Health Condition 1: P293- Persistent fetal circulation
Conditions
Interventions
Intervention1: Inhaled Milrinone, Oral Sildenafil: Inhaled milrinone (inj milrinone 1mg/ml, dissolved in 10 ml NS)
The dose of inhaled milrinone will be 50 microgram/kg bodyweight over 10
minutes
Fre
Sponsors
Dr Rameshwar Prasad
Eligibility
Inclusion criteria
Inclusion criteria: All neonates admitted to level III NICU will be screened for eligibility 1.Gestation equal to or more than 34 0/7 week post menstrual age by best obstetric estimate and a birth weight equal to or more than 2000 g 2.Age less than 28 days 3.On mechanical ventilation 4.Clinical diagnosis of PPHN 5.Entry criteria: Hypoxemic respiratory failure i.e. Oxygenation index (OI) equal to or more than 10 and less than 40 (OI equals mean airway pressure x FiO2) divided by PaO2 x (100). 6.Screening echocardiogram to assess the presence of PPHN (defined as evidence of right to left or bidirectional shunting) and to eliminate subjects with large left to right intracardiac or ductal shunting or significant congenital heart disease.
Exclusion criteria
Exclusion criteria: 1.Lethal congenital anomalies or obvious syndrome 2. Presence of congenital heart disease, congenital diaphragmatic hernia, lung hypoplasia syndromes), except: patent ductus arteriosus, patent foramen ovale, small atrial septal defect, or small ventricular septal defect 3. Bleeding diathesis (abnormal coagulation screen/platelet 10,0000/ mm3) 4. The presence of grade III or more grade of Intraventricular haemorrhage: Screening cranial ultrasound before randomization 5. Severe hypotension (mean blood pressure 35 mm Hg) or shock (heart rate 180 beats per minute, capillary refill time 3 second, urine output 0.5ml/kg/hour) unresponsive to medical management (>= 2 inotropes). 6. Hypoxic-ischemic encephalopathy undergoing therapeutic hypothermia 7. Evidence of renal impairment (Creatinine 1.5 mg/dl). 8. In the opinion of investigator, inappropriate for study for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in oxygenation indexTimepoint: at 48 hrs | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortalityTimepoint: 28 days of life;Systolic pulmonary artery pressureTimepoint: 48hrs;Length of hospital stayTimepoint: till discharge;Duration of mechanical ventilationTimepoint: 28 days;Mean blood pressureTimepoint: 24hr;Treatment failureTimepoint: 48 hrs;Change in OITimepoint: 24 hrs;Time to decrease in OITimepoint: 48 hrs;Adverse events- 1. Hypotension: -Hypotension requiring 2 or more inotropes for normalization of BP 2. Pulmonary hemorrhage 4. Any other adverse eventTimepoint: 48 hrs;Safety laboratory tests- complete blood count, AST, ALT, serum creatinineTimepoint: 48 hrs | — |
Countries
India
Contacts
Public ContactDr Rameshwar Prasad
All India Institute of Medical Sciences, Patna
Outcome results
None listed