Hypoxic Ischaemic Encephalopathy (HIE)
Conditions
Keywords
Hypoxic ischemic encephalopathy (HIE), Melatonin, Randomized Control Trial
Brief 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.
Detailed description
This is a randomized control trial and the purpose of this study is to determine efficacy of melatonin in management of hypoxic ischemic encephalopathy in newborns. Baseline characteristics will be documented after which patients will be divided into two groups by paper lottery method namely group A in which newborns will be given single 10mg dose of melatonin through nasogastric tube in addition to standard supportive therapy and group B in which patients will be given standard supportive therapy only.
Interventions
DRUGMelatonin
55 neonates will be assigned group A in which newborns will be given single 10mg dose of melatonin through nasogastric tube in addition to standard supportive therapy.
COMBINATION_PRODUCTintravenous (IV) fluids, intensive monitoring, broad-spectrum antibiotic cover
55 neonates will be assigned group B in which patients will be given standard supportive therapy only.
Sponsors
University of Child Health Sciences and Children's Hospital, Lahore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
It is a Randomized control trial
Eligibility
Sex/Gender
ALL
Age
1 Hours to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neonate survival rate | 28 days of life | Role of melatonin will be determined primarily by survival rate in neonates with hypoxic ischemic encephalopathy at 28 days of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in stage of HIE | Day 1, 3 and 7 of life | Secondary outcome measures to determine role will be improvement in stage of hypoxic ischemic encephalopathy (based on Thomson score) at day 1, 3 and 7. |
Countries
Pakistan
Outcome results
None listed