Preemie Hypothermia for Neonatal Encephalopathy (NCT01793129) | Clinical Trial Compass
CompletedNot Applicable
Preemie Hypothermia for Neonatal Encephalopathy
United States168 participantsStarted 2015-05
Plain-language 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.
Who can participate
Age range33 Weeks – 35 Weeks
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …