Hypoxia Clinical Trial
Official title:
Whole Body Hypothermia for the Treatment of Perinatal Asphyxial Encephalopathy
Hypothesis: Prolonged whole body cooling in term infants with perinatal asphyxial
encephalopathy reduces death and severe neurodevelopmental disability.
This study aims to determine whether whole body cooling to 33-34°C is a safe treatment that
improves survival, without severe neurological or neurodevelopmental impairments at 18
months, of term infants suffering perinatal asphyxial encephalopathy.
This is a multicentre prospective randomised controlled trial to determine whether a
reduction of body temperature by 3-4°C following perinatal asphyxia improves survival
without neurodevelopmental disability.
Full term infants will be randomised within 6 hours of birth to either a control group with
the rectal temperature kept at 37 ± 0.2°C or to whole body cooling with the rectal
temperature kept at 33.5 ± 0.5°C for 72 hours followed by slow rewarming.
The outcome will be assessed at 18 months of age by survival and neurological and
neurodevelopmental testing.
Eligibility criteria:
Term infants less than 6 hours after birth with moderate or severe perinatal asphyxia (a
combination of clinical and EEG criteria).
Exclusion criteria:
Infants expected to be 6 hours of age at the time of randomisation or infants with major
congenital abnormalities.
Intervention:
Intensive care with whole body cooling versus intensive care without whole body cooling
(babies are cooled to 33.5°C for 72 hours)
Main Outcomes:
Death and severe neurodevelopmental impairment at 18 months of age
Secondary Outcomes:
Cerebral thrombosis or haemorrhage, persistent hypotension, pulmonary hypertension, abnormal
coagulation, arrhythmia and sepsis in the neonatal period. Neurological impairments at 18
months
Number of patients required: 236.
On 30th November 2006, when recruitment closed, 325 babies had been recruited.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04498598 -
Structural Modification In Supraglottic Airway Device
|
N/A | |
Completed |
NCT05532670 -
N600X Low Saturation Accuracy Validation
|
||
Enrolling by invitation |
NCT04106401 -
Intravascular Volumes in Hypoxia During Antarctic Confinement
|
N/A | |
Recruiting |
NCT05883137 -
High-flow Nasal Oxygenation for Apnoeic Oxygenation During Intubation of the Critically Ill
|
||
Not yet recruiting |
NCT05817448 -
Hypoxia-induced Autophagy in the Pathogenesis of MAP
|
||
Recruiting |
NCT02661152 -
DAHANCA 30: A Randomized Non-inferiority Trial of Hypoxia-profile Guided Hypoxic Modification of Radiotherapy of HNSCC.
|
Phase 3 | |
Terminated |
NCT02801162 -
Evaluation of Accuracy and Precision of a New Arterial Blood Gas Analysis System Blood in Comparison With the Reference Standard
|
N/A | |
Not yet recruiting |
NCT02201875 -
Intrinsic Periodic Pattern of Breathing
|
N/A | |
Completed |
NCT02943863 -
Regional Ventilation During High Flow Nasal Cannula and Conventional Nasal Cannula in Patients With Hypoxia
|
N/A | |
Completed |
NCT02105298 -
Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study)
|
N/A | |
Completed |
NCT01922401 -
Inverse Ratio Ventilation on Bariatric Operation
|
N/A | |
Active, not recruiting |
NCT01681238 -
Goal-directed Therapy in High-risk Surgery
|
N/A | |
Completed |
NCT01463527 -
Using Capnography to Reduce Hypoxia During Pediatric Sedation
|
N/A | |
Completed |
NCT01507623 -
Value of Capnography During Nurse Administered Propofol Sedation (NAPS)
|
N/A | |
Withdrawn |
NCT00638040 -
The Gene Expression Studies of the Role of Tumor Microenvironments in Tumor Progression
|
N/A | |
Active, not recruiting |
NCT06097754 -
Intermittent Exogenous Ketosis (IEK) at High Altitude
|
N/A | |
Completed |
NCT04589923 -
The VISION-Acute Study
|
||
Completed |
NCT05044585 -
Evaluation of RDS MultiSense® in Desaturation Analysis in Healthy Volunteers
|
N/A | |
Completed |
NCT03659513 -
The Effect of ECMO on the Pharmacokinetics of the Drugs and Their Clinical Efficacy
|
||
Completed |
NCT03221387 -
Sleep and Daytime Use of Humidified Nasal High-flow Oxygen in COPD Outpatients
|
N/A |