N/A
N=168
Late Hypothermia for Hypoxic-Ischemic Encephalopathy
Infant, Newborn · Hypoxia, Brain · Hypoxia-Ischemia, Brain · Encephalopathy, Hypoxic-Ischemic · Hypoxic-Ischemic Encephalopathy
Bottom Line
View on ClinicalTrials.gov: NCT00614744 ↗Enrolled (actual)
168
Serious AEs
3.6%
Results posted
Aug 2017
Primary outcome: Primary: Death or Moderate or Severe Disability — 19; 22 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hypothermia (Procedure); Normothermic Control (Procedure)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- NICHD Neonatal Research Network
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Death or Moderate or Severe Disability |
19; 22 | — |
| SECONDARY Number of Deaths in the NICU and Following Discharge |
9; 9 | — |
| SECONDARY Number of Infants With Moderate and Severe Disability |
10; 13 | — |
| SECONDARY Number of Infants With Mild, Moderate and Severe Disability |
26; 25 | — |
| SECONDARY Number of Infants With Any Disability Based on Level of Encephalopathy at Randomization |
24; 25; 2; 0; 26; 25 | — |
| SECONDARY Number of Infants With Non-CNS Organ System Dysfunction |
63; 59 | — |
| SECONDARY Number of Infants With a DNR Order |
7; 8 | — |
| SECONDARY Number of Infants With a DNR Order and Support is Withdrawn |
6; 8 | — |
| SECONDARY Number of Infants With a DNR Order That Died |
5; 7 | — |
| SECONDARY Number of Infants With Neonatal Seizures, With and Without EEG Abnormalities |
63; 56 | — |
Summary
This study is a randomized, placebo-controlled, clinical trial to evaluate whether induced whole-body hypothermia initiated between 6-24 hours of age and continued for 96 hours in infants ≥ 36 weeks gestational age with hypoxic-ischemic encephalopathy will reduce the incidence of death or disability at 18-22 months of age. The study will enroll 168 infants with signs of hypoxic-ischemic encephalopathy at 16 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 born at 36 0/7ths weeks gestational age or greater (by best obstetrical estimate)
- Postnatal age between 6 and 24 hours following birth
- Infants with a high probability of acute hemodynamic compromise, such as those with:
- An acute perinatal event (abruptio placenta, cord prolapse, severe FHR abnormality)
- An Apgar score ≤ 5 at 10 minutes
- Continued need for ventilation initiated at birth for at least 10 minutes
- Cord pH or first postnatal blood gas pH at ≤ 1 hour of ≤ 7.0
- Base deficit on cord gas or first postnatal blood gas at ≤ 1 hour of ≥ 16 mEq/L
- Infants matching the above criteria who also have an abnormal neurological exam showing the presence of moderate or severe encephalopathy
- Infants whose parents/legal guardians have provided consent for enrollment.
NOTE: These inclusion criteria are identical to the NICHD Neonatal Research Network's 2005 Hypothermia study (see links below), except for the time of entry (6-24 hours vs. < 6 hours of age).
Exclusion Criteria
- Any infant with a core body temperature (axilla, rectal) less than 34.0°C for greater than 1 hour
- Presence of a known anomaly or chromosomal aberration
- Birth weight < 1,800 grams
- Infant in extremis
- Infants whose parents/legal guardians or attending physician refuse consent
Data sourced from ClinicalTrials.gov (NCT00614744). 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.