Efficacy of Milrinone With Sildenafil in Persistent Pulmonary Hypertension in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Persistent Pulmonary Hypertension of the Newborn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Sildenafil

Intervention Type 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 + 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.

Group Type EXPERIMENTAL

Sildenafil

Intervention Type 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

Intervention Type 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.

Interventions

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Sildenafil

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.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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