N/A N=168 Randomized Treatment

Preemie Hypothermia for Neonatal Encephalopathy

Infant, Newborn · Hypoxia, Brain · Hypoxia-Ischemia, Brain · Encephalopathy, Hypoxic-Ischemic · Hypoxic-Ischemic Encephalopathy

Bottom Line

View on ClinicalTrials.gov: NCT01793129 ↗

Enrolled (actual)

168

Serious AEs

27.7%

Results posted

Apr 2024

Primary outcome: Primary: Death or Moderate or Severe Disability — 29; 20 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Hypothermia (Device); Normothermic Control (Procedure)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: NICHD Neonatal Research Network
Primary completion: Dec 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Death or Moderate or Severe Disability	29; 20	—
SECONDARY Number of Deaths in the NICU and Following Discharge	18; 9	—
SECONDARY Number of Infants With Abnormal MRIs During Post-intervention Period	48; 50	—
SECONDARY Number of Infants With Moderate or Severe Disability	11; 11	—
SECONDARY Causes of Death	14; 4; 2; 2; 1; 0	—
SECONDARY Neurological Injury by Cranial Ultrasound During Intervention	2; 3	—

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.

Eligibility Criteria

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 7.15 AND a base deficit < 10mEq/L

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01793129). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.