Status:
COMPLETED
Preemie Hypothermia for Neonatal Encephalopathy
Lead Sponsor:
NICHD Neonatal Research Network
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Infant, Newborn
Hypoxia, Brain
Eligibility:
All Genders
33-35 years
Phase:
NA
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 post...
Detailed Description
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2022
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT01793129
Start Date
May 1 2015
End Date
December 9 2022
Last Update
November 4 2024
Active Locations (18)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Stanford University
Palo Alto, California, United States, 94304
3
Emory University
Atlanta, Georgia, United States, 30303
4
Indiana University
Indianapolis, Indiana, United States, 46202