Efficacy of Milrinone With Sildenafil in Persistent Pulmonary Hypertension in Children

Muhammad Aamir Latif

Status: Completed

Conditions: Persistent Pulmonary Hypertension of the Newborn

Treatments: Drug: Milrinone; Drug: Sildenafil

Study type: Interventional

Funder types: Other

Identifiers

NCT06562036

DRAWAIS

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 1 to 28 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Sildenafil

Experimental group

Description:

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.

Treatment:

Drug: Sildenafil

Sildenafil + Milrinone

Experimental group

Description:

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.

Treatment:

Drug: Sildenafil

Drug: Milrinone