Dexmedetomidine Trial of Adjunct Treatment with Morphine

Approved 06/10/2025, Health and Social Care Research Ethics Committee B (HSC REC B) (Unit 4, Lissue Industrial Estate West, Moira Road, Lisburn, BT28 2RF, United Kingdom; +44 (0)28 9536 1400; recb@hscni.net), ref: 25/NI/0113

Cumulative dose of morphine given over 120 hours from starting the dexmedetomidine or placebo infusion, measured using medication administration records

Measured over 120 hours from the start of infusion:
1. Pain is measured using a standardised preterm pain scale at baseline and every 4 hours over 120 hours from the start of infusion
2. Total duration of morphine infusion is measured in hours using infusion records over 120 hours from the start of infusion
3. Use of additional morphine bolus is measured using medication administration records over 120 hours from the start of infusion
4. Total additional morphine is measured in mg/kg and number of boluses using medication administration records over 120 hours from the start of infusion
5. Morphine and dexmedetomidine exposure is measured using Area Under the Concentration Time Curve (AUC) derived from plasma samples collected over 120 hours from the start of infusion
6. Total dose and duration of other analgesics are measured using medication administration records over 120 hours from the start of infusion
7. Total duration of ventilation is measured in hours using respiratory support records over 120 hours from the start of infusion
8. Number of episodes of bradycardia requiring intervention is measured using clinical observation and intervention records over 120 hours from the start of infusion
9. Heart rate is measured using bedside monitoring data assessed hourly over 120 hours from the start of infusion
10. Blood pressure is measured using bedside monitoring data assessed every two hours over 120 hours from the start of infusion
11. Oxygen saturation is measured using bedside monitoring data assessed hourly over 120 hours from the start of infusion
12. FiO2 is measured using ventilator or oxygen delivery system data assessed hourly over 120 hours from the start of infusion
13. Requirement of additional vasopressor support is measured using medication administration records over 120 hours from the start of infusion

Measured at discharge from neonatal care:
14. Preterm brain injury is measured using cranial ultrasound or MRI at discharge from neonatal care
15. Time to reach at least 140 ml/kg/day full milk feeds is measured in hours using feeding records after randomisation until discharge from neonatal care
16. Bronchopulmonary dysplasia is measured using clinical diagnosis at 36 weeks postmenstrual age or at discharge from neonatal care
17. Length of intensive, high-dependency, and total neonatal care is measured in days using hospital stay records at discharge from neonatal care
18. Parent experience is measured using a self-reported questionnaire at discharge from neonatal care
19. Late-onset infection is measured using microbiological confirmation from clinical samples at any time after 72 hours of life until discharge from neonatal care
20. Necrotising enterocolitis is measured using Bell’s staging criteria (Stage 2 or 3) based on clinical and radiological findings until discharge from neonatal care
21. Retinopathy of prematurity is measured using ophthalmologic examination at standard screening intervals until discharge from neonatal care
22. Death before discharge is measured using clinical records at discharge from neonatal care