Persistent Pulmonary Hypertension of the Newborn
Conditions
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.
Interventions
DRUGSildenafil
Patients were given oral sildenafil as 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 hour by nasogastric tube.
DRUGMilrinone
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.
Sponsors
Muhammad Aamir Latif
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 28 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pulmonary artery systolic pressure | 72 hours | Efficacy was labeled yes if there was adecrease in pulmonary artery systolic pressure (PASP) |
Countries
Pakistan
Outcome results
None listed