Melatonin as a Neuroprotective Therapy in Neonates with HIE undergoing hypothermia

Melatonin is a naturally occurring substance produced mainly from the pineal gland. Melatonin is widely known for its use in regulating the circadian rhythm, but it has many other effects that may benefit infants with HI injury.

This study is non-randomized clinical trial where thirty subjects undergoing hypothermia therapy will be enrolled and will receive different doses of Melatonin.

Infants meeting entry criteria will receive the first dose of melatonin via enteral route within 12 hours of life with a target of 6 hours of life.  Melatonin will be administered after at least 1 hour of hypothermia.

In addition, this study will determine the effect of melatonin on the inflammatory cascade, oxidative stress, free radical production, and serum biomarkers of brain injury in neonates undergoing hypothermia.



  • Hypothermia
  •  Melatonin


  • Phase 1



Age Eligible: Newborn up to 6 hours of life

Sexes Eligible: All


Inclusion Criteria

  • Eligible infants are >36 0/7th weeks gestation
  • pH (cord or neonatal) <7.0
  • Base deficit >16 mEq/L
  • No available blood gas
  • A cord blood/first hour of life blood gas with pH > 7.0 and < 7.15
  • Base deficit between 10 and 15.9 mEq/L
  • Infants must have a history of an acute perinatal event
  • Either a 10-minute Apgar < 5 or a continued need for ventilation
  • All infants must have signs of encephalopathy within 6 hours of age using the modified Sarnat scoring system
  • Neonates cooled within 6 hours of birth

Exclusion Criteria

  • Suspected inborn errors of metabolism (elevated ammonia) and hypoglycemia
  • Clinical signs and symptoms consistent with meningitis detected upon sepsis evaluation
  • A diagnosis of congenital abdominal surgical problems along with multiple congenital anomalies and/or chromosomal abnormalities


External Links