Hypoxic-Ischemic Encephalopathy MildTIMENCT04176471
TIME Study: Therapeutic Hypothermia for Infants With Mild Encephalopathy
A study testing Therapeutic Hypothermia and Normothermia in people with Hypoxic-Ischemic Encephalopathy Mild and Neonatal Encephalopathy, run by Stanford University at 5 sites in United States.
Trial summary
The TIME study is a randomized, controlled trial to evaluate impact on early measures of neurodevelopment and the safety profile of therapeutic hypothermia in term neonates with Mild Hypoxic-Ischemic Encephalopathy who are < 6 hours of age. Neurodevelopmental outcome will be assessed at 12-14 months of age. Read more about this study
- Who is it for?
- Ages Up to 6 hours
- Conditions the study is for
- Hypoxic-Ischemic Encephalopathy Mild, Neonatal Encephalopathy
- What is being tested?
- Therapeutic Hypothermia and Normothermia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 May 2020to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates born at ≥ 36 0/7 weeks
- Neonatal signs or contributing factors consistent with an acute peri-partum or intra-partum event (must meet a or b):
- pH ≤ 7.0 or Base deficit ≥ 16 in any umbilical cord or baby specimen at ≤ 1 hr of age OR
- No umbilical cord or baby blood gas at ≤ 1 hr of age OR pH 7.01-7.15 or Base deficit 10-15.9 in any cord or baby specimen at ≤ 1 hr of age AND at least one of the following
- Apgar score at 10 min ≤ 5
- Continued need for resuscitation at 10 min (chest compressions, bag mask ventilation, intubation with positive pressure ventilation)
Show all 10Show fewer
- Acute Perinatal Event: uterine rupture, placental abruption, cord accident (prolapse, rupture, knot or tight nuchal cord), maternal trauma, maternal hemorrhage or cardiorespiratory arrest, fetal exsanguination from either vasa previa or feto-maternal hemorrhage
- Fetal heart rate monitor pattern consistent with acute peripartum or intrapartum event (category III trace: no heart rate variability, presence of recurrent late or variable decelerations, bradycardia, or sinusoidal pattern)
- Evidence of Mild Encephalopathy on Modified Sarnat Exam.
- Presence of at least 2 signs of mild, moderate or severe encephalopathy with no more than 2 moderate or severe findings in the 6 tested categories (level of consciousness, spontaneous activity, posture, tone, neonatal reflexes (suck and moro), and autonomic nervous system
Who cannot join
- Patients < 36 0/7 weeks birthweight < 1800gm; congenital or chromosomal anomaly associated with abnormal neurodevelopment or death; patients with moderate or severe HIE (by Sarnat exam or presence of clinical or electrographic seizures) identified within 6 hours after birth; core body temperature < 34°C for more than 1 hour prior to randomization.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Loma Linda Children's Hospital
Loma Linda, California, 92354
Andrew Hopper, MD
Benioff Children's Hospital Oakland
Oakland, California, 94606
Priscilla Joe, MD
Children's Hospital Orange County
Orange, California, 92868
John Tran, MD
Stanford University
Palo Alto, California, 94034
Sonia Bonifacio, MD
Rady Children's Hospital
San Diego, California, 92123
Jose Honald, MD
About this study
Official title: The TIME STUDY: A Randomized Controlled Trial of Therapeutic Hypothermia for Infants With Mild Encephalopathy in California
The TIME study is a randomized, controlled trial to evaluate impact on early measures of neurodevelopment and the safety profile of therapeutic hypothermia in term neonates with Mild Hypoxic-Ischemic Encephalopathy who are < 6 hours of age. Neurodevelopmental outcome will be assessed at 12-14 months of age. The study will enroll 68 neonates randomized to therapeutic hypothermia or normothermia across 5 centers in California.
Read the detailed description
The TIME study is a multi-center randomized, controlled trial of Therapeutic Hypothermia (TH) (33.5°C ± 0.5° for 72 hours) versus normothermia using targeted temperature management, initiated within 6 hours after birth in term neonates with Mild Hypoxic-Ischemic Encephalopathy (HIE). Mild encephalopathy will be identified using the 6 component modified Sarnat exam as in the Neonatal Research Network of the National Institute of Child Health and Human Development trials of TH for moderate-severe encephalopathy and will be expanded to include features of mild encephalopathy. Eligible subjects must demonstrate ≥ 2 exam abnormalities (mild, moderate, severe) but without evidence of moderate-severe encephalopathy (≥ 3 moderate or severe features). The primary outcome is neurodevelopmental outcome at 12-14 months of age. Secondary outcomes include evaluating the safety profile of therapeutic hypothermia in patients with Mild HIE. Therapeutic hypothermia is well tolerated and did not demonstrate serious safety concerns when evaluated in multiple large studies of neonates with moderate-severe HIE. It is now being applied by some practitioners to neonates with Mild HIE without systematic evidence of benefit or potential harm. This data will be necessary in order to develop and larger trial of efficacy to be determined at 2 years of age.
- Being tested
- Therapeutic Hypothermia, Normothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic HypothermiaOther
Therapeutic hypothermia involves use of a servo-controlled device and blanket to lower the core body temperature by 3°C for 72 hours followed by a period of re-warming in which the temperature is increased by 0.5°C per hour for 6 hours until normothermia is achieved.
NormothermiaOther
Normothermia will be achieved using the same servo-controlled device and blanket to assure normothermia of the control arm. The goal temperature for normothermia is 36.5-37.3°C for 72 hours.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Hypothermia | Experimental | 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. Receives: Other: Therapeutic Hypothermia |
| Normothermia | Active comparator | Normothermia will be achieved using a servo-controlled temperature regulating blanket with the temperature goal of 36.5-37.3°C for 72 hours. Receives: Other: Normothermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA-FS)
Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA-FS) will be assessed at 12-14 months of age. The mean score for a 12 month old normally developing infant is 109 with a standard deviation of 16.5. Higher scores are associated with normal development.
Measured: Assessment takes up to 15 minutes and will be conducted at 12-14 months of age
Alberta Infant Motors Scale (AIMS)
Alberta Infant Motors Scale (AIMS) will be assessed at 12-14 months of age. The AIMS score is determined by assessment of 4 positions and scoring the least and most mature position identified. The score is converted to a percentile for age with those in the 5th to 25th percentile identified as suspicious motor development and those with a score corresponding to < 5th percentile being identified as abnormal motor development.
Measured: Assessment takes up to 15 minutes and will be conducted at 12-14 months of age
Secondary outcomes (17)
Percentage of participants with sinus bradycardia
Investigators will determine the proportion of treated and control subjects who develop sinus bradycardia (HR < 80) during the intervention period (72 hours).
Measured: 72 hours
Percentage of participants thrombocytopenia
Investigators will determine the proportion of treated and control subjects who develop thrombocytopenia (platelet count of < 150 x 109/L) during the intervention period
Measured: 72 hours
Percentage of patients who require intubation and mechanical ventilation
Investigators will determine the proportion of treated and control subjects who require intubation and mechanical ventilation
Measured: 72 hours
Percentage of patients with need for central line
Investigators will determine the proportion of treated and control subjects who have a central line (umbilical or PICC)
Measured: 72 hours
Percentage of participants with Persistent Pulmonary Hypertension (PPHN)
Investigators will determine the proportion of treated and control subjects who have a clinical diagnosis of PPHN or who receive inhaled nitric oxide
Measured: 72 hours
Percentage of participants exposed to sedating or analgesic medications
Investigators will determine the proportion of treated and control subjects who receive narcotics or benzodiazepines
Measured: 72 hours
Percentage of participants exposed to inotropic agents
Investigators will determine the proportion of treated and control subjects who receive inotropic support
Measured: 76 hours
Percentage of participants diagnosed with seizures
Investigators will determine the proportion of treated and control subjects who develop clinical and or electrographic seizures
Measured: During initial hospital stay up to 30 days
Age at initiation of feeds
Investigators will determine the age at which enteral feeds are initiated in treated and control patients
Measured: During initial hospital stay up to 30 days from date of admission
Age at full enteral feeds
Investigators will determine the age at which full enteral feeds or breastfeeding ad lib is achieved in treated and control patients
Measured: During initial hospital stay and up to 30 days from date of admission
Percentage of participants who require feeding assistance at discharge
Investigators will determine the proportion of treated and control patients who require feeding support at discharge (NG tube or G-Tube feeds)
Measured: At time of discharge from hospital, up to 30 days from admission
Percentage of participants with fat necrosis and hypercalcemia
Investigators will determine the proportion of treated and control patients who have a diagnosis of fat necrosis and hypercalcemia
Measured: From study entry to day of hospital discharge, up to 30 days from admission
Percentage of participants discharged on anti-convulsant medications
Investigators will determine the proportion of treated and control patients who are discharged home on anti-convulsant medications
Measured: At time of discharge from hospital, up to 30 days from admission
Count of participants with brain injury on MRI
Investigators will determine the number of treated and control patients who have brain injury on MRI
Measured: At time of discharge from hospital, up to 30 days from admission
Length of Hospital Stay
Investigators will determine the length of hospital stay for treated and control patients
Measured: At time of discharge from hospital, up to 30 days from admission
Percentage of participants breastfeeding at discharge
Investigators will determine the proportion of treated and control patients who are breastfeeding at discharge
Measured: At time of discharge from hospital, up to 30 days from admission
Percentage of participants with death and/or hospice at discharge
Investigators will determine the proportion of treated and control patients who die or are discharged home on hospice
Measured: At time of discharge from hospital, up to 30 days from admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start1 May 2020 (estimated)
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hypoxic-Ischemic Encephalopathy MildStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 68 neonates with mild HIE will be enrolled and randomized to therapeutic hypothermia (33.5°C ± 0.5°C for 72 hours plus 6 hours of rewarming) or normothermia (36.5-37.3°C for 72 hours ) with targeted temperature management. Each treatment group will have 34 patients. Participants randomized to normothermia who develop signs of moderate-severe HIE in the first 24 hours after birth will be crossed over to the treatment arm, as therapeutic hypothermia is the standard of care treatment for neonates with moderate-severe HIE.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Thrasher Research Fund
- Responsible party
- Principal investigator, Sonia Bonifacio, Stanford University
- Investigators
- Sonia Bonifacio, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04176471
- Sponsor's protocol ID
- 53274
- Acronym
- TIME
- Status last verified
- Mar 2020
- First submitted
- 14 Nov 2019
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akula VP, Sriram A, Xu S, Walsh E, Van Meurs K, Cranshaw M, Kuzniewicz MW. Adverse short- and long-term outcomes among infants with mild neonatal encephalopathy. Pediatr Res. 2023 Sep;94(3):1003-1010. doi: 10.1038/s41390-022-02249-8. Epub 2022 Aug 23.
PubMed 35999380Blecharczyk E, Lee L, Birnie K, Gupta A, Davis A, Van Meurs K, Bonifacio S, Frymoyer A. Standardized Evaluation of Cord Gases in Neonates at Risk for Hypoxic Ischemic Encephalopathy. Hosp Pediatr. 2022 Jan 1;12(1):29-37. doi: 10.1542/hpeds.2021-006135.
PubMed 34854918
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The TIME STUDY: A Randomized Controlled Trial of Therapeutic Hypothermia for Infants With Mild Encephalopathy in California
- ClinicalTrials.gov ID
- NCT04176471
- Acronym / sponsor ID
- TIME / 53274
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Thrasher Research Fund
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 25 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The TIME study is a randomized, controlled trial to evaluate impact on early measures of neurodevelopment and the safety profile of therapeutic hypothermia in term neonates with Mild Hypoxic-Ischemic Encephalopathy who are < 6 hours of age. Neurodevelopmental outcome will be assessed at 12-14 months of age. The study will enroll 68 neonates randomized to therapeutic hypothermia or normothermia across 5 centers in California.
Detailed description
The TIME study is a multi-center randomized, controlled trial of Therapeutic Hypothermia (TH) (33.5°C ± 0.5° for 72 hours) versus normothermia using targeted temperature management, initiated within 6 hours after birth in term neonates with Mild Hypoxic-Ischemic Encephalopathy (HIE). Mild encephalopathy will be identified using the 6 component modified Sarnat exam as in the Neonatal Research Network of the National Institute of Child Health and Human Development trials of TH for moderate-severe encephalopathy and will be expanded to include features of mild encephalopathy. Eligible subjects must demonstrate ≥ 2 exam abnormalities (mild, moderate, severe) but without evidence of moderate-severe encephalopathy (≥ 3 moderate or severe features). The primary outcome is neurodevelopmental outcome at 12-14 months of age. Secondary outcomes include evaluating the safety profile of therapeutic hypothermia in patients with Mild HIE. Therapeutic hypothermia is well tolerated and did not demonstrate serious safety concerns when evaluated in multiple large studies of neonates with moderate-severe HIE. It is now being applied by some practitioners to neonates with Mild HIE without systematic evidence of benefit or potential harm. This data will be necessary in order to develop and larger trial of efficacy to be determined at 2 years of age.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A total of 68 neonates with mild HIE will be enrolled and randomized to therapeutic hypothermia (33.5°C ± 0.5°C for 72 hours plus 6 hours of rewarming) or normothermia (36.5-37.3°C for 72 hours ) with targeted temperature management. Each treatment group will have 34 patients. Participants randomized to normothermia who develop signs of moderate-severe HIE in the first 24 hours after birth will be crossed over to the treatment arm, as therapeutic hypothermia is the standard of care treatment for neonates with moderate-severe HIE.
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Hypothermia | Experimental | Other: Therapeutic HypothermiaTherapeutic 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. |
| Normothermia | Active comparator | Other: NormothermiaNormothermia will be achieved using a servo-controlled temperature regulating blanket with the temperature goal of 36.5-37.3°C for 72 hours. |
Who may qualify
- Ages
- Up to 6 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Neonates born at ≥ 36 0/7 weeks
- Neonatal signs or contributing factors consistent with an acute peri-partum or intra-partum event (must meet a or b):
- Evidence of Mild Encephalopathy on Modified Sarnat Exam.
Key exclusion criteria (1 listed)
- Patients < 36 0/7 weeks birthweight < 1800gm; congenital or chromosomal anomaly associated with abnormal neurodevelopment or death; patients with moderate or severe HIE (by Sarnat exam or presence of clinical or electrographic seizures) identified within 6 hours after birth; core body temperature < 34°C for more than 1 hour prior to randomization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic HypothermiaTherapeutic hypothermia involves use of a servo-controlled device and blanket to lower the core body temperature by 3°C for 72 hours followed by a period of re-warming in which the temperature is increased by 0.5°C per hour for 6 hours until normothermia is achieved. | Other | Therapeutic Hypothermia |
| NormothermiaNormothermia will be achieved using the same servo-controlled device and blanket to assure normothermia of the control arm. The goal temperature for normothermia is 36.5-37.3°C for 72 hours. | Other | Normothermia |
Primary outcome
Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA-FS)
Time frame: Assessment takes up to 15 minutes and will be conducted at 12-14 months of age
Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA-FS) will be assessed at 12-14 months of age. The mean score for a 12 month old normally developing infant is 109 with a standard deviation of 16.5. Higher scores are associated with normal development.
Alberta Infant Motors Scale (AIMS)
Time frame: Assessment takes up to 15 minutes and will be conducted at 12-14 months of age
Alberta Infant Motors Scale (AIMS) will be assessed at 12-14 months of age. The AIMS score is determined by assessment of 4 positions and scoring the least and most mature position identified. The score is converted to a percentile for age with those in the 5th to 25th percentile identified as suspicious motor development and those with a score corresponding to < 5th percentile being identified as abnormal motor development.
17 secondary outcomes
Percentage of participants with sinus bradycardia
Time frame: 72 hours
Percentage of participants thrombocytopenia
Time frame: 72 hours
Percentage of patients who require intubation and mechanical ventilation
Time frame: 72 hours
Percentage of patients with need for central line
Time frame: 72 hours
Percentage of participants with Persistent Pulmonary Hypertension (PPHN)
Time frame: 72 hours
Percentage of participants exposed to sedating or analgesic medications
Time frame: 72 hours
Percentage of participants exposed to inotropic agents
Time frame: 76 hours
Percentage of participants diagnosed with seizures
Time frame: During initial hospital stay up to 30 days
Age at initiation of feeds
Time frame: During initial hospital stay up to 30 days from date of admission
Age at full enteral feeds
Time frame: During initial hospital stay and up to 30 days from date of admission
Percentage of participants who require feeding assistance at discharge
Time frame: At time of discharge from hospital, up to 30 days from admission
Percentage of participants with fat necrosis and hypercalcemia
Time frame: From study entry to day of hospital discharge, up to 30 days from admission
Percentage of participants discharged on anti-convulsant medications
Time frame: At time of discharge from hospital, up to 30 days from admission
Count of participants with brain injury on MRI
Time frame: At time of discharge from hospital, up to 30 days from admission
Length of Hospital Stay
Time frame: At time of discharge from hospital, up to 30 days from admission
Percentage of participants breastfeeding at discharge
Time frame: At time of discharge from hospital, up to 30 days from admission
Percentage of participants with death and/or hospice at discharge
Time frame: At time of discharge from hospital, up to 30 days from admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Derived from this study: PubMed 35999380Akula VP, Sriram A, Xu S, Walsh E, Van Meurs K, Cranshaw M, Kuzniewicz MW. Adverse short- and long-term outcomes among infants with mild neonatal encephalopathy. Pediatr Res. 2023 Sep;94(3):1003-1010. doi: 10.1038/s41390-022-02249-8. Epub 2022 Aug 23.
- Derived from this study: PubMed 34854918Blecharczyk E, Lee L, Birnie K, Gupta A, Davis A, Van Meurs K, Bonifacio S, Frymoyer A. Standardized Evaluation of Cord Gases in Neonates at Risk for Hypoxic Ischemic Encephalopathy. Hosp Pediatr. 2022 Jan 1;12(1):29-37. doi: 10.1542/hpeds.2021-006135.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonia Bonifacio, MD principal investigator
Stanford University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Hypothermia and Normothermia in people with Hypoxic-Ischemic Encephalopathy Mild and Neonatal Encephalopathy, run by Stanford University at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sonia L Bonifacio, MD (650-723-5711, soniab1@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA-FS) (time frame: Assessment takes up to 15 minutes and will be conducted at 12-14 months of age). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04176471, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.