The aim of the study
1. To evaluate safety and efficacy of melatonin as an adjuvant therapy to inhaled nitric oxide generated by NO generator in the treatment of pulmonary hypertension in full term neonates. 2. To assess the effect of inhaled nitric oxide and melatonin on cerebral perfusion.
Term neonates with gestational age ≥ 37 weeks.
Mean Pulmonary artery pressure greater than 25mmHg with clinical manifestations as tachypnea, tachycardia, hypoxemia and hypotension
Congenital methemoglobinemia.
Major congenital cardiac anomalies especially duct dependent systemic circulation.
Bleeding tendency.
Patients on other pulmonary vasodilators
Parallel
Melatonin
DrugMelatonin will be given by nasogastric tube at a dose (3 mg/kg) divided every 8 hours till the end of iNO therapy
nitric oxide generator
DeviceiNO will be initiated at 20 ppm. The expected clinical response will be improved oxygenation and cardio-respiratory stability in the first 30 minutes after initiation of iNO therapy.If there is no clinical response, the iNO dose will be increased to up to 40 ppm. If after 30 minutes there is no clinical response, iNO will be discontinued
melatonin as an adjuvant therapy to iNO
1. oxygen saturation % every 3hrs 2. Fraction of inspired oxygen (FiO2) % which will all be measured at baseline (just before iNO administration) and at pre-specified intervals (15, 30, 45, and 60 min) after iNO then every 3hours through the course of study.
effect of iNO and melatonin on cerebral perfusion.
Serum S100B will be measured 24 hours after diagnosis cut off value (≥ 0.10 µg/L) .
Effect of iNO and Melatonin on cerebral perfusion
middle cerebral artery resistive index will be measured before and after starting therapy cutoff value 0.67-0.68
Effect of iNO and Melatonin on electroencephalogram
Burdjalov score before starting treatment during study after completion of therapy. a total ranging from 0 to 13, with higher values indicating a more mature and better organized background.
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