COMPARISON OF OUTCOME OF HYPOXIC ISCHEMIC ENCEPHLOPATHY MANAGED WITH COMBINATION OF MAGNESIUM SULPHATE AND MELATONIN VERSUS MAGNESIUM SULPHATE ALONE

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1-28
SponsorUniversity of Child Health Sciences and Children's Hospital, Lahore

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

With congenital anamolies

Intrauterine growth retadation

suspicion of neonatal sepsis

Congenital heart disese and those with IEM.

Trial design

Design model

Parallel

Treatments tested in this trial

  • MgSO4 (seizure prevention)

    Drug

    Three doses of MgSO4 infusion at the rate of 250mg/kg per day intravenous over 1 hour on days 0, 1, and 2

  • Melatonin , Mgso4

    Drug

    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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: melatonin along with Mgso4 infusionExperimental treatment 1 intervention
Group B: Mgso4 aloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

1.Change in PH 2.Serum LDH(U/L)

change in arterial PH,SERUM LDH

Time frame
5 DAYS

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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