Efficacy of Milrinone With Sildenafil in Persistent Pulmonary Hypertension in Children

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.

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Key information

Conditions

Persistent Pulmonary Hypertension of the Newborn Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hypertension, Pulmonary Infant, Newborn, Diseases Lung Diseases Persistent Fetal Circulation Syndrome Respiratory Tract Diseases

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital and institute of Child Health

Multan, Punjab Province, 60000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sildenafil

Drug

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.

Milrinone

Drug

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 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)

Sponsors and collaborators

Lead sponsor

Muhammad Aamir Latif

Other

Registry information

Official study title

Efficacy of Milrinone Plus Sildenafil in the Treatment of Neonates With Persistent Pulmonary Hypertension: A Single-Center, Randomized Controlled Trial

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Aug 20, 2024
Registry last updated: Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed