HIE - Hypoxic - Ischemic Encephalopathy
Conditions
Brief summary
COMPARISON OF OUTCOME OF HYPOXIC ISCHEMIC ENCEPHALOPATHY MANAGED WITH COMBINATION OF MAGNESIUM SULPHATE AND MELATONIN VERSUS MAGNESIUM SULPHATE ALONE Participants of group A will have 3 doses of MgSO4 infusion at rate of 250mg/kg per day intravenous over 1hour on day 0,1,2 Participants of group B will have 5 doses of Melatonin 10mg/kg for 5days along with MgSO4. They will undergo reassessment of arterial PH and serum LDH after completion of therapy. They will be followed for length of hospital stay and time until feed is initiated.
Interventions
Three doses of MgSO4 infusion at the rate of 250mg/kg per day intravenous over 1 hour on days 0, 1, and 2
DRUGMelatonin , Mgso4
Five doses of melatonin along with three doses of MgSO4 infusion at the rate of 250mg/kg per day intravenous over 1 hour on days 0, 1, and 2
Sponsors
University of Child Health Sciences and Children's Hospital, Lahore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 28 Days
Healthy volunteers
No
Inclusion criteria
* Both genders * Born at term i.e \>37weeks gestation * With APGAR score\<5 at 1min * Umblical artery acidemia(PH\<7 or base deficit\>12mmol/L * Evidence of atleast moderate grade ofHIE on sarnat scoring.
Exclusion criteria
* With congenital anamolies * Intrauterine growth retadation * suspicion of neonatal sepsis * Congenital heart disese and those with IEM.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1.Change in PH 2.Serum LDH(U/L) | 5 DAYS | change in arterial PH,SERUM LDH |
Contacts
CONTACTdr akasha rehman rehman, MD Pedatrics
CONTACTalia ahmed, FCPS,MRCPCH,FRCPCH
Outcome results
None listed