Resident Physician - PGY-3 Phoenix Children's Hospital Austin, Texas, United States
Background: Melatonin is a molecule produced in the pineal gland that regulates the circadian rhythm and has been shown to be effective for use in adult and pediatric populations for jet lag, sleep disorders, pain and anxiety. Studies to support use of melatonin as therapy for pain and sedation in neonates are emerging, and its off-label use is becoming more common. Bronchopulmonary dysplasia (BPD) is a form of chronic lung disease associated with preterm birth and involves inflammatory and oxidative injury to lungs at an immature stage of lung development. Here, we seek to explore the effects of melatonin in babies with severe BPD. Objective: The primary aim of this study is to evaluate changes in pain scores in severe BPD patients treated with melatonin. The secondary aim is to investigate changes in opiate use in severe BPD patients treated with melatonin compared to controls. Design/Methods: This is a retrospective case control study conducted with IRB approval at a level IV NICU between 2016 and 2022. Melatonin is prescribed off label to manage pain, agitation, and sleep at a dose of 1mg given enterally. Inclusion criteria involves infants with established grade 3 BPD who either received melatonin (cases) or did not (controls). Exclusion criteria involves babies with congenital brain disorders, genetic disorders, encephalopathy, melatonin therapy that lasted < 7 days or inability to tolerate enteral feeding. We are evaluating NPASS scores (Neonatal Pain, Agitation and Sedation Scale) between 42 and 50 weeks postmenstrual age in cases and controls to evaluate any effect of melatonin on infant pain and sedation. We are also evaluating mean daily opiate use in both groups. Differences in NPASS scores and opiate/benzodiazepine use between groups will be assessed using paired T-test or Wilcoxon signed rank sum test. All tests will be 2-sided with significance evaluated at the 5% level. We plan to have 10 patients in each group and complete data acquisition and analysis by March 31, 2024.
