Hypoxic-Ischemic EncephalopathyNCT05986994
Identification of a Pool of miRNA to Improve Early Management of Perinatal Asphyxia and Hypoxic Ischemic Encephalopathy
An observational study of Hypoxic-Ischemic Encephalopathy and Asphyxia Perinatal, run by Ospedale Buon Consiglio Fatebenefratelli at 2 sites in Italy.
Trial summary
Hypoxic-ischemic encephalopathy is the most common cause of neurological damage in the neonatal period. It has an incidence of about 1.5-2.5% of livebirths in developed countries. It is associated with a high rate of mortality and morbidity. Read more about this study
- Who is it for?
- Ages 35 to 42 weeks
- Conditions the study is for
- Hypoxic-Ischemic Encephalopathy, Asphyxia Perinatal
- What is being tested?
- Metabolic acidosis, microRNA and Hypothermia
- How many people
- 45 participants
- Where
- 2 sitesItaly
- Study dates
- 18 Jul 2023to 1 Sep 2024
- 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 35 to 42 weeks
- All sexes
- Child
Study population: All patients transferred to the Buon Consiglio Fatebenefratelli hospital will be eligible
Who may be able to join
- newborns with at least 35 weeks of gestational age
- body weight of at least 1800 g
Who cannot join
- Withdrawal of informed consent
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Department of Woman and Child, Buon Consiglio Fatebenefratelli Hospital
Naples, 80123
Department of Neuroscience, Reproductive and Dentistry Sciences, University of Naples Federico II
Naples, 80131
About this study
Official title: Role of microRNAs as Diagnostic and Prognostic Biomarkers of Neonatal Perinatal Asphyxia and Hypoxic Ischemic Encephalopathy
Hypoxic-ischemic encephalopathy is the most common cause of neurological damage in the neonatal period. It has an incidence of about 1.5-2.5% of livebirths in developed countries. It is associated with a high rate of mortality and morbidity. Major neurological outcomes such as cerebral palsy, mental retardation, learning disabilities, epilepsy occur in approximately 25% of survivors. The diagnostic and prognostic tools currently available for enrollment have limitations and additional reliable biomarkers are needed for all phases of clinical management. Sarnat staging has taken on a role in identifying those infants who may benefit from treatment of hypothermia, resulting in the need for neurological evaluation and staging within 6 hours of life. Therapeutic hypothermia is still the best therapeutic treatment.
A new tool in neuroscience research is represented by micro-ribonucleic acid (microRNA) profiling. The presence of microRNAs in blood, urine and saliva and the ability to measure their levels non-invasively has opened new doors in the search for peripheral biomarkers for the diagnosis and prognosis of neurodegenerative diseases and also as possible pharmacological targets.
The aim of the present study is to analyze a specific cluster of miRNAs selected from data obtained by macroarray (NGS Pannel) on the entire microRNAome in healthy newborns with normal cord arterial pH value (7.26-7.35) as control cases and in newborns with fetal metabolic acidosis with a pH threshold value lower than 7.12 of the blood gas analysis from cord arterial blood. This latter group will be further stratified into two groups, neonates who will practice therapeutic hypothermia according to current guidelines and a further group who will not practice therapeutic hypothermia. This study will make a further international contribution in evaluating and identifying the potential of microRNAs as diagnostic and prognostic biomarkers in perinatal asphyxia and hypoxic ischemic encephalopathy. Furthermore, the study aims to identify specific microRNA sequences as new possible markers to be used as an additional parameter for the enrollment of therapeutic hypothermia, especially in cases of mild hypoxic-ischemic encephalopathy.
Read the detailed description
Hypoxic-ischemic encephalopathy is the most common cause of neurological damage in the neonatal period. It has an incidence of about 1.5-2.5% of livebirths in developed countries. It is associated with a high rate of mortality and morbidity. About 1 million newborns worldwide die of hypoxic-ischemic encephalopathy. In the neonatal period die between 20 and 50% of asphyxiated infants who develop hypoxic-ischemic encephalopathy. Major neurological outcomes such as cerebral palsy, mental retardation, learning disabilities, epilepsy occur in approximately 25% of survivors. Therapeutic hypothermia is still the best therapeutic treatment. The diagnostic and prognostic tools currently available for enrollment have limitations and additional reliable biomarkers are needed for all phases of clinical management. One of the difficulties in interpretation lies in the identification of mild-grade hypoxic-ischemic encephalopathy which appears to be operator dependent, as well as the timing of the diagnosis. Sarnat staging has taken on a role in identifying those infants who may benefit from treatment of hypothermia, resulting in the need for neurological evaluation and staging within 6 hours of life. This is a relatively short time frame in which it is plausible to think that mild hypoxic-ischemic encephalopathy could become moderate at 6 h. In fact, some studies have retrospectively demonstrated the outcome of infants with mild hypoxic-ischemic encephalopathy defined between 1 and 6 hours of birth showing worse neurodevelopmental outcomes than the data reported in the pre-hypothermia literature.
A new tool in neuroscience research is represented micro-ribonucleic acid (microRNA) profiling. Significant numbers of microRNAs have been observed outside cells including various body fluids. MicroRNAs have been detected in plasma, serum, milk, tears, saliva, urine, amniotic fluid, cerebrospinal fluid, and seminal fluid. Despite the instability of most RNA molecules in the extracellular environment, the presence and apparent stability of microRNAs has proven surprising. In particular, they were found to be very stable and resistant to RNases, freezing and pH variations. The presence of microRNAs in blood, urine and saliva and the ability to measure their levels non-invasively has opened new doors in the search for peripheral biomarkers for the diagnosis and prognosis of neurodegenerative diseases and also as possible pharmacological targets. In view of their usefulness, in recent years more and more different microRNAs have been analyzed as possible diagnostic and prognostic markers of perinatal asphyxia but specific sequences with high specificity and sensitivity have not yet been identified as markers of neonatal hypoxia and hypoxic ischemic encephalopathy with the need to perform further confirmatory studies. The aim of the present study is to analyze a specific cluster of miRNAs selected from data obtained by macroarray (NGS Pannel) on the entire microRNAome in healthy newborns with normal cord arterial pH value (7.26-7.35) as control cases and in newborns with fetal metabolic acidosis with a pH threshold value lower than 7.12 of the blood gas analysis from cord arterial blood. This latter group will be further stratified into two groups, neonates who will practice therapeutic hypothermia according to current guidelines and a further group who will not practice therapeutic hypothermia. This study will make a further international contribution in evaluating and identifying the potential of microRNAs as diagnostic and prognostic biomarkers in perinatal asphyxia and hypoxic ischemic encephalopathy. Furthermore, the study aims to identify specific microRNA sequences as new possible markers to be used as an additional parameter for the enrollment of therapeutic hypothermia, especially in cases of mild hypoxic-ischemic encephalopathy. Subsequently, this study will allow to evaluate their potential as new possible pharmacological targets in the pediatric field for hypoxic-ischemic encephalopathy in future preclinical studies as already reported in the literature in various preclinical studies, as therapeutic perspectives in ischemic stroke in adults.
- Being tested
- Metabolic acidosis, microRNA, Hypothermia
- Keywords
- newborn, microRNA, asphyxia, encephalopathy, hypothermia
- Medical subject headings
- Hypoxia-Ischemia, Brain, Asphyxia, Brain Diseases, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metabolic acidosisOther
Metabolic acidosis at birth with umbilical cord arterial pH at birth < 7.12
microRNADiagnostic test
Evaluation of microRNA levels
HypothermiaOther
Therapeutic induced hypothermia refers to a lowering of the central body temperature for therapeutic purposes
| Study group | Role | What they receive |
|---|---|---|
| Group A | 15 healthy newborns with umbilical cord arterial pH between 7.26 and 7.35 Receives: Diagnostic Test: microRNA | |
| Group B | 15 newborns with metabolic acidosis at birth with umbilical cord arterial pH at birth < 7.12 and who do not practice therapeutic hypothermia due to lack of enrollment criteria Receives: Other: Metabolic acidosis; Diagnostic Test: microRNA | |
| Group C | 15 newborns with metabolic acidosis at birth with umbilical cord arterial pH at birth < 7.12 and practicing therapeutic hypothermia in accordance with current guidelines Receives: Other: Metabolic acidosis; Diagnostic Test: microRNA; Other: Hypothermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of microRNA levels
Quantitative characterization of microRNAs (ng/uL) in healthy neonates and neonates with metabolic acidosis at birth with or without therapeutic hypothermia and who developed hypoxic ischemic encephalopathy
Measured: 60 minutes of life
Qualitative evaluation of microRNAs
Characterization of the type of microRNAs in healthy neonates and neonates with metabolic acidosis at birth with or without therapeutic hypothermia and who developed hypoxic ischemic encephalopathy
Measured: 60 minutes of life
Evaluation of microRNA levels
Quantitative characterization of microRNAs (ng/uL) in healthy neonates and neonates with metabolic acidosis at birth with or without therapeutic hypothermia and who developed hypoxic ischemic encephalopathy
Measured: 3 hours of life
Qualitative evaluation of microRNAs
Characterization of the type of microRNAs in healthy neonates and neonates with metabolic acidosis at birth with or without therapeutic hypothermia and who developed hypoxic ischemic encephalopathy
Measured: 3 hours of life
Evaluation of microRNA levels
Quantitative characterization of microRNAs (ng/uL) in healthy neonates and neonates with metabolic acidosis at birth with or without therapeutic hypothermia and who developed hypoxic ischemic encephalopathy
Measured: 72 hours of life
Qualitative evaluation of microRNAs
Characterization of the type of microRNAs in healthy neonates and neonates with metabolic acidosis at birth with or without therapeutic hypothermia and who developed hypoxic ischemic encephalopathy
Measured: 72 hours of life
Secondary outcomes (6)
Predictive role of microRNAs
To assess the role of microRNAs as marker of perinatal asphyxia
Measured: 60 minutes of life
Predictive role of microRNAs
To assess the role of microRNAs as markers of mild hypoxic ischemic encephalopathy
Measured: 60 minutes of life
Predictive role of microRNAs
To assess the role of microRNAs as markers of perinatal asphyxia
Measured: 3 hours of life
Predictive role of microRNAs
To assess the role of microRNAs as markers of mild hypoxic ischemic encephalopathy
Measured: 3 hours of life
Predictive role of microRNAs
To assess the role of microRNAs as markers of perinatal asphyxia
Measured: 72 hours of life
Predictive role of microRNAs
To assess the role of microRNAs as markers of mild hypoxic ischemic encephalopathy
Measured: 72 hours of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start18 Jul 2023
- Primary completion18 Jul 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Hypoxic-Ischemic 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Buon Consiglio Fatebenefratelli
- Sponsor type
- University, hospital or other
- Collaborators
- Federico II University
- Responsible party
- Principal investigator, Giuseppe De Bernardo, Ospedale Buon Consiglio Fatebenefratelli
- Investigators
- Giuseppe De Bernardo, Prof, Principal investigator, Buon Consiglio Fatebenefratelli Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05986994
- Sponsor's protocol ID
- 495
- Status last verified
- Jun 2026
- First submitted
- 8 Jul 2023
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gunn AJ. Cerebral hypothermia for prevention of brain injury following perinatal asphyxia. Curr Opin Pediatr. 2000 Apr;12(2):111-5. doi: 10.1097/00008480-200004000-00004.
PubMed 10763759Vinciguerra A, Cepparulo P, Anzilotti S, Cuomo O, Valsecchi V, Amoroso S, Annunziato L, Pignataro G. Remote postconditioning ameliorates stroke damage by preventing let-7a and miR-143 up-regulation. Theranostics. 2020 Oct 27;10(26):12174-12188. doi: 10.7150/thno.48135. eCollection 2020.
PubMed 33204336DE Bernardo G, Riccitelli M, Giordano M, Toni AL, Sordino D, Trevisanuto D, Buonocore G, Perrone S. Does high fidelity neonatal resuscitation simulation increase salivary cortisol levels of health care providers? Minerva Pediatr (Torino). 2023 Dec;75(6):884-889. doi: 10.23736/S2724-5276.21.05873-0. Epub 2021 Jun 21.
PubMed 34152109Locci E, Bazzano G, Demontis R, Chighine A, Fanos V, d'Aloja E. Exploring Perinatal Asphyxia by Metabolomics. Metabolites. 2020 Apr 4;10(4):141. doi: 10.3390/metabo10040141.
PubMed 32260446Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
PubMed 17695343De Bernardo G, De Santis R, Giordano M, Sordino D, Buonocore G, Perrone S. Predict respiratory distress syndrome by umbilical cord blood gas analysis in newborns with reassuring Apgar score. Ital J Pediatr. 2020 Feb 12;46(1):20. doi: 10.1186/s13052-020-0786-8.
PubMed 32050997Hull J, Dodd KL. Falling incidence of hypoxic-ischaemic encephalopathy in term infants. Br J Obstet Gynaecol. 1992 May;99(5):386-91. doi: 10.1111/j.1471-0528.1992.tb13754.x.
PubMed 1622910Conway JM, Walsh BH, Boylan GB, Murray DM. Mild hypoxic ischaemic encephalopathy and long term neurodevelopmental outcome - A systematic review. Early Hum Dev. 2018 May;120:80-87. doi: 10.1016/j.earlhumdev.2018.02.007. Epub 2018 Feb 26.
PubMed 29496329O'Sullivan MP, Looney AM, Moloney GM, Finder M, Hallberg B, Clarke G, Boylan GB, Murray DM. Validation of Altered Umbilical Cord Blood MicroRNA Expression in Neonatal Hypoxic-Ischemic Encephalopathy. JAMA Neurol. 2019 Mar 1;76(3):333-341. doi: 10.1001/jamaneurol.2018.4182.
PubMed 30592487Ponnusamy V, Yip PK. The role of microRNAs in newborn brain development and hypoxic ischaemic encephalopathy. Neuropharmacology. 2019 May 1;149:55-65. doi: 10.1016/j.neuropharm.2018.11.041. Epub 2019 Feb 1.
PubMed 30716413Walsh BH, Inder TE. MRI as a biomarker for mild neonatal encephalopathy. Early Hum Dev. 2018 May;120:75-79. doi: 10.1016/j.earlhumdev.2018.02.006. Epub 2018 Feb 17.
PubMed 29463417Weber JA, Baxter DH, Zhang S, Huang DY, Huang KH, Lee MJ, Galas DJ, Wang K. The microRNA spectrum in 12 body fluids. Clin Chem. 2010 Nov;56(11):1733-41. doi: 10.1373/clinchem.2010.147405. Epub 2010 Sep 16.
PubMed 20847327
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of microRNAs as Diagnostic and Prognostic Biomarkers of Neonatal Perinatal Asphyxia and Hypoxic Ischemic Encephalopathy
- ClinicalTrials.gov ID
- NCT05986994
- Acronym / sponsor ID
- 495
- Keywords
- newborn, microRNA, asphyxia, encephalopathy, hypothermia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Ospedale Buon Consiglio FatebenefratelliUniversity, hospital or other
- Collaborators
- Federico II University
- Study start
- 18 Jul 2023 (actual)
- Primary completion
- 18 Jul 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 14 Aug 2023 (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.
Hypoxic-ischemic encephalopathy is the most common cause of neurological damage in the neonatal period. It has an incidence of about 1.5-2.5% of livebirths in developed countries. It is associated with a high rate of mortality and morbidity. Major neurological outcomes such as cerebral palsy, mental retardation, learning disabilities, epilepsy occur in approximately 25% of survivors. The diagnostic and prognostic tools currently available for enrollment have limitations and additional reliable biomarkers are needed for all phases of clinical management. Sarnat staging has taken on a role in identifying those infants who may benefit from treatment of hypothermia, resulting in the need for neurological evaluation and staging within 6 hours of life. Therapeutic hypothermia is still the best therapeutic treatment.
A new tool in neuroscience research is represented by micro-ribonucleic acid (microRNA) profiling. The presence of microRNAs in blood, urine and saliva and the ability to measure their levels non-invasively has opened new doors in the search for peripheral biomarkers for the diagnosis and prognosis of neurodegenerative diseases and also as possible pharmacological targets.
The aim of the present study is to analyze a specific cluster of miRNAs selected from data obtained by macroarray (NGS Pannel) on the entire microRNAome in healthy newborns with normal cord arterial pH value (7.26-7.35) as control cases and in newborns with fetal metabolic acidosis with a pH threshold value lower than 7.12 of the blood gas analysis from cord arterial blood. This latter group will be further stratified into two groups, neonates who will practice therapeutic hypothermia according to current guidelines and a further group who will not practice therapeutic hypothermia. This study will make a further international contribution in evaluating and identifying the potential of microRNAs as diagnostic and prognostic biomarkers in perinatal asphyxia and hypoxic ischemic encephalopathy. Furthermore, the study aims to identify specific microRNA sequences as new possible markers to be used as an additional parameter for the enrollment of therapeutic hypothermia, especially in cases of mild hypoxic-ischemic encephalopathy.
Detailed description
Hypoxic-ischemic encephalopathy is the most common cause of neurological damage in the neonatal period. It has an incidence of about 1.5-2.5% of livebirths in developed countries. It is associated with a high rate of mortality and morbidity. About 1 million newborns worldwide die of hypoxic-ischemic encephalopathy. In the neonatal period die between 20 and 50% of asphyxiated infants who develop hypoxic-ischemic encephalopathy. Major neurological outcomes such as cerebral palsy, mental retardation, learning disabilities, epilepsy occur in approximately 25% of survivors. Therapeutic hypothermia is still the best therapeutic treatment. The diagnostic and prognostic tools currently available for enrollment have limitations and additional reliable biomarkers are needed for all phases of clinical management. One of the difficulties in interpretation lies in the identification of mild-grade hypoxic-ischemic encephalopathy which appears to be operator dependent, as well as the timing of the diagnosis. Sarnat staging has taken on a role in identifying those infants who may benefit from treatment of hypothermia, resulting in the need for neurological evaluation and staging within 6 hours of life. This is a relatively short time frame in which it is plausible to think that mild hypoxic-ischemic encephalopathy could become moderate at 6 h. In fact, some studies have retrospectively demonstrated the outcome of infants with mild hypoxic-ischemic encephalopathy defined between 1 and 6 hours of birth showing worse neurodevelopmental outcomes than the data reported in the pre-hypothermia literature.
A new tool in neuroscience research is represented micro-ribonucleic acid (microRNA) profiling. Significant numbers of microRNAs have been observed outside cells including various body fluids. MicroRNAs have been detected in plasma, serum, milk, tears, saliva, urine, amniotic fluid, cerebrospinal fluid, and seminal fluid. Despite the instability of most RNA molecules in the extracellular environment, the presence and apparent stability of microRNAs has proven surprising. In particular, they were found to be very stable and resistant to RNases, freezing and pH variations. The presence of microRNAs in blood, urine and saliva and the ability to measure their levels non-invasively has opened new doors in the search for peripheral biomarkers for the diagnosis and prognosis of neurodegenerative diseases and also as possible pharmacological targets. In view of their usefulness, in recent years more and more different microRNAs have been analyzed as possible diagnostic and prognostic markers of perinatal asphyxia but specific sequences with high specificity and sensitivity have not yet been identified as markers of neonatal hypoxia and hypoxic ischemic encephalopathy with the need to perform further confirmatory studies. The aim of the present study is to analyze a specific cluster of miRNAs selected from data obtained by macroarray (NGS Pannel) on the entire microRNAome in healthy newborns with normal cord arterial pH value (7.26-7.35) as control cases and in newborns with fetal metabolic acidosis with a pH threshold value lower than 7.12 of the blood gas analysis from cord arterial blood. This latter group will be further stratified into two groups, neonates who will practice therapeutic hypothermia according to current guidelines and a further group who will not practice therapeutic hypothermia. This study will make a further international contribution in evaluating and identifying the potential of microRNAs as diagnostic and prognostic biomarkers in perinatal asphyxia and hypoxic ischemic encephalopathy. Furthermore, the study aims to identify specific microRNA sequences as new possible markers to be used as an additional parameter for the enrollment of therapeutic hypothermia, especially in cases of mild hypoxic-ischemic encephalopathy. Subsequently, this study will allow to evaluate their potential as new possible pharmacological targets in the pediatric field for hypoxic-ischemic encephalopathy in future preclinical studies as already reported in the literature in various preclinical studies, as therapeutic perspectives in ischemic stroke in adults.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Diagnostic Test: microRNA15 healthy newborns with umbilical cord arterial pH between 7.26 and 7.35 |
| Group B | – | Other: Metabolic acidosis, Diagnostic Test: microRNA15 newborns with metabolic acidosis at birth with umbilical cord arterial pH at birth < 7.12 and who do not practice therapeutic hypothermia due to lack of enrollment criteria |
| Group C | – | Other: Metabolic acidosis, Diagnostic Test: microRNA, Other: Hypothermia15 newborns with metabolic acidosis at birth with umbilical cord arterial pH at birth < 7.12 and practicing therapeutic hypothermia in accordance with current guidelines |
Who may qualify
- Ages
- 35 to 42 weeks
- Sex
- All
- Age groups
- Child
- Study population
- All patients transferred to the Buon Consiglio Fatebenefratelli hospital will be eligible
Key inclusion criteria (2 listed)
- newborns with at least 35 weeks of gestational age
- body weight of at least 1800 g
Key exclusion criteria (1 listed)
- Withdrawal of informed consent
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 |
|---|---|---|
| Metabolic acidosisMetabolic acidosis at birth with umbilical cord arterial pH at birth < 7.12 | Other | Group B, Group C |
| microRNAEvaluation of microRNA levels | Diagnostic test | Group A, Group B, Group C |
| HypothermiaTherapeutic induced hypothermia refers to a lowering of the central body temperature for therapeutic purposes | Other | Group C |
Primary outcome
Evaluation of microRNA levels
Time frame: 60 minutes of life
Quantitative characterization of microRNAs (ng/uL) in healthy neonates and neonates with metabolic acidosis at birth with or without therapeutic hypothermia and who developed hypoxic ischemic encephalopathy
Qualitative evaluation of microRNAs
Time frame: 60 minutes of life
Characterization of the type of microRNAs in healthy neonates and neonates with metabolic acidosis at birth with or without therapeutic hypothermia and who developed hypoxic ischemic encephalopathy
Evaluation of microRNA levels
Time frame: 3 hours of life
Quantitative characterization of microRNAs (ng/uL) in healthy neonates and neonates with metabolic acidosis at birth with or without therapeutic hypothermia and who developed hypoxic ischemic encephalopathy
Qualitative evaluation of microRNAs
Time frame: 3 hours of life
Characterization of the type of microRNAs in healthy neonates and neonates with metabolic acidosis at birth with or without therapeutic hypothermia and who developed hypoxic ischemic encephalopathy
Evaluation of microRNA levels
Time frame: 72 hours of life
Quantitative characterization of microRNAs (ng/uL) in healthy neonates and neonates with metabolic acidosis at birth with or without therapeutic hypothermia and who developed hypoxic ischemic encephalopathy
Qualitative evaluation of microRNAs
Time frame: 72 hours of life
Characterization of the type of microRNAs in healthy neonates and neonates with metabolic acidosis at birth with or without therapeutic hypothermia and who developed hypoxic ischemic encephalopathy
6 secondary outcomes
Predictive role of microRNAs
Time frame: 60 minutes of life
Predictive role of microRNAs
Time frame: 60 minutes of life
Predictive role of microRNAs
Time frame: 3 hours of life
Predictive role of microRNAs
Time frame: 3 hours of life
Predictive role of microRNAs
Time frame: 72 hours of life
Predictive role of microRNAs
Time frame: 72 hours of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Results publication: PubMed 10763759Gunn AJ. Cerebral hypothermia for prevention of brain injury following perinatal asphyxia. Curr Opin Pediatr. 2000 Apr;12(2):111-5. doi: 10.1097/00008480-200004000-00004.
- Results publication: PubMed 33204336Vinciguerra A, Cepparulo P, Anzilotti S, Cuomo O, Valsecchi V, Amoroso S, Annunziato L, Pignataro G. Remote postconditioning ameliorates stroke damage by preventing let-7a and miR-143 up-regulation. Theranostics. 2020 Oct 27;10(26):12174-12188. doi: 10.7150/thno.48135. eCollection 2020.
- Results publication: PubMed 34152109DE Bernardo G, Riccitelli M, Giordano M, Toni AL, Sordino D, Trevisanuto D, Buonocore G, Perrone S. Does high fidelity neonatal resuscitation simulation increase salivary cortisol levels of health care providers? Minerva Pediatr (Torino). 2023 Dec;75(6):884-889. doi: 10.23736/S2724-5276.21.05873-0. Epub 2021 Jun 21.
- Results publication: PubMed 32260446Locci E, Bazzano G, Demontis R, Chighine A, Fanos V, d'Aloja E. Exploring Perinatal Asphyxia by Metabolomics. Metabolites. 2020 Apr 4;10(4):141. doi: 10.3390/metabo10040141.
- Results publication: PubMed 17695343Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
- Results publication: PubMed 32050997De Bernardo G, De Santis R, Giordano M, Sordino D, Buonocore G, Perrone S. Predict respiratory distress syndrome by umbilical cord blood gas analysis in newborns with reassuring Apgar score. Ital J Pediatr. 2020 Feb 12;46(1):20. doi: 10.1186/s13052-020-0786-8.
- Results publication: PubMed 1622910Hull J, Dodd KL. Falling incidence of hypoxic-ischaemic encephalopathy in term infants. Br J Obstet Gynaecol. 1992 May;99(5):386-91. doi: 10.1111/j.1471-0528.1992.tb13754.x.
- Results publication: PubMed 29496329Conway JM, Walsh BH, Boylan GB, Murray DM. Mild hypoxic ischaemic encephalopathy and long term neurodevelopmental outcome - A systematic review. Early Hum Dev. 2018 May;120:80-87. doi: 10.1016/j.earlhumdev.2018.02.007. Epub 2018 Feb 26.
- Results publication: PubMed 30592487O'Sullivan MP, Looney AM, Moloney GM, Finder M, Hallberg B, Clarke G, Boylan GB, Murray DM. Validation of Altered Umbilical Cord Blood MicroRNA Expression in Neonatal Hypoxic-Ischemic Encephalopathy. JAMA Neurol. 2019 Mar 1;76(3):333-341. doi: 10.1001/jamaneurol.2018.4182.
- Results publication: PubMed 30716413Ponnusamy V, Yip PK. The role of microRNAs in newborn brain development and hypoxic ischaemic encephalopathy. Neuropharmacology. 2019 May 1;149:55-65. doi: 10.1016/j.neuropharm.2018.11.041. Epub 2019 Feb 1.
- Results publication: PubMed 29463417Walsh BH, Inder TE. MRI as a biomarker for mild neonatal encephalopathy. Early Hum Dev. 2018 May;120:75-79. doi: 10.1016/j.earlhumdev.2018.02.006. Epub 2018 Feb 17.
- Results publication: PubMed 20847327Weber JA, Baxter DH, Zhang S, Huang DY, Huang KH, Lee MJ, Galas DJ, Wang K. The microRNA spectrum in 12 body fluids. Clin Chem. 2010 Nov;56(11):1733-41. doi: 10.1373/clinchem.2010.147405. Epub 2010 Sep 16.
- 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.
Giuseppe De Bernardo, Prof principal investigator
Buon Consiglio Fatebenefratelli Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxic-Ischemic Encephalopathy and Asphyxia Perinatal, run by Ospedale Buon Consiglio Fatebenefratelli at 2 sites in Italy.
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 2 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: finished, as of the sponsor's last update on 5 Jun 2026. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of microRNA levels (time frame: 60 minutes of life). 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 NCT05986994, which also lists 12 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 5 Jun 2026.