Dexmedetomidine Versus Morphine During Cooling Therapy in Neonates
NCT ID: NCT06985290
Last Updated: 2025-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE2
50 participants
INTERVENTIONAL
2025-07-01
2028-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Dexmedetomidine Use in Infants Undergoing Cooling Due to Neonatal Encephalopathy (DICE Trial)
NCT04772222
Comparison of Oral 30 % Dextrose and iv Midazolam Sedation During MRI in Neonates
NCT02645279
Umbilical Cord Milking Versus Immediate Cord Clamping in Full Term Neonates (≥ 37 Weeks) Requiring Resuscitation
NCT06090968
The PREMOD Trial: A Randomized Controlled Trial of Umbilical Cord Milking vs. Delayed Cord Clamping in Premature Infants
NCT01866982
Passive Cooling Versus Blanket-Roll III on The Myocardial Function of Asphyxiated Neonates
NCT05652738
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dexmedetomidine Group
Dexmedetomidine infusion as sedation during therapeutic hypothermia and rewarming
Dexmedetomidine Infusion
Dexmedetomidine infusion given for sedation during therapeutic hypothermia. Dexmedetomidine infusion at a starting dose of 0.2 μg/kg/h, with titration in 0.1 μg/kg/h increments with a maximum of 0.5 μg/kg/h based on objective assessment of sedation.
Morphine Group
Morphine infusion as sedative during therapeutic hypothermia and rewarming
Morphine Infusion
Morphine infusion given for sedation during therapeutic hypothermia. Morphine infusion at a starting dose of 4 μg/kg/h, with titration in 2 μg/kg/h increments with a maximum of 10 μg/kg/h based on objective assessment of sedation.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dexmedetomidine Infusion
Dexmedetomidine infusion given for sedation during therapeutic hypothermia. Dexmedetomidine infusion at a starting dose of 0.2 μg/kg/h, with titration in 0.1 μg/kg/h increments with a maximum of 0.5 μg/kg/h based on objective assessment of sedation.
Morphine Infusion
Morphine infusion given for sedation during therapeutic hypothermia. Morphine infusion at a starting dose of 4 μg/kg/h, with titration in 2 μg/kg/h increments with a maximum of 10 μg/kg/h based on objective assessment of sedation.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Birth weight \>= 2500g
3. Sign of perinatal hypoxic event (any of the following): (a) Arterial Cord blood gas or postnatal gas within 1 hour of life pH \<= 7.00 OR Base Deficit \>= 16 (b) Arterial Cord blood gas postnatal gas within 1 hour of life pH 7.00 -7.15 AND Acute sentinel intrapartum event
4. Sign of Neonatal Encephalopathy
5. Initiation of Therapeutic Hypothermia within 8 hours of life
Exclusion Criteria
2. Congenital Brain Malformations (antenatally known)
3. Major Chromosomal Anomaly (antenatally diagnosed)
4. Congenital neuromuscular disorder
20 Hours
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ipsita Goswami
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ipsita Goswami
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ipsita Goswami, MD
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
McMaster Children's Hospital
Hamilton, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Alvik A, Groholt B. Examination of the cut-off scores determined by the Ages and Stages Questionnaire in a population-based sample of 6 month-old Norwegian infants. BMC Pediatr. 2011 Dec 19;11:117. doi: 10.1186/1471-2431-11-117.
Weeke LC, Groenendaal F, Mudigonda K, Blennow M, Lequin MH, Meiners LC, van Haastert IC, Benders MJ, Hallberg B, de Vries LS. A Novel Magnetic Resonance Imaging Score Predicts Neurodevelopmental Outcome After Perinatal Asphyxia and Therapeutic Hypothermia. J Pediatr. 2018 Jan;192:33-40.e2. doi: 10.1016/j.jpeds.2017.09.043.
Craig A, Deerwester K, Fox L, Jacobs J, Evans S. Maternal holding during therapeutic hypothermia for infants with neonatal encephalopathy is feasible. Acta Paediatr. 2019 Sep;108(9):1597-1602. doi: 10.1111/apa.14743. Epub 2019 Mar 5.
Meesters NJ, Dilles T, van Rosmalen J, van den Bosch GE, Simons SHP, van Dijk M. COMFORTneo scale: a reliable and valid instrument to measure prolonged pain in neonates? J Perinatol. 2023 May;43(5):595-600. doi: 10.1038/s41372-023-01628-1. Epub 2023 Feb 6.
van Dijk M, Roofthooft DW, Anand KJ, Guldemond F, de Graaf J, Simons S, de Jager Y, van Goudoever JB, Tibboel D. Taking up the challenge of measuring prolonged pain in (premature) neonates: the COMFORTneo scale seems promising. Clin J Pain. 2009 Sep;25(7):607-16. doi: 10.1097/AJP.0b013e3181a5b52a.
Elliott M, Fairchild K, Zanelli S, McPherson C, Vesoulis Z. Dexmedetomidine During Therapeutic Hypothermia: A Multicenter Quality Initiative. Hosp Pediatr. 2024 Jan 1;14(1):30-36. doi: 10.1542/hpeds.2023-007403.
McAdams RM, Pak D, Lalovic B, Phillips B, Shen DD. Dexmedetomidine Pharmacokinetics in Neonates with Hypoxic-Ischemic Encephalopathy Receiving Hypothermia. Anesthesiol Res Pract. 2020 Feb 25;2020:2582965. doi: 10.1155/2020/2582965. eCollection 2020.
Joshi M, Muneer J, Mbuagbaw L, Goswami I. Analgesia and sedation strategies in neonates undergoing whole-body therapeutic hypothermia: A scoping review. PLoS One. 2023 Dec 7;18(12):e0291170. doi: 10.1371/journal.pone.0291170. eCollection 2023.
Backe P, Bruschettini M, Blomqvist YT, Sibrecht G, Olsson E. Interventions for the Management of Pain and Sedation in Newborns Undergoing Therapeutic Hypothermia for Hypoxic-Ischemic Encephalopathy: A Systematic Review. Paediatr Drugs. 2023 Jan;25(1):27-41. doi: 10.1007/s40272-022-00546-7. Epub 2022 Dec 8.
Walker SM. Long-term effects of neonatal pain. Semin Fetal Neonatal Med. 2019 Aug;24(4):101005. doi: 10.1016/j.siny.2019.04.005. Epub 2019 Apr 5.
Wu Y, Kapse K, Jacobs M, Niforatos-Andescavage N, Donofrio MT, Krishnan A, Vezina G, Wessel D, du Plessis A, Limperopoulos C. Association of Maternal Psychological Distress With In Utero Brain Development in Fetuses With Congenital Heart Disease. JAMA Pediatr. 2020 Mar 1;174(3):e195316. doi: 10.1001/jamapediatrics.2019.5316. Epub 2020 Mar 2.
Thoresen M, Satas S, Loberg EM, Whitelaw A, Acolet D, Lindgren C, Penrice J, Robertson N, Haug E, Steen PA. Twenty-four hours of mild hypothermia in unsedated newborn pigs starting after a severe global hypoxic-ischemic insult is not neuroprotective. Pediatr Res. 2001 Sep;50(3):405-11. doi: 10.1203/00006450-200109000-00017.
van Marken Lichtenbelt WD, Schrauwen P. Implications of nonshivering thermogenesis for energy balance regulation in humans. Am J Physiol Regul Integr Comp Physiol. 2011 Aug;301(2):R285-96. doi: 10.1152/ajpregu.00652.2010. Epub 2011 Apr 13.
Mohammad K, McIntosh S, Lee KS, Beltempo M, Afifi J, Tremblay S, Shah P, Wilson D, Bodani J, Khurshid F, Makary H, Ng E, Wintermark P; NeoBrainNetwork. Variations in care of neonates during therapeutic hypothermia: call for care practice bundle implementation. Pediatr Res. 2023 Jul;94(1):321-330. doi: 10.1038/s41390-022-02453-6. Epub 2023 Jan 9.
Goswami IR, Whyte H, Wintermark P, Mohammad K, Shivananda S, Louis D, Yoon EW, Shah PS; Canadian Neonatal Network Investigators. Characteristics and short-term outcomes of neonates with mild hypoxic-ischemic encephalopathy treated with hypothermia. J Perinatol. 2020 Feb;40(2):275-283. doi: 10.1038/s41372-019-0551-2. Epub 2019 Nov 13.
Jacobs SE, Berg M, Hunt R, Tarnow-Mordi WO, Inder TE, Davis PG. Cooling for newborns with hypoxic ischaemic encephalopathy. Cochrane Database Syst Rev. 2013 Jan 31;2013(1):CD003311. doi: 10.1002/14651858.CD003311.pub3.
Shankaran S. Therapeutic hypothermia for neonatal encephalopathy. Curr Treat Options Neurol. 2012 Dec;14(6):608-19. doi: 10.1007/s11940-012-0200-y.
Kromm GH, Patankar H, Nagalotimath S, Wong H, Austin T. Socioemotional and Psychological Outcomes of Hypoxic-Ischemic Encephalopathy: A Systematic Review. Pediatrics. 2024 Apr 1;153(4):e2023063399. doi: 10.1542/peds.2023-063399.
Pisani F, Orsini M, Braibanti S, Copioli C, Sisti L, Turco EC. Development of epilepsy in newborns with moderate hypoxic-ischemic encephalopathy and neonatal seizures. Brain Dev. 2009 Jan;31(1):64-8. doi: 10.1016/j.braindev.2008.04.001. Epub 2008 May 19.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20027280
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.