Efficacy of Milrinone Plus Sildenafil in the Treatment of Neonates With Persistent Pulmonary Hypertension: A Single-Center, Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Sildenafil
- Conditions
- Persistent Pulmonary Hypertension of the Newborn
- Sponsor
- Muhammad Aamir Latif
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Change in pulmonary artery systolic pressure
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Neonates with persistent pulmonary hypertension (PPH) should be administered inhaled nitric oxide (iNO) and extracorporeal membrane oxygenation (ECMO), but these are not available in most resource-constrained settings like ours. This study was planned to compare the outcomes of Milrinone plus Sildenafil versus Sildenafil alone in the treatment of PPH in neonates.
Investigators
Muhammad Aamir Latif
Research Consultant
RESnTEC, Institute of Research
Eligibility Criteria
Inclusion Criteria
- •Patients of either gender
- •Aged between 1-28 days
- •Birth weight above 2000 grams
- •Diagnosed with persistent pulmonary hypertension (as per echocardiography)
Exclusion Criteria
- •Neonates having congenital heart defects (CHDs)
- •Congenital diaphragmatic hernia
- •Lung anomalies
- •History of any surgical intervention
Arms & Interventions
Sildenafil
Patients were given oral sildenafil at 2 mg per kg per day, 6-hourly, with an increment of 0.5 mg per kg per dose and a target maintenance dose of 2 mg per kg per dose every 6 hours by nasogastric tube.
Intervention: Sildenafil
Sildenafil + Milrinone
In this group, Milrinone was initiated at 0.5 ug per kg per minute using intravenous infusion through a syringe pump, and sildenafil was given in the same protocol mentioned for the Sildenafil Group.
Intervention: Sildenafil
Sildenafil + Milrinone
In this group, Milrinone was initiated at 0.5 ug per kg per minute using intravenous infusion through a syringe pump, and sildenafil was given in the same protocol mentioned for the Sildenafil Group.
Intervention: Milrinone
Outcomes
Primary Outcomes
Change in pulmonary artery systolic pressure
Time Frame: 72 hours
Efficacy was labeled yes if there was adecrease in pulmonary artery systolic pressure (PASP)