9, 2022 |
| Actual Study Completion Date : | December 9, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Whole-body Hypothermia
Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 72 hours
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Device: Hypothermia
Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 72 hours |
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Placebo Comparator: Normothermia
Control group (with esophageal temperature at or near 37.0°C) for 72 hours
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Procedure: Normothermic Control
Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours |
- Death or moderate or severe disability [ Time Frame: Birth to 18-22 months corrected age ]
- 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 ]
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| Ages Eligible for Study: | 33 Weeks to 35 Weeks (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Infants 33 0/7 to 35 6/7 weeks GA (best obstetrical estimate)
- Infants weight greater than or equal to 1500 grams at birth
- Postnatal age less than 6 hours
- Infants who meet clinical, biochemical and neurologic criteria for moderate to severe NE:
Biochemical: Cord gas or blood gas within first hour of life with pH ≤7.00 or base deficit (BD) ≥16 mEq/L OR
Acute perinatal event (e.g., abruptio placenta, cord prolapse, uterine rupture, severe FHR abnormality such as variable or late decelerations) AND Requirement for positive pressure ventilation for apnea or poor respiratory effort since birth for at least 10 minutes OR 10 minute Apgar score ≤5
AND
Neurologic:
Seizures OR modified Sarnat score with abnormalities in at least 3 of the 6 categories; at least one must be altered level of consciousness (lethargy or stupor/coma) as determined by a certified examiner (All infants who meet criteria for potential inclusion will undergo standard neurologic exam as for infants ≥36 wks GA being considered for hypothermia, with findings recorded)
Exclusion Criteria:
- Receipt of sedative, analgesic or paralytic agent that may confound the qualifying neurologic exam
- Etiology of NE not likely to be hypoxic-ischemic in origin
- Major congenital anomaly that may confound outcome
- Considered to be moribund and will not be receiving full intensive care
- Equipment and/or appropriate staff not available
- Core temperature < 33.5oC for more than one hour at time of screening
- Unable to randomize by 6 hours of age
- Infant needs ECMO
- All blood gases (cord and postnatal at < 1hr of age) have a pH > 7.15 AND a base deficit < 10mEq/L
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01793129
Show 18 study locations
| Principal Investigator: | Michele C Walsh, MD | Case Western Reserve University, Rainbow Babies and Children's Hospital | |
| Principal Investigator: | Seetha Shankaran, MD | Wayne State University | |
| Principal Investigator: | Abbot R Laptook, MD | Brown University, Women & Infants Hospital of Rhode Island | |
| Principal Investigator: | C. Michael Cotten, MD | Duke University | |
| Principal Investigator: | David P Carlton, MD | Emory University | |
| Principal Investigator: | Greg Sokol, MD, MS | Indiana University | |
| Principal Investigator: | Abhik Das, PhD | RTI International | |
| Principal Investigator: | Krisa P Van Meurs, MD | Stanford University | |
| Principal Investigator: | Brenda Poindexter, MD | Children's Hospital Medical Center, Cincinnati | |
| Principal Investigator: | Wally A Carlo, MD | University of Alabama at Birmingham | |
| Principal Investigator: | Edward F Bell, MD | University of Iowa | |
| Principal Investigator: | Kristi L Watterberg, MD | University of New Mexico | |
| Principal Investigator: | Myra Wyckoff, MD | University of Texas Southwestern Medical Center at Dalla | |
| Principal Investigator: | Jon E Tyson, MD, MPH | The University of Texas Health Science Center, Houston | |
| Principal Investigator: | Eric Eichenwald, MD | University of Pennsylvania | |
| Principal Investigator: | Carl T D'Angio, MD | University of Rochester | |
| Principal Investigator: | Pablo Sanchez, MD | Research Institute at Nationwide Children's Hospital | |
| Principal Investigator: | Bradley Yoder, MD | University of Utah |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
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NICHD Neonatal Research Network Hypoxic-ischemic encephalopathy (HIE) Hypothermia Neonatal depression Perinatal asphyxia |
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Brain Diseases Brain Ischemia Hypoxia-Ischemia, Brain Hypoxia, Brain Ischemia Hypoxia Hypothermia Pathologic Processes |
Signs and Symptoms, Respiratory Central Nervous System Diseases Nervous System Diseases Body Temperature Changes Cerebrovascular Disorders Vascular Diseases Cardiovascular Diseases |