Dexmedetomidine Versus Morphine During Cooling Therapy in Neonates
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dexmedetomidine Infusion, Morphine Infusion.
- Who it may be relevant to
- Registry conditions: Hypoxic Ischemic Brain Injury, Neonatal Encephalopathy, Perinatal Anoxic-ischemic Brain Injury. Basic parameters: up to 20 Hours · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparative Efficacy of Dexmedetomidine Versus Morphine in Alleviating Secondary Brain Injury, When Used for Sedation During Hypothermia Therapy in Neonates: A Pilot Randomized Trial
Overview
About \~3/ 1000 live-born newborns may suffer from brain injury due to a transient drop in oxygen supply to the brain during the birth process. The degree of brain injury that ensues in the first 72 hours after the injury is directly proportional to the severity of long-term childhood disabilities (e.g., cerebral palsy and developmental delays). Whole-body cooling during the first 3 days of life is proven effective in reducing the severity of brain injury. However, cooling therapy leads to pain, shivering, stress, and discomfort. The best way to alleviate the pain and agitation of cooled newborns is unknown. Standard practice is to provide morphine infusion to reduce pain. Recently, a new drug called "dexmedetomidine" has been tested in small studies and has been found to be safe during cooling in newborns. Dexmedetomidine has added beneficial effects such as anti-inflammation, faster recovery, and shorter hospital stays. This study is going to test the feasibility of conducting a future clinical trial to compare the effects of using Dexmedetomidine versus morphine in the management of cooling-related pain/agitation on the severity of brain injury in the first week of life. The study will also examine the effect of dexmedetomidine compared to morphine on short-term clinical outcomes, parental experiences and developmental outcomes at 1 year.
Interventions
- Drug 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. - Drug 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.
Primary outcome measures
- Recruitment Rate [Time frame: Day 1]
- Follow Up Rate [Time frame: From enrollment to 1 year of age]
- Adverse Event Rate [Time frame: From enrollment to 7 days of life]
- Discontinuation Rate [Time frame: From enrollment to 7 days of life]
- Protocol Adherence Rate [Time frame: through study completion, average 1 year]
Secondary outcome measures (8)
- Severity of Brain Injury on Magnetic Resonance Imaging (MRI) [Time frame: From enrollment to 10 days of life]
- Seizure Burden during Therapeutic Hypothermia [Time frame: From enrollment to 72 hours of life]
- Stress levels measured by Salivary cortisol assay at 24 and 48 hours [Time frame: From enrollment to 48 hours of life]
- Neonatal Sedation and Discomfort Levels [Time frame: From enrollment to 4 days of life]
- Time to Reach Full Oral Feeds [Time frame: up to 4 weeks of life]
- Cumulative dose of PRN opioid boluses given during therapeutic hypothermia [Time frame: up to 4 days of life]
- Length of Hospital Stay [Time frame: up to 4 weeks of life]
- Days on invasive and non-invasive respiratory support [Time frame: Up to 4 weeks of life]
Eligibility criteria
Inclusion criteria
- Gestational age >= 35 weeks
- Birth weight >= 2500g
- 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
- Sign of Neonatal Encephalopathy
- Initiation of Therapeutic Hypothermia within 8 hours of life
Exclusion criteria
- Informed consent not obtained within 20 hours of life
- Congenital Brain Malformations (antenatally known)
- Major Chromosomal Anomaly (antenatally diagnosed)
- Congenital neuromuscular disorder
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- McMaster Children's Hospital — Hamilton
Publications
- 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. PMID 22182217
- 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. PMID 29246356
- 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. PMID 30721531
- 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. PMID 36746985
- 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. PMID 19692803
- 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. PMID 38115800
- 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. PMID 32158472
- 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. PMID 38060481
Identifiers
NCT: NCT06985290 · 20027280