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Therapeutic Hypothermia for Neonatal Encephalopathy (TIME Trial)
N/A
Waitlist Available
Led By Sonia Bonifacio, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Neonatal signs or contributing factors consistent with an acute peri-partum or intra-partum event
Continued need for resuscitation at 10 min (chest compressions, bag mask ventilation, intubation with positive pressure ventilation)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
TIME Trial Summary
This trial will study the effects of therapeutic hypothermia on neurodevelopment in term neonates with Mild Hypoxic-Ischemic Encephalopathy. 68 neonates will be enrolled and randomly assigned to either the therapeutic hypothermia group or the normothermia group. Neurodevelopmental outcomes will be assessed at 12-14 months of age.
Who is the study for?
The TIME Study is for newborns with Mild Hypoxic-Ischemic Encephalopathy, born at or after 36 weeks of pregnancy. They must show signs consistent with an acute event around birth and require resuscitation efforts at 10 minutes old. Babies with genetic issues, born before 36 weeks, weighing less than 1800 grams, or having moderate/severe HIE are excluded.Check my eligibility
What is being tested?
This study tests the effects of cooling therapy (therapeutic hypothermia) versus normal temperature maintenance (normothermia) on brain health in term neonates with mild brain injury due to oxygen deprivation. Outcomes will be measured by neurodevelopmental progress at about one year old.See study design
What are the potential side effects?
Potential side effects may include risks associated with managing body temperature in infants such as abnormal heart rate or breathing patterns, changes in blood pressure, altered blood sugar levels, and potential impacts on infection risk.
TIME Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My newborn shows signs of distress from birth complications.
Select...
I needed life-saving measures like chest compressions or a breathing tube 10 minutes after resuscitation.
Select...
I experienced a serious complication during childbirth.
TIME Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Alberta Infant Motors Scale (AIMS)
Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA-FS)
Secondary outcome measures
Age at full enteral feeds
Age at initiation of feeds
Count of participants with brain injury on MRI
+14 moreOther outcome measures
Age at Initiation of Treatment
Age at Randomization
Percentage of participants with disability at 2 years of age
Side effects data
From 2014 Phase 3 trial • 295 Patients • NCT0087864417%
Hypotension
15%
Hypoxic encephalopathy
14%
Hypokalemia
14%
Diabetes insipidus
13%
Anemia
13%
Hypertension
12%
Atelectasis
12%
Hyperglycemia
12%
Seizures
11%
Cerebral edema
10%
Seizure
10%
Anoxic brain damage
9%
Hypoglycemia
9%
Sputum culture positive
9%
Hypernatremia
8%
Pleural effusion
8%
Hypocalcemia
7%
Fever
6%
Coagulopathy
6%
Hyponatremia
6%
Oxygen saturation decreased
6%
Cardiac arrest
6%
Urine output decreased
5%
Pancreatitis
5%
Hyperkalemia
5%
Tachycardia
4%
Hypophosphatemia
4%
Pulmonary edema
4%
Hypomagnesemia
4%
Leukocytosis
4%
Rhinovirus infection
4%
Thalamic syndrome
4%
Respiratory infection
4%
Bradycardia
4%
Shivering
4%
Urine culture positive
4%
Lactate dehydrogenase increased
4%
Pneumomediastinum
4%
Pneumothorax
4%
Blood culture positive
4%
Agitation
4%
Brain herniation
4%
Potassium decreased
3%
Ischemia
3%
AST increased
3%
Urine output increased
3%
Tachypnea
3%
Hypoxic brain damage
3%
Low blood pressure
3%
Hypothermia
3%
Abnormal EEG
3%
Edema
3%
EEG abnormal
3%
Haemoglobin low
3%
Hyperchloremia
3%
Respiratory distress
3%
Skin breakdown
2%
Escherichia urinary tract infection
2%
Ventricular tachycardia
2%
Metabolic acidosis
2%
Anasarca
2%
Base excess decreased
2%
Fluid overload
2%
PO2 decreased
2%
Troponin increased
2%
Bacterial tracheitis
2%
Hypoxemia
2%
Retinal hemorrhage
2%
Diarrhea
2%
Emesis
2%
Pneumonia
2%
Sinusitis
2%
LDH increased
2%
Dysautonomia
2%
Status epilepticus
2%
Posturing
2%
Cardiac failure
2%
Acidosis
2%
Cerebral salt-wasting syndrome
1%
Diaphragmatic hernia
1%
Hemodynamic instability
1%
Anisocoria
1%
Distended abdomen
1%
Edema of extremities
1%
Pseudomonas aeruginosa infection NOS
1%
Urinary tract infection bacterial
1%
CRP increased
1%
Collapse of lung
1%
Escherichia coli infection
1%
Respiratory syncytial virus infection
1%
Aspartate aminotransferase increased
1%
Streptococcus viridans group infection
1%
Pneumatosis intestinalis
1%
Serous otitis media (glue ear)
1%
Sinus tachycardia
1%
Adrenal insufficiency
1%
Hyperthermia
1%
Septic shock
1%
Urine candida
1%
Hematocrit low
1%
Hemoglobin decreased
1%
INR decreased
1%
Edema of lower extremities
1%
Multi-organ disorder
1%
Hepatomegaly
1%
Decreased hemoglobin
1%
Staphylococcus aureus pneumonia
1%
APTT decreased
1%
PCO2 increased
1%
CPK increase
1%
Decreased ventricular afterload
1%
WBC increased
1%
Cerebral ischemia
1%
Renal function aggravated
1%
Polyuria
1%
Pharyngeal edema
1%
Red man syndrome
1%
Aspiration
1%
Emphysema
1%
Coughing
1%
Wheezing
1%
Shock vascular
1%
Loss of gag reflex
1%
Candida albicans infection
1%
Tracheitis
1%
Multi-organ failure
1%
Sepsis
1%
Bloody airway discharge
1%
Asthma
1%
Face oedema
1%
Stools watery
1%
Swallowing disorder
1%
Extravasation
1%
Liver failure
1%
Hyperbilirubinemia
1%
Gram-positive cocci infection
1%
Renal injury
1%
Rib fracture
1%
Tibia fracture
1%
Spinal epidural hematoma
1%
Arterial blood pH decreased
1%
B-type natriuretic peptide
1%
BUN increased
1%
Sodium low
1%
Hypochloremia
1%
Hypoproteinemia
1%
Clonus
1%
Unspecified disease of respiratory system
1%
Hypercarbia
1%
Poor peripheral perfusion
1%
Dilatation pupillary
1%
Ischemia cerebral
1%
DIC
1%
Acute renal failure
1%
Myocardial depression
1%
Premature ventricular contractions
1%
GI bleed
1%
Generalized edema
1%
Bacteria blood identified
1%
Transaminitis
1%
Encephalopathy
1%
Hematocrit decreased
1%
Cerebral infarction
1%
Respiratory insufficiency
1%
Hypertonia
1%
Oliguria
1%
Memory deficit
1%
Renal failure
1%
Hypercapnia
1%
Shock
1%
Jugular vein thrombosis
1%
Phlebitis
1%
DVT
1%
HIE
1%
CO2 total abnormal
1%
Glucose increased
1%
Glucose urine present
1%
Atrial tachycardia
1%
Heart rate increased
1%
Bowel ischemia
1%
Gastroesophageal reflux
1%
ARDS
1%
Staphylococcal infection
1%
Chloride low
1%
Creatinine increased
1%
Leukopenia
1%
Hypoalbuminemia
1%
Blood osmolarity increased
1%
Blood pH abnormal
1%
Blood phosphorus increased
1%
IIIrd nerve palsy
1%
Ischemic stroke
1%
Gastrointestinal mucosal sloughing
1%
Gum erosion
1%
Pancreatitis aggravated
1%
Pneumoperitoneum
1%
Saliva secretion excessive
1%
Vomiting
1%
Ionized calcium decreased
1%
Swelling of legs
1%
Acute liver injury
1%
Bilateral pneumonia
1%
Hypoxia
1%
Catheter site infection
1%
Central line infection
1%
Pulmonary edema recurrent
1%
Pulmonary hypertension
1%
Pulmonary vascular disorder
1%
Respiratory acidosis
1%
Respiratory tract infection bacterial
1%
Septicemia
1%
Muscle spasms
1%
Acquired tracheobronchomalacia
1%
Apnea
1%
Aspiration pneumonia
1%
Clotting
1%
Cardiac failure aggravated
1%
Multi organ failure
1%
Pyrexia
1%
Klebsiella pneumonia
1%
Klebsiella pneumoniae infection
1%
Infection pseudomonas aeruginosa
1%
Neurological status deterioration
1%
UTI
1%
Urinary tract infection
1%
Pulmonary hemorrhage
1%
Disseminated intravascular coagulation
1%
Neutropenia
1%
Thrombocytopenia
1%
Subdural hemorrhage
1%
Bundle branch block
1%
Cardiomegaly
1%
Fibrosis myocardial
1%
Junctional rhythm
1%
Left ventricular dysfunction
1%
Left ventricular systolic dysfunction
1%
Dilated pupils
1%
Fixed dilated pupils
1%
Gaze palsy
1%
Pupillary reaction slow
1%
Ascites
1%
Constipation
1%
Gastrointestinal bleeding
1%
Nausea
1%
Catheter site bleeding
1%
Gallbladder edema
1%
Clostridium difficile infection
1%
Haemophilus influenzae infection
1%
Lung infection
1%
Septicemia due to Escherichia coli (E. coli)
1%
Soft tissue infection
1%
Staphylococcal pneumonia
1%
Femur fracture
1%
Fracture of upper end or unspecified part of radius and ulna, closed
1%
Fractured cervical spine
1%
Humerus fracture
1%
Iatrogenic pneumothorax
1%
Ligament injury
1%
ALT increased
1%
Amylase high
1%
Amylase increased
1%
Blood bicarbonate decreased
1%
Blood bicarbonate low
1%
Blood pressure increased
1%
Creatine phosphokinase increased
1%
Drug level above therapeutic
1%
Elevated liver enzymes
1%
Fecal occult blood
1%
Function pulmonary decreased
1%
Gastric pH decreased
1%
Glucose decreased
1%
Glucose high
1%
INR increased
1%
Increased blood pressure
1%
Lactate increased
1%
Lipase increased
1%
Magnesium decreased
1%
Methicillin-resistant Staphylococcus aureus test positive
1%
Neurological examination abnormal
1%
PCO2 abnormal
1%
PTT prolonged
1%
Phosphorus low
1%
Sodium increased
1%
Alkalosis
1%
Hyperammonemia
1%
Hyperamylasemia
1%
Hyperlipasemia
1%
Hypermagnesemia
1%
Hyperphosphatemia
1%
Metabolic alkalosis
1%
Autonomic dysfunction
1%
Autonomic instability
1%
Cerebral hematoma
1%
Increased intracranial pressure
1%
Myoclonic seizure NOS
1%
Myoclonus
1%
Shaking
1%
Tremor
1%
Anuria
1%
Interstitial lung disease
1%
Labored breathing
1%
Rash
1%
Aortic thrombosis
1%
Blood pressure fluctuation
1%
Clot blood
1%
Coldness of lower extremities
1%
DVT of legs
1%
Deep vein thrombosis leg
1%
Thrombosis leg
1%
Band neutrophil count increased
1%
Lung injury
1%
Multiple organ failure
1%
Anoxic encephalopathy
1%
Intracranial hemorrhage
1%
Respiratory failure
1%
Respiratory failure aggravated
1%
Skin ulcer
1%
PVC's
1%
Retinopathy hemorrhagic
1%
Bacterial infection due to staphylococcus aureus
1%
Enterovirus infection
1%
Ventilator associated pneumonia
1%
Yeast infection
1%
PT increased
1%
Acidosis metabolic
1%
Feeding difficulties and mismanagement
1%
Azotemia
1%
Urinary retention
1%
Breathing abnormally shallow
1%
Bronchial wall thickening
1%
Chronic respiratory failure
1%
Respiratory alkalosis
1%
Wheezing aggravated
1%
Blisters
1%
Diaper rash
1%
Redness
1%
Subcutaneous emphysema
1%
Ulcer skin
1%
Acute hypotension
1%
Venous thrombosis
1%
Platelet count increased
1%
Swelling of limb
1%
Lactate high
1%
Urine ketone body present
1%
Carbon monoxide poisoning
1%
Infusion site erythema
1%
Hypotonia
1%
Potassium increased
1%
Hypercholesterolemia
1%
Cerebral infarct
1%
Hypotensive
100%
80%
60%
40%
20%
0%
Study treatment Arm
Therapeutic Normothermia
Therapeutic Hypothermia
TIME Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Therapeutic HypothermiaExperimental Treatment1 Intervention
Therapeutic hypothermia will be achieved using a servo-controlled temperature regulating blanket that is approved for use in neonates and is currently used for the treatment of neonates with moderate-severe HIE. The goal target temperature is 33.5°C ± 0.5°C for 72 hours and the subject will then be rewarmed at a rate of 0.5°C per hour to a goal of 36.5°C.
Group II: NormothermiaActive Control1 Intervention
Normothermia will be achieved using a servo-controlled temperature regulating blanket with the temperature goal of 36.5-37.3°C for 72 hours.
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,386 Previous Clinical Trials
17,333,940 Total Patients Enrolled
Thrasher Research FundOTHER
132 Previous Clinical Trials
94,306 Total Patients Enrolled
Sonia Bonifacio, MDPrincipal InvestigatorStanford University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your body temperature has been lower than 34°C for more than 1 hour before the study starts.I have a genetic condition affecting my brain development or causing risk of death.The baby's heart rate pattern shows signs of distress during labor or delivery.My baby was born at or after 36 weeks of pregnancy.Patients who are less than 36 weeks pregnant.My newborn shows signs of distress from birth complications.My birthweight was under 1800 grams.I show at least 2 signs of brain function issues but not more than 2 severe ones in specific tests.I needed life-saving measures like chest compressions or a breathing tube 10 minutes after resuscitation.I experienced a serious complication during childbirth.My baby was diagnosed with moderate or severe brain injury within 6 hours of birth.The baby's Apgar score is less than or equal to 5 at 10 minutes after birth.Signs of mild brain problems on a special exam.
Research Study Groups:
This trial has the following groups:- Group 1: Therapeutic Hypothermia
- Group 2: Normothermia
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the primary objectives of this research endeavor?
"The primary objective of this research, which will be conducted over a 15-minute period when participants are between 12 and 14 months old, is to evaluate their adaptive and functional skills using the Warner Initial Developmental Evaluation (WIDEA-FS). Secondary goals involve determining the number of patients with sinus bradycardia (heart rate below 80), those who require sedatives or analgesics, as well as those suffering from Persistent Pulmonary hypertension."
Answered by AI
How many medical centers are currently conducting this research trial?
"At the present time, this clinical trial is accepting participants at 5 medical centres. These sites are found in Oakland, Orange and Loma Linda as well as 2 other cities. To reduce travel demands it is prudent to select a nearby site for enrollment if possible."
Answered by AI
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