Active — Not RecruitingPhase 2

EFFICACY OF MELATONIN IN MANAGEMENT OF HYPOXIC ISCHEMIC ENCEPHALOPATHY (HIE) IN NEONATES

Pakistan110 participantsStarted 2025-12-10

Plain-language summary

To compare the survival rate and improvement in stage of hypoxic ischemic encephalopathy (HIE) at day 7 of treatment in neonates treated with versus without melatonin in addition to standard supportive therapy.

Who can participate

Age range1 Hour

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: All term infants (as per operational definition). Both genders. Presenting with hypoxic ischemic encephalopathy (as per operational definition). Exclusion criteria: Drug reactions. Newborns at gestational age \< 36 weeks. Neonates whose mother received general anesthesia. Neonates with congenital malformations. Neonates whose mother received anticonvulsants. Neonates not fulfilling criteria for HIE. Neonatal sepsis, pneumonia or in-born error of metabolism.

What they're measuring

Neonate survival rate

Timeframe: 28 days of life

Trial details

NCT IDNCT07305350

SponsorUniversity of Child Health Sciences and Children's Hospital, Lahore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-10

View on ClinicalTrials.gov More Hypoxic Ischaemic Encephalopathy (HIE) trials