Efficacy of Milrinone With Sildenafil in Persistent Pulmonary Hypertension in Children

NCT06562036 | Completed

• 1 other identifier: DRAWAIS
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Persistent Pulmonary Hypertension of the Newborn

Outcome Measures

Primary Outcomes (1)

• Change in pulmonary artery systolic pressure

  Efficacy was labeled yes if there was adecrease in pulmonary artery systolic pressure (PASP)

  72 hours

Study Arms (2)

Sildenafil

EXPERIMENTAL

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.

Drug: Sildenafil

Sildenafil + Milrinone

EXPERIMENTAL

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.

Drug: Sildenafil; Drug: Milrinone

Interventions

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.

Sildenafil; Sildenafil + Milrinone

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.

Sildenafil + Milrinone

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients of either gender
• Aged between 1-28 days
• Birth weight above 2000 grams
• Diagnosed with persistent pulmonary hypertension (as per echocardiography)

You may not qualify if:

• Neonates having congenital heart defects (CHDs)
• Congenital diaphragmatic hernia
• Lung anomalies
• History of any surgical intervention

Sponsors & Collaborators

• Muhammad Aamir Latif: lead

Study Sites (1)

Children's Hospital and institute of Child Health

Multan, Punjab Province, 60000, Pakistan

Location

MeSH Terms

Conditions

Persistent Fetal Circulation Syndrome

Interventions

Sildenafil Citrate; Milrinone

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Amrinone; Aminopyridines; Amines; Pyridines

Study Officials

• Muhammad Awais, FCPS

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

  PRINCIPAL INVESTIGATOR

• Abdur Rehman, FCPS

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Consultant

Study Record Dates

• First Submitted: August 17, 2024
• First Posted: August 20, 2024
• Study Start: December 1, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)