Neonatal Encephalopathy Clinical Trial
— COMETOfficial title:
Optimising the Duration of Cooling Therapy in Mild Neonatal Encephalopathy
Verified date | August 2023 |
Source | Thayyil, Sudhin |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Phase II randomised control trial of whole body cooling in mild neonatal encephalopathy.
Status | Active, not recruiting |
Enrollment | 140 |
Est. completion date | August 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 6 Hours |
Eligibility | INCLUSION CRITERIA All of the following three criteria should be met: 1. Age less than six hours. AND 2. Evidence of acute perinatal asphyxia 1. Metabolic acidosis (pH <7.0 and/or BE >-16) in cord gas or a blood gas within one of birth. OR 2. If the pH or BE is borderline (pH<7.15 to 7.0) and/or BE >-10 to -16) in cord and/or blood gas within 1h of birth additional evidence of perinatal asphyxia is required, which includes either an acute obstetric event (e.g. cord prolapse, abruption, shoulder dystocia) OR Need for continued resuscitation or ventilation at 10 minutes and/or a 10 min Apgar score <6 3. Evidence of mild NE (at-least two abnormalities) on an NICHD neurological examination performed between 1 and 6h of birth. EXCLUSION CRITERIA The following group of babies will be excluded prior to randomisation 1. Babies without encephalopathy 2. Babies with moderate or severe encephalopathy who meet the current NICE/AAP guidelines for cooling therapy. 3. Babies with seizures (clinical and/or aEEG/EEG) 4. Babies with moderate or severe abnormalities on aEEG voltage criteria. 5. Babies with life threatening congenital malformations |
Country | Name | City | State |
---|---|---|---|
Italy | Luigi Vanvitelli Hospital | Naples | |
United Kingdom | Birmingham Womens Hospital | Birmingham | |
United Kingdom | Medway NHS Foundation Trust | Gillingham | |
United Kingdom | Liverpool Womens Hospital | Liverpool | |
United Kingdom | Homerton University Hospital | London | |
United Kingdom | Imperial College London | London | |
United Kingdom | The Newcastle Upon Tyne NHS Foundation Trust | Newcastle | |
United States | Wayne State University | Michigan Center | Michigan |
Lead Sponsor | Collaborator |
---|---|
Thayyil, Sudhin | Wayne State University |
United States, Italy, United Kingdom,
Lally PJ, Montaldo P, Oliveira V, Swamy RS, Soe A, Shankaran S, Thayyil S. Residual brain injury after early discontinuation of cooling therapy in mild neonatal encephalopathy. Arch Dis Child Fetal Neonatal Ed. 2018 Jul;103(4):F383-F387. doi: 10.1136/archdischild-2017-313321. Epub 2017 Sep 21. — View Citation
Lally PJ, Pauliah S, Montaldo P, Chaban B, Oliveira V, Bainbridge A, Soe A, Pattnayak S, Clarke P, Satodia P, Harigopal S, Abernethy LJ, Turner MA, Huertas-Ceballos A, Shankaran S, Thayyil S. Magnetic Resonance Biomarkers in Neonatal Encephalopathy (MARBLE): a prospective multicountry study. BMJ Open. 2015 Sep 30;5(9):e008912. doi: 10.1136/bmjopen-2015-008912. — View Citation
Lally PJ, Price DL, Pauliah SS, Bainbridge A, Kurien J, Sivasamy N, Cowan FM, Balraj G, Ayer M, Satheesan K, Ceebi S, Wade A, Swamy R, Padinjattel S, Hutchon B, Vijayakumar M, Nair M, Padinharath K, Zhang H, Cady EB, Shankaran S, Thayyil S. Neonatal encephalopathic cerebral injury in South India assessed by perinatal magnetic resonance biomarkers and early childhood neurodevelopmental outcome. PLoS One. 2014 Feb 5;9(2):e87874. doi: 10.1371/journal.pone.0087874. eCollection 2014. Erratum In: PLoS One. 2014;9(3):e92526. — View Citation
Oliveira V, Singhvi DP, Montaldo P, Lally PJ, Mendoza J, Manerkar S, Shankaran S, Thayyil S. Therapeutic hypothermia in mild neonatal encephalopathy: a national survey of practice in the UK. Arch Dis Child Fetal Neonatal Ed. 2018 Jul;103(4):F388-F390. doi: 10.1136/archdischild-2017-313320. Epub 2017 Sep 23. — View Citation
Prempunpong C, Chalak LF, Garfinkle J, Shah B, Kalra V, Rollins N, Boyle R, Nguyen KA, Mir I, Pappas A, Montaldo P, Thayyil S, Sanchez PJ, Shankaran S, Laptook AR, Sant'Anna G. Prospective research on infants with mild encephalopathy: the PRIME study. J Perinatol. 2018 Jan;38(1):80-85. doi: 10.1038/jp.2017.164. Epub 2017 Nov 2. — View Citation
Robertson NJ, Thayyil S, Cady EB, Raivich G. Magnetic resonance spectroscopy biomarkers in term perinatal asphyxial encephalopathy: from neuropathological correlates to future clinical applications. Curr Pediatr Rev. 2014;10(1):37-47. doi: 10.2174/157339631001140408120613. — View Citation
Thayyil S, Chandrasekaran M, Taylor A, Bainbridge A, Cady EB, Chong WK, Murad S, Omar RZ, Robertson NJ. Cerebral magnetic resonance biomarkers in neonatal encephalopathy: a meta-analysis. Pediatrics. 2010 Feb;125(2):e382-95. doi: 10.1542/peds.2009-1046. Epub 2010 Jan 18. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Thalamic N-acetyl aspartate level | Feasibility of obtaining Proton MR spectroscopy thalamic N-acetyl aspartate level | 4 to 14 days after birth | |
Secondary | Brain injury on conventional MR imaging | Cortical, white matter or deep nuclei injury | 4 to 14 days after birth | |
Secondary | Hospital stay | Duration of hospital stay | Upto 30 days after birth |
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