Acute Kidney InjuryPhase 1NCT05295784
PK and Safety of Caffeine in Neonates With Hypoxic Ischemic Encephalopathy Receiving Therapeutic Hypothermia
A Phase 1 study testing Caffeine citrate in people with Acute Kidney Injury and Hypoxic-Ischemic Encephalopathy, run by University of Arkansas at 2 sites in United States.
Trial summary
A phase 1 study investigating the tolerability and pharmacokinetics of caffeine citrate in neonates with hypoxic ischemic encephalopathy receiving therapeutic hypothermia. This study is an essential first step to develop caffeine as a kidney protective medication in this in this vulnerable group of newborns. Read more about this study
- Who is it for?
- Ages 0 to 24 hours
- Conditions the study is for
- Acute Kidney Injury, Hypoxic-Ischemic Encephalopathy, Caffeine
- What is being tested?
- Caffeine citrate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 May 2024to 8 May 2024
- Phase
- Phase 1
- 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 0 to 24 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborns ≥ 35 weeks GA
- Admitted to the ACH NICU less than 24 hours of life
- Receiving active or passive TH or whole-body cooling at 12 hours of life to treat hypoxic ischemic encephalopathy per institutional criteria based on National Institute of Child Health and Human Development criteria
Who cannot join
- Genetic or congenital condition that affects renal function (e.g., congenital anomalies of the kidney and urinary tract (CAKUT), complex congenital heart disease)
- Diminished capacity or autonomy of the neonate's parents that prevents their ability to give informed consent
- Theophylline, aminophylline, or caffeine exposure prior to enrollment
- Status epilepticus as defined by:
- A seizure lasting longer than 30 minutes
- Use of a continuous infusion of antiepileptic medication (i.e., midazolam)
- The use of 3 or more antiepileptic medications for the indications of intractable seizures
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: Pharmacokinetics (PK) and Safety of Caffeine in Neonates With Hypoxic Ischemic Encephalopathy Receiving Therapeutic Hypothermia
A phase 1 study investigating the tolerability and pharmacokinetics of caffeine citrate in neonates with hypoxic ischemic encephalopathy receiving therapeutic hypothermia. This study is an essential first step to develop caffeine as a kidney protective medication in this in this vulnerable group of newborns.
Read the detailed description
Neonatal acute kidney injury (AKI) is an unfortunate comorbidity in neonates with hypoxic ischemic encephalopathy (HIE) which is brain injury due to a lack of blood flow and oxygen delivery to a neonate around the time of delivery. Neonatal AKI increases the risk of death by 4 fold. AKI in neonates with HIE is associated with brain injury on brain MRI and worse neurodevelopmental outcomes at 2 years. Despite the increases in death and morbidity associated with AKI, limited therapeutic interventions currently exist.
Caffeine is a promising medication for kidney protection in neonates at high risk for AKI. Three retrospective studies in premature neonates identified a reduction in AKI in neonates exposed to caffeine. Theophylline, which is in the same drug class as caffeine, has been shown to improve urine output and decrease AKI in neonates with HIE. Limited centers worldwide utilize theophylline in neonates with HIE due to its side effects. Caffeine is a well-tolerated and is extensively utilized in neonatal intensive care units (NICUs) in the premature population for prevention of chronic lung disease and for apnea of prematurity (or immature breathing patterns). Therefore, dosing guidelines are well established for preterm neonates and neonatologists are comfortable administering the drug.
Specific Aim 1: Determine the pharmacokinetics (how an organism affects a drug) of caffeine in neonates ≥ 35 weeks GA with HIE receiving therapeutic hypothermia.
Specific Aim 2: Assess the preliminary safety and tolerability of caffeine in neonates with HIE receiving hypothermia including any impact on seizure burden.
Specific Aim 1: Characterize acute kidney injury (AKI) in neonates with HIE receiving therapeutic hypothermia with caffeine exposure using serum creatinine (SCr), urine output, renal near infrared spectroscopy (NIRS), and urinary biomarkers.
General Experimental Approach:
A total of 18 neonates will be enrolled over approximately 18 months. Each neonate will receive a single dose of caffeine in the first 24 hours of life. The first six neonates will receive low dose (5 mg/kg), the next six neonates will receive a medium dose (15 mg/kg), and the next six neonates will receive high dose or (25 mg/kg).
Demographic data (birthdate, sex, ethnicity, race, gestational age) and clinical data (perinatal birth history, other diagnosis) will be collected from the electronic medical record input into a secure REDCap database created uniquely for this study. Laboratory (serum creatinine) and imaging (head ultrasound and brain MRIs) results will also be recorded.
Blood samples will be obtained from the newborns to monitor the caffeine blood levels. Urine samples will be analyzed for biomarkers that detect kidney damage. Data on seizures and medications will be monitored closely. Blood flow and oxygen levels in the kidney will be monitored with a non-invasive technology called near infrared spectroscopy or NIRS. Data will be collected on urine output and blood creatinine levels to determine which newborns have acute kidney injury.
In conclusion, this study will investigate the drug levels in the blood of caffeine in neonates with HIE receiving therapeutic hypothermia. Safety will also be monitored obtained. The investigators anticipate caffeine is a safe and effective therapy. This study is an essential first step to develop caffeine as a kidney protective medication in this in this vulnerable group of newborns.
- Being tested
- Caffeine citrate
- Medical subject headings
- Acute Kidney Injury, Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caffeine citrateDrug
Also called Cafcit
A single dose of intravenous caffeine citrate will be administered to neonates with hypoxic ischemic encephalopathy to determine the pharmacokinetics and tolerability.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Low dose caffeine | Active comparator | Each neonate will receive a single dose of caffeine citrate in the first 24 hours of life. Arm 1 neonates will receive low dose intravenous caffeine citrate (5 mg/kg). Receives: Drug: Caffeine citrate |
| Arm 2: Medium dose caffeine | Active comparator | Each neonate will receive a single dose of caffeine citrate in the first 24 hours of life. Arm 2 neonates will receive medium dose intravenous caffeine citrate (15 mg/kg). Receives: Drug: Caffeine citrate |
| Arm 3: High dose caffeine | Active comparator | Each neonate will receive a single dose of caffeine citrate in the first 24 hours of life. Arm 3 neonates will receive high dose intravenous caffeine citrate (25 mg/kg). Receives: Drug: Caffeine citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance of caffeine
Clearance (mL h-1 kg-1)
Measured: 1 week
Volume of distribution of caffeine
Volume of distribution (ml/kg)
Measured: 1 week
Peak plasma concentration (Cmax) of caffeine
Peak plasma concentration (Cmax) (ng/mL)
Measured: 1 week
Area under the plasma concentration-time curve of caffeine
Area under the plasma concentration-time curve from 0 to infinity (AUC0-INF) (mg*h/L)
Measured: 1 week
Seizure incidence
Number of neonates who developed seizures based on continuous video electroencephalogram (VEEG) data
Measured: 2 weeks
Seizure burden
Electrographic seizures (in minutes per hour) based on continuous video electroencephalogram (VEEG) data
Measured: 2 weeks
Secondary outcomes (5)
Acute kidney injury
AKI incidence utilizing KDIGO criteria based on urine output and SCr.
Measured: 10 days
Renal near infrared spectroscopy (NIRS)
Investigate changes in renal NIRS values during the therapeutic hypothermia and rewarming period.
Measured: 5 days
Urine neutrophil gelatinase-associated lipocalin (NGAL) (ng/mL)
Urine samples will be collected at 24, 48 and 72 hours after birth. Urine will be analyzed for NGAL.
Measured: 3 days
Urine kidney injury molecule-1 (KIM-1) (pg/mL)
Urine samples will be collected at 24, 48 and 72 hours after birth. Urine will be analyzed for KIM-1.
Measured: 3 days
Urine interleukin-18 (IL-18) (pg/mL)
Urine samples will be collected at 24, 48 and 72 hours after birth. Urine will be analyzed for IL-18.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start8 May 2024
- Primary completion8 May 2024
- Study completion8 May 2024
Why it stopped: Data no longer support this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Each neonate will receive a single dose of caffeine citrate in the first 24 hours of life. The first six neonates will receive low dose (5 mg/kg), the next six neonates will receive a medium dose (15 mg/kg), and the next six neonates will receive high dose or (25 mg/kg).
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Rumpel, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05295784
- Sponsor's protocol ID
- 260845
- Status last verified
- Apr 2024
- First submitted
- 21 Feb 2022
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rumpel J, Spray BJ, Chock VY, Kirkley MJ, Slagle CL, Frymoyer A, Cho SH, Gist KM, Blaszak R, Poindexter B, Courtney SE. Urine Biomarkers for the Assessment of Acute Kidney Injury in Neonates with Hypoxic Ischemic Encephalopathy Receiving Therapeutic Hypothermia. J Pediatr. 2022 Feb;241:133-140.e3. doi: 10.1016/j.jpeds.2021.08.090. Epub 2021 Sep 20.
PubMed 34547334Selewski DT, Jordan BK, Askenazi DJ, Dechert RE, Sarkar S. Acute kidney injury in asphyxiated newborns treated with therapeutic hypothermia. J Pediatr. 2013 Apr;162(4):725-729.e1. doi: 10.1016/j.jpeds.2012.10.002. Epub 2012 Nov 10.
PubMed 23149172Kirkley MJ, Boohaker L, Griffin R, Soranno DE, Gien J, Askenazi D, Gist KM; Neonatal Kidney Collaborative (NKC). Acute kidney injury in neonatal encephalopathy: an evaluation of the AWAKEN database. Pediatr Nephrol. 2019 Jan;34(1):169-176. doi: 10.1007/s00467-018-4068-2. Epub 2018 Aug 28.
PubMed 30155763Jetton JG, Boohaker LJ, Sethi SK, Wazir S, Rohatgi S, Soranno DE, Chishti AS, Woroniecki R, Mammen C, Swanson JR, Sridhar S, Wong CS, Kupferman JC, Griffin RL, Askenazi DJ; Neonatal Kidney Collaborative (NKC). Incidence and outcomes of neonatal acute kidney injury (AWAKEN): a multicentre, multinational, observational cohort study. Lancet Child Adolesc Health. 2017 Nov;1(3):184-194. doi: 10.1016/S2352-4642(17)30069-X.
PubMed 29732396Cavallin F, Rubin G, Vidal E, Cainelli E, Bonadies L, Suppiej A, Trevisanuto D. Prognostic role of acute kidney injury on long-term outcome in infants with hypoxic-ischemic encephalopathy. Pediatr Nephrol. 2020 Mar;35(3):477-483. doi: 10.1007/s00467-019-04406-4. Epub 2019 Dec 11.
PubMed 31828471Bhatt GC, Gogia P, Bitzan M, Das RR. Theophylline and aminophylline for prevention of acute kidney injury in neonates and children: a systematic review. Arch Dis Child. 2019 Jul;104(7):670-679. doi: 10.1136/archdischild-2018-315805. Epub 2019 Feb 23.
PubMed 30798259Chock VY, Cho SH, Frymoyer A. Aminophylline for renal protection in neonatal hypoxic-ischemic encephalopathy in the era of therapeutic hypothermia. Pediatr Res. 2021 Mar;89(4):974-980. doi: 10.1038/s41390-020-0999-y. Epub 2020 Jun 5.
PubMed 32503030Harer MW, Askenazi DJ, Boohaker LJ, Carmody JB, Griffin RL, Guillet R, Selewski DT, Swanson JR, Charlton JR; Neonatal Kidney Collaborative (NKC). Association Between Early Caffeine Citrate Administration and Risk of Acute Kidney Injury in Preterm Neonates: Results From the AWAKEN Study. JAMA Pediatr. 2018 Jun 4;172(6):e180322. doi: 10.1001/jamapediatrics.2018.0322. Epub 2018 Jun 4.
PubMed 29610830Aviles-Otero N, Kumar R, Khalsa DD, Green G, Carmody JB. Caffeine exposure and acute kidney injury in premature infants with necrotizing enterocolitis and spontaneous intestinal perforation. Pediatr Nephrol. 2019 Apr;34(4):729-736. doi: 10.1007/s00467-018-4140-y. Epub 2018 Nov 10.
PubMed 30415418Carmody JB, Harer MW, Denotti AR, Swanson JR, Charlton JR. Caffeine Exposure and Risk of Acute Kidney Injury in a Retrospective Cohort of Very Low Birth Weight Neonates. J Pediatr. 2016 May;172:63-68.e1. doi: 10.1016/j.jpeds.2016.01.051. Epub 2016 Feb 18.
PubMed 26898806AlGadeeb K, Qaraqei M, Algadeeb R, Faqeehi H, Al-Matary A. Prediction of risk factors and outcomes of neonatal acute kidney injury. J Nephrol. 2021 Oct;34(5):1659-1668. doi: 10.1007/s40620-021-01130-x. Epub 2021 Sep 1.
PubMed 34468977Dobson NR, Patel RM, Smith PB, Kuehn DR, Clark J, Vyas-Read S, Herring A, Laughon MM, Carlton D, Hunt CE. Trends in caffeine use and association between clinical outcomes and timing of therapy in very low birth weight infants. J Pediatr. 2014 May;164(5):992-998.e3. doi: 10.1016/j.jpeds.2013.12.025. Epub 2014 Jan 23.
PubMed 24461786Lee TC, Charles B, Steer P, Flenady V, Shearman A. Population pharmacokinetics of intravenous caffeine in neonates with apnea of prematurity. Clin Pharmacol Ther. 1997 Jun;61(6):628-40. doi: 10.1016/S0009-9236(97)90097-7.
PubMed 9209245Charles BG, Townsend SR, Steer PA, Flenady VJ, Gray PH, Shearman A. Caffeine citrate treatment for extremely premature infants with apnea: population pharmacokinetics, absolute bioavailability, and implications for therapeutic drug monitoring. Ther Drug Monit. 2008 Dec;30(6):709-16. doi: 10.1097/FTD.0b013e3181898b6f.
PubMed 19057373Falcao AC, Fernandez de Gatta MM, Delgado Iribarnegaray MF, Santos Buelga D, Garcia MJ, Dominguez-Gil A, Lanao JM. Population pharmacokinetics of caffeine in premature neonates. Eur J Clin Pharmacol. 1997;52(3):211-7. doi: 10.1007/s002280050276.
PubMed 9218928
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics (PK) and Safety of Caffeine in Neonates With Hypoxic Ischemic Encephalopathy Receiving Therapeutic Hypothermia
- ClinicalTrials.gov ID
- NCT05295784
- Acronym / sponsor ID
- 260845
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Data no longer support this study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 8 May 2024 (actual)
- Primary completion
- 8 May 2024 (actual)
- Study completion
- 8 May 2024 (actual)
- First posted
- 25 Mar 2022 (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.
A phase 1 study investigating the tolerability and pharmacokinetics of caffeine citrate in neonates with hypoxic ischemic encephalopathy receiving therapeutic hypothermia. This study is an essential first step to develop caffeine as a kidney protective medication in this in this vulnerable group of newborns.
Detailed description
Neonatal acute kidney injury (AKI) is an unfortunate comorbidity in neonates with hypoxic ischemic encephalopathy (HIE) which is brain injury due to a lack of blood flow and oxygen delivery to a neonate around the time of delivery. Neonatal AKI increases the risk of death by 4 fold. AKI in neonates with HIE is associated with brain injury on brain MRI and worse neurodevelopmental outcomes at 2 years. Despite the increases in death and morbidity associated with AKI, limited therapeutic interventions currently exist.
Caffeine is a promising medication for kidney protection in neonates at high risk for AKI. Three retrospective studies in premature neonates identified a reduction in AKI in neonates exposed to caffeine. Theophylline, which is in the same drug class as caffeine, has been shown to improve urine output and decrease AKI in neonates with HIE. Limited centers worldwide utilize theophylline in neonates with HIE due to its side effects. Caffeine is a well-tolerated and is extensively utilized in neonatal intensive care units (NICUs) in the premature population for prevention of chronic lung disease and for apnea of prematurity (or immature breathing patterns). Therefore, dosing guidelines are well established for preterm neonates and neonatologists are comfortable administering the drug.
Specific Aim 1: Determine the pharmacokinetics (how an organism affects a drug) of caffeine in neonates ≥ 35 weeks GA with HIE receiving therapeutic hypothermia.
Specific Aim 2: Assess the preliminary safety and tolerability of caffeine in neonates with HIE receiving hypothermia including any impact on seizure burden.
Specific Aim 1: Characterize acute kidney injury (AKI) in neonates with HIE receiving therapeutic hypothermia with caffeine exposure using serum creatinine (SCr), urine output, renal near infrared spectroscopy (NIRS), and urinary biomarkers.
General Experimental Approach:
A total of 18 neonates will be enrolled over approximately 18 months. Each neonate will receive a single dose of caffeine in the first 24 hours of life. The first six neonates will receive low dose (5 mg/kg), the next six neonates will receive a medium dose (15 mg/kg), and the next six neonates will receive high dose or (25 mg/kg).
Demographic data (birthdate, sex, ethnicity, race, gestational age) and clinical data (perinatal birth history, other diagnosis) will be collected from the electronic medical record input into a secure REDCap database created uniquely for this study. Laboratory (serum creatinine) and imaging (head ultrasound and brain MRIs) results will also be recorded.
Blood samples will be obtained from the newborns to monitor the caffeine blood levels. Urine samples will be analyzed for biomarkers that detect kidney damage. Data on seizures and medications will be monitored closely. Blood flow and oxygen levels in the kidney will be monitored with a non-invasive technology called near infrared spectroscopy or NIRS. Data will be collected on urine output and blood creatinine levels to determine which newborns have acute kidney injury.
In conclusion, this study will investigate the drug levels in the blood of caffeine in neonates with HIE receiving therapeutic hypothermia. Safety will also be monitored obtained. The investigators anticipate caffeine is a safe and effective therapy. This study is an essential first step to develop caffeine as a kidney protective medication in this in this vulnerable group of newborns.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Each neonate will receive a single dose of caffeine citrate in the first 24 hours of life. The first six neonates will receive low dose (5 mg/kg), the next six neonates will receive a medium dose (15 mg/kg), and the next six neonates will receive high dose or (25 mg/kg).
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Low dose caffeine | Active comparator | Drug: Caffeine citrateEach neonate will receive a single dose of caffeine citrate in the first 24 hours of life. Arm 1 neonates will receive low dose intravenous caffeine citrate (5 mg/kg). |
| Arm 2: Medium dose caffeine | Active comparator | Drug: Caffeine citrateEach neonate will receive a single dose of caffeine citrate in the first 24 hours of life. Arm 2 neonates will receive medium dose intravenous caffeine citrate (15 mg/kg). |
| Arm 3: High dose caffeine | Active comparator | Drug: Caffeine citrateEach neonate will receive a single dose of caffeine citrate in the first 24 hours of life. Arm 3 neonates will receive high dose intravenous caffeine citrate (25 mg/kg). |
Who may qualify
- Ages
- 0 to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Newborns ≥ 35 weeks GA
- Admitted to the ACH NICU less than 24 hours of life
- Receiving active or passive TH or whole-body cooling at 12 hours of life to treat hypoxic ischemic encephalopathy per institutional criteria based on National Institute of Child Health and Human Development criteria
Key exclusion criteria (7 listed)
- Genetic or congenital condition that affects renal function (e.g., congenital anomalies of the kidney and urinary tract (CAKUT), complex congenital heart disease)
- Diminished capacity or autonomy of the neonate's parents that prevents their ability to give informed consent
- Theophylline, aminophylline, or caffeine exposure prior to enrollment
- Status epilepticus as defined by:
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 |
|---|---|---|
| Caffeine citrateAlso: CafcitA single dose of intravenous caffeine citrate will be administered to neonates with hypoxic ischemic encephalopathy to determine the pharmacokinetics and tolerability. | Drug | Arm 1: Low dose caffeine, Arm 2: Medium dose caffeine, Arm 3: High dose caffeine |
Primary outcome
Clearance of caffeine
Time frame: 1 week
Clearance (mL h-1 kg-1)
Volume of distribution of caffeine
Time frame: 1 week
Volume of distribution (ml/kg)
Peak plasma concentration (Cmax) of caffeine
Time frame: 1 week
Peak plasma concentration (Cmax) (ng/mL)
Area under the plasma concentration-time curve of caffeine
Time frame: 1 week
Area under the plasma concentration-time curve from 0 to infinity (AUC0-INF) (mg*h/L)
Seizure incidence
Time frame: 2 weeks
Number of neonates who developed seizures based on continuous video electroencephalogram (VEEG) data
Seizure burden
Time frame: 2 weeks
Electrographic seizures (in minutes per hour) based on continuous video electroencephalogram (VEEG) data
5 secondary outcomes
Acute kidney injury
Time frame: 10 days
Renal near infrared spectroscopy (NIRS)
Time frame: 5 days
Urine neutrophil gelatinase-associated lipocalin (NGAL) (ng/mL)
Time frame: 3 days
Urine kidney injury molecule-1 (KIM-1) (pg/mL)
Time frame: 3 days
Urine interleukin-18 (IL-18) (pg/mL)
Time frame: 3 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Background: PubMed 34547334Rumpel J, Spray BJ, Chock VY, Kirkley MJ, Slagle CL, Frymoyer A, Cho SH, Gist KM, Blaszak R, Poindexter B, Courtney SE. Urine Biomarkers for the Assessment of Acute Kidney Injury in Neonates with Hypoxic Ischemic Encephalopathy Receiving Therapeutic Hypothermia. J Pediatr. 2022 Feb;241:133-140.e3. doi: 10.1016/j.jpeds.2021.08.090. Epub 2021 Sep 20.
- Background: PubMed 23149172Selewski DT, Jordan BK, Askenazi DJ, Dechert RE, Sarkar S. Acute kidney injury in asphyxiated newborns treated with therapeutic hypothermia. J Pediatr. 2013 Apr;162(4):725-729.e1. doi: 10.1016/j.jpeds.2012.10.002. Epub 2012 Nov 10.
- Background: PubMed 30155763Kirkley MJ, Boohaker L, Griffin R, Soranno DE, Gien J, Askenazi D, Gist KM; Neonatal Kidney Collaborative (NKC). Acute kidney injury in neonatal encephalopathy: an evaluation of the AWAKEN database. Pediatr Nephrol. 2019 Jan;34(1):169-176. doi: 10.1007/s00467-018-4068-2. Epub 2018 Aug 28.
- Background: PubMed 29732396Jetton JG, Boohaker LJ, Sethi SK, Wazir S, Rohatgi S, Soranno DE, Chishti AS, Woroniecki R, Mammen C, Swanson JR, Sridhar S, Wong CS, Kupferman JC, Griffin RL, Askenazi DJ; Neonatal Kidney Collaborative (NKC). Incidence and outcomes of neonatal acute kidney injury (AWAKEN): a multicentre, multinational, observational cohort study. Lancet Child Adolesc Health. 2017 Nov;1(3):184-194. doi: 10.1016/S2352-4642(17)30069-X.
- Background: PubMed 31828471Cavallin F, Rubin G, Vidal E, Cainelli E, Bonadies L, Suppiej A, Trevisanuto D. Prognostic role of acute kidney injury on long-term outcome in infants with hypoxic-ischemic encephalopathy. Pediatr Nephrol. 2020 Mar;35(3):477-483. doi: 10.1007/s00467-019-04406-4. Epub 2019 Dec 11.
- Background: PubMed 30798259Bhatt GC, Gogia P, Bitzan M, Das RR. Theophylline and aminophylline for prevention of acute kidney injury in neonates and children: a systematic review. Arch Dis Child. 2019 Jul;104(7):670-679. doi: 10.1136/archdischild-2018-315805. Epub 2019 Feb 23.
- Background: PubMed 32503030Chock VY, Cho SH, Frymoyer A. Aminophylline for renal protection in neonatal hypoxic-ischemic encephalopathy in the era of therapeutic hypothermia. Pediatr Res. 2021 Mar;89(4):974-980. doi: 10.1038/s41390-020-0999-y. Epub 2020 Jun 5.
- Background: PubMed 29610830Harer MW, Askenazi DJ, Boohaker LJ, Carmody JB, Griffin RL, Guillet R, Selewski DT, Swanson JR, Charlton JR; Neonatal Kidney Collaborative (NKC). Association Between Early Caffeine Citrate Administration and Risk of Acute Kidney Injury in Preterm Neonates: Results From the AWAKEN Study. JAMA Pediatr. 2018 Jun 4;172(6):e180322. doi: 10.1001/jamapediatrics.2018.0322. Epub 2018 Jun 4.
- Background: PubMed 30415418Aviles-Otero N, Kumar R, Khalsa DD, Green G, Carmody JB. Caffeine exposure and acute kidney injury in premature infants with necrotizing enterocolitis and spontaneous intestinal perforation. Pediatr Nephrol. 2019 Apr;34(4):729-736. doi: 10.1007/s00467-018-4140-y. Epub 2018 Nov 10.
- Background: PubMed 26898806Carmody JB, Harer MW, Denotti AR, Swanson JR, Charlton JR. Caffeine Exposure and Risk of Acute Kidney Injury in a Retrospective Cohort of Very Low Birth Weight Neonates. J Pediatr. 2016 May;172:63-68.e1. doi: 10.1016/j.jpeds.2016.01.051. Epub 2016 Feb 18.
- Background: PubMed 34468977AlGadeeb K, Qaraqei M, Algadeeb R, Faqeehi H, Al-Matary A. Prediction of risk factors and outcomes of neonatal acute kidney injury. J Nephrol. 2021 Oct;34(5):1659-1668. doi: 10.1007/s40620-021-01130-x. Epub 2021 Sep 1.
- Background: PubMed 24461786Dobson NR, Patel RM, Smith PB, Kuehn DR, Clark J, Vyas-Read S, Herring A, Laughon MM, Carlton D, Hunt CE. Trends in caffeine use and association between clinical outcomes and timing of therapy in very low birth weight infants. J Pediatr. 2014 May;164(5):992-998.e3. doi: 10.1016/j.jpeds.2013.12.025. Epub 2014 Jan 23.
- 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.
Jennifer Rumpel, MD principal investigator
University of Arkansas
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Caffeine citrate in people with Acute Kidney Injury and Hypoxic-Ischemic Encephalopathy, run by University of Arkansas at 2 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 3 inclusion and 7 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: withdrawn, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clearance of caffeine (time frame: 1 week). The study lists 6 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 NCT05295784, which also lists 33 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 10 May 2024.