Efficacy of Milrinone With Sildenafil in Persistent Pulmonary Hypertension in Children

Not Applicable

Completed

• Conditions: Persistent Pulmonary Hypertension of the Newborn
• Interventions: Drug: Sildenafil; Drug: Milrinone

• Registration Number: NCT06562036
• Lead Sponsor: Muhammad Aamir Latif

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-01
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31
• Status Verified: 2024-08
• Study First Submitted: 2024-08-17
• Study First Submitted QC: 2024-08-17
• Study First Posted: 2024-08-20
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sildenafil	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.
Sildenafil + Milrinone	Sildenafil	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.
Sildenafil + Milrinone	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.

Primary Outcome Measures

Name	Time	Method
Change in pulmonary artery systolic pressure	72 hours	Efficacy was labeled yes if there was adecrease in pulmonary artery systolic pressure (PASP)

Trial Locations

Locations (1)

Children's Hospital and institute of Child Health; 🇵🇰 Multan, Punjab, Pakistan