Preemie Hypothermia for Neonatal Encephalopathy

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2022-12-09

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Whole-body Hypothermia

Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 72 hours

Group Type EXPERIMENTAL

Hypothermia

Intervention Type DEVICE

Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 72 hours

Normothermia

Control group (with esophageal temperature at or near 37.0°C) for 72 hours

Group Type PLACEBO_COMPARATOR

Normothermic Control

Intervention Type PROCEDURE

Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours

Interventions

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Hypothermia

Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 72 hours

Intervention Type DEVICE

Normothermic Control

Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

33 Weeks

Maximum Eligible Age

35 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No