Neonatal EncephalopathyFIREFLYNCT04816331
Follow-up of Inflammatory Responses and Multiorgan Outcomes FoLlowing Neonatal Brain injurY
An observational study of Neonatal Encephalopathy, run by University of Dublin, Trinity College at 5 sites in Ireland.
Trial summary
Babies who have brain injury also frequently have involvement of their kidneys, lung and heart. Although clinical care in the neonatal period is well defined there are few guidelines and evidence for developmental, heart and kidney followup in childhood. Read more about this study
- Who is it for?
- Ages 2 to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Neonatal Encephalopathy
- What is being tested?
- Medical records and clinical measurements
- How many people
- 200 participants
- Where
- 5 sitesIreland
- Study dates
- 4 Aug 2020to 30 Sep 2022
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 2 to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children at 2-3 years of age who were enrolled in the HRB-funded Neonatal Inflammation and Multiorgan dysfunction and Brain injUry reSearch group (NIMBUS) project. These babies had Neonatal Encephalopathy and required Therapeutic Hypothermia and are matched with controls. Patients recruited as part of the NIMBUS study in 3 Dublin Maternity Hospitals: the National Maternity hospital (NMH), the Rotunda hospital \& the Coombe Women's and Infant's University Hospital (CWIUH) with an average of 120 infants with Neonatal encephalopathy (NE) Grade I-III deliveries per annum. This study will enrol 100 infants with NE and 100 controls (recruited in Tallaght University Hospital). The controls include age-matched normal children born at term with a normal delivery and postnatal course.
Who may be able to join
- Children at 2-3 years
- With diagnosis of Neonatal Encephalopathy
- Required Therapeutic Hypothermia
Who cannot join
- -
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Ireland5 sites
The Coombe Women & Infants University Hospital
Dublin
The National Maternity Hospital, or Holles Street Hospital
Dublin
The Rotunda Hospital
Dublin
The Tallaght University Hospital
Dublin
Trinity College Dublin, The University of Dublin
Dublin
About this study
Babies who have brain injury also frequently have involvement of their kidneys, lung and heart. Although clinical care in the neonatal period is well defined there are few guidelines and evidence for developmental, heart and kidney followup in childhood. The investigators aim to develop and implement guidelines for health care workers and families on Followup after Neonatal Brain Injury.
Inflammation is an important factor in brain injury of newborns and also affects their heart lungs and other parts of their body. The investigators will use tests from the newborn period to predict outcome and help parents with planning health needs for their baby rather than waiting until any issues arise later on. By understanding inflammation the investigators can find methods to decrease the negative effects and improve outcomes in the future for babies and families.
Read the detailed description
Neonatal brain injury is an important cause of neonatal death and disability such as cerebral palsy. Perinatal global hypoxic ischemic associated with Neonatal Encephalopathy (NE) results in multi-organ dysfunction which may persist in later childhood. In addition perinatal inflammation has been associated with neonatal brain injury and implicated in adult neuropsychiatric conditions.
The investigators aim to examine multi-organ dysfunction in early childhood in children who had NE by examining detailed cardiac, renal, neurological, haematological and neurodevelopmental outcomes. The investigators have previously defined detailed multi organ dysfunction (MOD) in this cohort in the neonatal period in infants with NE including organ outcomes as well as serum, urine and cerebrospinal fluid (CSF) biomarkers. They are now age-appropriate for detailed neurocognitive assessment and correlation with these biomarkers and the investigators plan to compare with age- matched controls. Immunological markers such as the inflammasome and microRNAs are altered in the neonatal period and may persist in early childhood. The investigators will modify negative inflammatory responses in vitro with specific antagonists as well as correlating these immune biomarkers with outcomes.
Quantifying multiorgan dysfunction in the neonatal period to ensure appropriate follow-up of all organs is merited. This would help in advanced clinical planning and long term follow up. In addition, understanding, the immune response in these children with NE and exploring systemic inflammation holds promise for future development of immunomodulatory adjunctive therapies and biomarkers to predict outcomes.
- Conditions
- Neonatal Encephalopathy
- Being tested
- Medical records and clinical measurements
- Keywords
- Brain Injuries, Multiple Organ Failure, Infant, Inflammation, Neutrophils
- Medical subject headings
- Brain Injuries, Multiple Organ Failure, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical records and clinical measurementsOther
Also called Questionnaires for caregivers to assess social-emotional and adaptive domains, Tissue samples analysis and processing: blood, saliva and urine
Medical records and clinical measurements: Detailed antenatal, birth, resuscitation, oxygen requirements throughout inpatient stay and detailed neonatal intensive care management will be collected. Therapeutic Hypothermia treatment including initiation, duration and clinical examination, and investigations such as scans. In addition, clinical data will include medication, neurological (paediatric developmental psychologist assessment and Bayley Scales of Infant and Toddler Development) and multiorgan examination.
Questionnaires for caregivers to assess social-emotional and adaptive domains.
Tissue samples analysis and processing: Samples of blood, urine and saliva will be used for laboratory testing.
Biomarker correlation with Multiorgan outcomes using statistical analysis: Data collected from medical records, clinical measurements, questionnaires, and tissue processing will be analysed using SPSS software for statistical analysis and modelling.
| Study group | Role | What they receive |
|---|---|---|
| Neonatal Encephalopathy (NE) | This study is a follow up of children at 2-3 years of age who were enrolled in the HRB-funded Neonatal Inflammation and Multiorgan dysfunction and Brain injUry reSearch group (NIMBUS) project. These babies had Neonatal Encephalopathy and required Therapeutic Hypothermia and are matched with controls. Detailed antenatal, birth, resuscitation, oxygen requirements throughout inpatient stay and detailed neonatal intensive care management were collected. In addition, details of Therapeutic Hypothermia treatment including initiation, duration and clinical examination, investigations including cranial USS, MRI, EEG and placental histology analysis performed as were recorded. Receives: Other: Medical records and clinical measurements | |
| Controls | The controls include age-matched normal children born at term with a normal delivery and postnatal course. Receives: Other: Medical records and clinical measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with cardiovascular dysfunction in childhood
It will be determined by normal or abnormal echocardiography using Tissue doppler and functional imaging.
Measured: Children at 2-3 years of age
Number of participants with renal dysfunction in childhood
It will be assessed using renal scoring systems such as the Kidney disease Improving Global Outcomes (KDIGO) Acute Kidney injury score (scores 1 to 3, being 3 worse outcome) and measuring the concentration of urinary biomarkers (in mg/L) such as albumin, B2 microglobulin, Cystatin c, EGF, NGAL, OPN and UMOD. Deviations of the reference range values for the scores and urinary biomarkers will indicate renal dysfunction. Results will be reported as number of patients with renal dysfunction in childhood.
Measured: Children at 2-3 years of age
Number of participants with haematological anomalies persisting in childhood
Number of patients with signs of coagulopathy will be defined using three indicators: APTT/PT (units per seconds), fibrinogen (mg/dL) and Leukocyte/neutrophil (percentage and units per Liter). Deviations of the reference range values for the three indicators will point to haematological anomalies. Results will be reported as number of patients with signs of coagulopathy.
Measured: Children at 2-3 years of age
Number of participants with neurological outcomes
Presence or absence of seizures, motor and sensory dysfunction will be evaluated using Serial Cranial ultrasounds.
Measured: Children at 2-3 years of age
Secondary outcomes (4)
Number and identity of miRNAs upregulated or downregulated in blood of participants.
Between 350 and 800 miRNAs will be assessed in serum from patients and controls.
Measured: Children at 2-3 years of age
Fold change of inflammasome components (NLRP3 and ASC) in RNA isolated from blood of participants.
Using RNA extracted from whole blood of patients and controls, the fold change RNA expression of inflammasome components (NLRP3 and ASC) will be evaluated.
Measured: Children at 2-3 years of age
Concentration level in pg/mL of multicytokines in serum of participants.
Multiplex cytokine analysis will be performed and reported in pg/mL in serum. Cytokines to be included: Interleukin-1 alpha (IL-1α), Interleukin-1 beta (IL- 1β), Interleukin-6 (IL-6), Interleukin-8 (IL-8), Interleukin-10 (IL-10), Tumour Necrosis Factor-alpha (TNF-α), Interferon-gamma (IFN-δ), Vascular Endothelial Growth Factor (VEGF), Granulocyte Colony Stimulating Factor (G-CSF) and Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF), Erythropoietin, Neuronal glial fibrillary acidic protein (GFAP), ubiquitin carboxyl-terminal hydrolase L1 and S100B.
Measured: Children at 2-3 years of age
Bayley Scales of Infant and Toddler development (BSID III) scores of participants.
Bayley Scales of Infant and Toddler development (BSID III) score is an assessment instrument designed to measure motor, cognitive, language, social-emotional, and adaptive behavior development in babies and young children. Composite scores are derived for cognitive, language, and motor development and scaled to a metric, with a mean of 100, standard deviation of 15, and range of 40 to 160. Scores lower than 85 indicating mild impairment, and lower than 70 indicating moderate or severe impairment. Scores equal or higher than 85 indicate normal development.
Measured: Children at 2-3 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start4 Aug 2020
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Neonatal EncephalopathyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Collaborators
- Health Research Board, Ireland
- Responsible party
- Principal investigator, Prof. Eleanor Molloy, University of Dublin, Trinity College
- Investigators
- Eleanor Molloy, Prof., Principal investigator, Professor of Paediatrics & Child Health, Paediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04816331
- Sponsor's protocol ID
- ILP-POR-2019-086
- Acronym
- FIREFLY
- Status last verified
- Mar 2021
- First submitted
- 2 Mar 2021
- Last updated
- 25 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will only be process within the research team associated to the project as per Ethical agreement with the corresponding ethical committees and explicit consent with parents/guardians of the patients.
Publications
Aslam S, Molloy EJ. Biomarkers of multiorgan injury in neonatal encephalopathy. Biomark Med. 2015;9(3):267-75. doi: 10.2217/bmm.14.116.
PubMed 25731212Murray DM, O'Connor CM, Ryan CA, Korotchikova I, Boylan GB. Early EEG Grade and Outcome at 5 Years After Mild Neonatal Hypoxic Ischemic Encephalopathy. Pediatrics. 2016 Oct;138(4):e20160659. doi: 10.1542/peds.2016-0659. Epub 2016 Sep 20.
PubMed 27650049Chalak LF, Nguyen KA, Prempunpong C, Heyne R, Thayyil S, Shankaran S, Laptook AR, Rollins N, Pappas A, Koclas L, Shah B, Montaldo P, Techasaensiri B, Sanchez PJ, Sant'Anna G. Prospective research in infants with mild encephalopathy identified in the first six hours of life: neurodevelopmental outcomes at 18-22 months. Pediatr Res. 2018 Dec;84(6):861-868. doi: 10.1038/s41390-018-0174-x. Epub 2018 Sep 13.
PubMed 30250303Armstrong K, Franklin O, Sweetman D, Molloy EJ. Cardiovascular dysfunction in infants with neonatal encephalopathy. Arch Dis Child. 2012 Apr;97(4):372-5. doi: 10.1136/adc.2011.214205. Epub 2011 Jul 27.
PubMed 21798875Kirkley 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 30155763Morkos AA, Hopper AO, Deming DD, Yellon SM, Wycliffe N, Ashwal S, Sowers LC, Peverini RL, Angeles DM. Elevated total peripheral leukocyte count may identify risk for neurological disability in asphyxiated term neonates. J Perinatol. 2007 Jun;27(6):365-70. doi: 10.1038/sj.jp.7211750. Epub 2007 Apr 19.
PubMed 17443199Buck BH, Liebeskind DS, Saver JL, Bang OY, Yun SW, Starkman S, Ali LK, Kim D, Villablanca JP, Salamon N, Razinia T, Ovbiagele B. Early neutrophilia is associated with volume of ischemic tissue in acute stroke. Stroke. 2008 Feb;39(2):355-60. doi: 10.1161/STROKEAHA.107.490128. Epub 2007 Dec 27.
PubMed 18162626Dammann O, Durum S, Leviton A. Do white cells matter in white matter damage? Trends Neurosci. 2001 Jun;24(6):320-4. doi: 10.1016/s0166-2236(00)01811-7.
PubMed 11356502Jenkins DD, Rollins LG, Perkel JK, Wagner CL, Katikaneni LP, Bass WT, Kaufman DA, Horgan MJ, Languani S, Givelichian L, Sankaran K, Yager JY, Martin RH. Serum cytokines in a clinical trial of hypothermia for neonatal hypoxic-ischemic encephalopathy. J Cereb Blood Flow Metab. 2012 Oct;32(10):1888-96. doi: 10.1038/jcbfm.2012.83. Epub 2012 Jul 18.
PubMed 22805873O'Hare FM, Watson RW, O'Neill A, Segurado R, Sweetman D, Downey P, Mooney E, Murphy J, Donoghue V, Molloy EJ. Serial cytokine alterations and abnormal neuroimaging in newborn infants with encephalopathy. Acta Paediatr. 2017 Apr;106(4):561-567. doi: 10.1111/apa.13745. Epub 2017 Feb 16.
PubMed 28097694O'Hare FM, Watson RW, O'Neill A, Blanco A, Donoghue V, Molloy EJ. Persistent systemic monocyte and neutrophil activation in neonatal encephalopathy. J Matern Fetal Neonatal Med. 2016;29(4):582-9. doi: 10.3109/14767058.2015.1012060. Epub 2015 Feb 19.
PubMed 25694256Lin CY, Chang YC, Wang ST, Lee TY, Lin CF, Huang CC. Altered inflammatory responses in preterm children with cerebral palsy. Ann Neurol. 2010 Aug;68(2):204-12. doi: 10.1002/ana.22049.
PubMed 20695013Hedtjarn M, Mallard C, Iwakura Y, Hagberg H. Combined deficiency of IL-1beta18, but not IL-1alphabeta, reduces susceptibility to hypoxia-ischemia in the immature brain. Dev Neurosci. 2005 Mar-Aug;27(2-4):143-8. doi: 10.1159/000085986.
PubMed 16046848Chevin M, Guiraut C, Sebire G. Effect of hypothermia on interleukin-1 receptor antagonist pharmacodynamics in inflammatory-sensitized hypoxic-ischemic encephalopathy of term newborns. J Neuroinflammation. 2018 Jul 30;15(1):214. doi: 10.1186/s12974-018-1258-6.
PubMed 30060742Ozaki E, Campbell M, Doyle SL. Targeting the NLRP3 inflammasome in chronic inflammatory diseases: current perspectives. J Inflamm Res. 2015 Jan 16;8:15-27. doi: 10.2147/JIR.S51250. eCollection 2015.
PubMed 25653548
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of Inflammatory Responses and Multiorgan Outcomes FoLlowing Neonatal Brain injurY
- ClinicalTrials.gov ID
- NCT04816331
- Acronym / sponsor ID
- FIREFLY / ILP-POR-2019-086
- Conditions
- Neonatal Encephalopathy
- Keywords
- Brain Injuries, Multiple Organ Failure, Infant, Inflammation, Neutrophils
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Collaborators
- Health Research Board, Ireland
- Study start
- 4 Aug 2020 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 25 Mar 2021 (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.
Babies who have brain injury also frequently have involvement of their kidneys, lung and heart. Although clinical care in the neonatal period is well defined there are few guidelines and evidence for developmental, heart and kidney followup in childhood. The investigators aim to develop and implement guidelines for health care workers and families on Followup after Neonatal Brain Injury.
Inflammation is an important factor in brain injury of newborns and also affects their heart lungs and other parts of their body. The investigators will use tests from the newborn period to predict outcome and help parents with planning health needs for their baby rather than waiting until any issues arise later on. By understanding inflammation the investigators can find methods to decrease the negative effects and improve outcomes in the future for babies and families.
Detailed description
Neonatal brain injury is an important cause of neonatal death and disability such as cerebral palsy. Perinatal global hypoxic ischemic associated with Neonatal Encephalopathy (NE) results in multi-organ dysfunction which may persist in later childhood. In addition perinatal inflammation has been associated with neonatal brain injury and implicated in adult neuropsychiatric conditions.
The investigators aim to examine multi-organ dysfunction in early childhood in children who had NE by examining detailed cardiac, renal, neurological, haematological and neurodevelopmental outcomes. The investigators have previously defined detailed multi organ dysfunction (MOD) in this cohort in the neonatal period in infants with NE including organ outcomes as well as serum, urine and cerebrospinal fluid (CSF) biomarkers. They are now age-appropriate for detailed neurocognitive assessment and correlation with these biomarkers and the investigators plan to compare with age- matched controls. Immunological markers such as the inflammasome and microRNAs are altered in the neonatal period and may persist in early childhood. The investigators will modify negative inflammatory responses in vitro with specific antagonists as well as correlating these immune biomarkers with outcomes.
Quantifying multiorgan dysfunction in the neonatal period to ensure appropriate follow-up of all organs is merited. This would help in advanced clinical planning and long term follow up. In addition, understanding, the immune response in these children with NE and exploring systemic inflammation holds promise for future development of immunomodulatory adjunctive therapies and biomarkers to predict outcomes.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neonatal Encephalopathy (NE) | – | Other: Medical records and clinical measurementsThis study is a follow up of children at 2-3 years of age who were enrolled in the HRB-funded Neonatal Inflammation and Multiorgan dysfunction and Brain injUry reSearch group (NIMBUS) project. These babies had Neonatal Encephalopathy and required Therapeutic Hypothermia and are matched with controls. Detailed antenatal, birth, resuscitation, oxygen requirements throughout inpatient stay and detailed neonatal intensive care management were collected. In addition, details of Therapeutic Hypothermia treatment including initiation, duration and clinical examination, investigations including cranial USS, MRI, EEG and placental histology analysis performed as were recorded. |
| Controls | – | Other: Medical records and clinical measurementsThe controls include age-matched normal children born at term with a normal delivery and postnatal course. |
Who may qualify
- Ages
- 2 to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children at 2-3 years of age who were enrolled in the HRB-funded Neonatal Inflammation and Multiorgan dysfunction and Brain injUry reSearch group (NIMBUS) project. These babies had Neonatal Encephalopathy and required Therapeutic Hypothermia and are matched with controls. Patients recruited as part of the NIMBUS study in 3 Dublin Maternity Hospitals: the National Maternity hospital (NMH), the Rotunda hospital \& the Coombe Women's and Infant's University Hospital (CWIUH) with an average of 120 infants with Neonatal encephalopathy (NE) Grade I-III deliveries per annum. This study will enrol 100 infants with NE and 100 controls (recruited in Tallaght University Hospital). The controls include age-matched normal children born at term with a normal delivery and postnatal course.
Key inclusion criteria (3 listed)
- Children at 2-3 years
- With diagnosis of Neonatal Encephalopathy
- Required Therapeutic Hypothermia
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Medical records and clinical measurementsAlso: Questionnaires for caregivers to assess social-emotional and adaptive domains, Tissue samples analysis and processing: blood, saliva and urineMedical records and clinical measurements: Detailed antenatal, birth, resuscitation, oxygen requirements throughout inpatient stay and detailed neonatal intensive care management will be collected. Therapeutic Hypothermia treatment including initiation, duration and clinical examination, and investigations such as scans. In addition, clinical data will include medication, neurological (paediatric developmental psychologist assessment and Bayley Scales of Infant and Toddler Development) and multiorgan examination. Questionnaires for caregivers to assess social-emotional and adaptive domains. Tissue samples analysis and processing: Samples of blood, urine and saliva will be used for laboratory testing. Biomarker correlation with Multiorgan outcomes using statistical analysis: Data collected from medical records, clinical measurements, questionnaires, and tissue processing will be analysed using SPSS software for statistical analysis and modelling. | Other | Controls, Neonatal Encephalopathy (NE) |
Primary outcome
Number of participants with cardiovascular dysfunction in childhood
Time frame: Children at 2-3 years of age
It will be determined by normal or abnormal echocardiography using Tissue doppler and functional imaging.
Number of participants with renal dysfunction in childhood
Time frame: Children at 2-3 years of age
It will be assessed using renal scoring systems such as the Kidney disease Improving Global Outcomes (KDIGO) Acute Kidney injury score (scores 1 to 3, being 3 worse outcome) and measuring the concentration of urinary biomarkers (in mg/L) such as albumin, B2 microglobulin, Cystatin c, EGF, NGAL, OPN and UMOD. Deviations of the reference range values for the scores and urinary biomarkers will indicate renal dysfunction. Results will be reported as number of patients with renal dysfunction in childhood.
Number of participants with haematological anomalies persisting in childhood
Time frame: Children at 2-3 years of age
Number of patients with signs of coagulopathy will be defined using three indicators: APTT/PT (units per seconds), fibrinogen (mg/dL) and Leukocyte/neutrophil (percentage and units per Liter). Deviations of the reference range values for the three indicators will point to haematological anomalies. Results will be reported as number of patients with signs of coagulopathy.
Number of participants with neurological outcomes
Time frame: Children at 2-3 years of age
Presence or absence of seizures, motor and sensory dysfunction will be evaluated using Serial Cranial ultrasounds.
4 secondary outcomes
Number and identity of miRNAs upregulated or downregulated in blood of participants.
Time frame: Children at 2-3 years of age
Fold change of inflammasome components (NLRP3 and ASC) in RNA isolated from blood of participants.
Time frame: Children at 2-3 years of age
Concentration level in pg/mL of multicytokines in serum of participants.
Time frame: Children at 2-3 years of age
Bayley Scales of Infant and Toddler development (BSID III) scores of participants.
Time frame: Children at 2-3 years of age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
- Background: PubMed 25731212Aslam S, Molloy EJ. Biomarkers of multiorgan injury in neonatal encephalopathy. Biomark Med. 2015;9(3):267-75. doi: 10.2217/bmm.14.116.
- Background: PubMed 27650049Murray DM, O'Connor CM, Ryan CA, Korotchikova I, Boylan GB. Early EEG Grade and Outcome at 5 Years After Mild Neonatal Hypoxic Ischemic Encephalopathy. Pediatrics. 2016 Oct;138(4):e20160659. doi: 10.1542/peds.2016-0659. Epub 2016 Sep 20.
- Background: PubMed 30250303Chalak LF, Nguyen KA, Prempunpong C, Heyne R, Thayyil S, Shankaran S, Laptook AR, Rollins N, Pappas A, Koclas L, Shah B, Montaldo P, Techasaensiri B, Sanchez PJ, Sant'Anna G. Prospective research in infants with mild encephalopathy identified in the first six hours of life: neurodevelopmental outcomes at 18-22 months. Pediatr Res. 2018 Dec;84(6):861-868. doi: 10.1038/s41390-018-0174-x. Epub 2018 Sep 13.
- Background: PubMed 21798875Armstrong K, Franklin O, Sweetman D, Molloy EJ. Cardiovascular dysfunction in infants with neonatal encephalopathy. Arch Dis Child. 2012 Apr;97(4):372-5. doi: 10.1136/adc.2011.214205. Epub 2011 Jul 27.
- 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 17443199Morkos AA, Hopper AO, Deming DD, Yellon SM, Wycliffe N, Ashwal S, Sowers LC, Peverini RL, Angeles DM. Elevated total peripheral leukocyte count may identify risk for neurological disability in asphyxiated term neonates. J Perinatol. 2007 Jun;27(6):365-70. doi: 10.1038/sj.jp.7211750. Epub 2007 Apr 19.
- Background: PubMed 18162626Buck BH, Liebeskind DS, Saver JL, Bang OY, Yun SW, Starkman S, Ali LK, Kim D, Villablanca JP, Salamon N, Razinia T, Ovbiagele B. Early neutrophilia is associated with volume of ischemic tissue in acute stroke. Stroke. 2008 Feb;39(2):355-60. doi: 10.1161/STROKEAHA.107.490128. Epub 2007 Dec 27.
- Background: PubMed 11356502Dammann O, Durum S, Leviton A. Do white cells matter in white matter damage? Trends Neurosci. 2001 Jun;24(6):320-4. doi: 10.1016/s0166-2236(00)01811-7.
- Background: PubMed 22805873Jenkins DD, Rollins LG, Perkel JK, Wagner CL, Katikaneni LP, Bass WT, Kaufman DA, Horgan MJ, Languani S, Givelichian L, Sankaran K, Yager JY, Martin RH. Serum cytokines in a clinical trial of hypothermia for neonatal hypoxic-ischemic encephalopathy. J Cereb Blood Flow Metab. 2012 Oct;32(10):1888-96. doi: 10.1038/jcbfm.2012.83. Epub 2012 Jul 18.
- Background: PubMed 28097694O'Hare FM, Watson RW, O'Neill A, Segurado R, Sweetman D, Downey P, Mooney E, Murphy J, Donoghue V, Molloy EJ. Serial cytokine alterations and abnormal neuroimaging in newborn infants with encephalopathy. Acta Paediatr. 2017 Apr;106(4):561-567. doi: 10.1111/apa.13745. Epub 2017 Feb 16.
- Background: PubMed 25694256O'Hare FM, Watson RW, O'Neill A, Blanco A, Donoghue V, Molloy EJ. Persistent systemic monocyte and neutrophil activation in neonatal encephalopathy. J Matern Fetal Neonatal Med. 2016;29(4):582-9. doi: 10.3109/14767058.2015.1012060. Epub 2015 Feb 19.
- Background: PubMed 20695013Lin CY, Chang YC, Wang ST, Lee TY, Lin CF, Huang CC. Altered inflammatory responses in preterm children with cerebral palsy. Ann Neurol. 2010 Aug;68(2):204-12. doi: 10.1002/ana.22049.
- Individual participant dataSharing planned: No. Individual participant data will only be process within the research team associated to the project as per Ethical agreement with the corresponding ethical committees and explicit consent with parents/guardians of the patients.
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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.
Eleanor Molloy, Prof. principal investigator
Professor of Paediatrics & Child Health, Paediatrics
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Encephalopathy, run by University of Dublin, Trinity College at 5 sites in Ireland.
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 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 25 Mar 2021. 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 Ireland. 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?
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?
Number of participants with cardiovascular dysfunction in childhood (time frame: Children at 2-3 years of age). The study lists 4 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 NCT04816331, which also lists 25 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 25 Mar 2021.