Study To Investigate Safety And Efficacy Of Sildenafil In The Newborns With Persistent Pulmonary Hypertension (PPHN)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-11-30

Brief Summary

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Sildenafil is efficacious in newborns with persistent pulmonary hypertension and its use will reduce the need for inhaled nitric oxide.

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Detailed Description

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Letter to investigator dated 18 June 2012 that study was to be terminated. Study terminated due to evolved and widespread use of standard of care, relevance of study questioned. No safety reasons or issues.

Conditions

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PPHN Persistent Pulmonary Hypertension of the Newborn Hypoxic Respiratory Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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one

Group Type EXPERIMENTAL

sildanefil

Intervention Type DRUG

Intravenous sildenafil citrate will be administered as a loading dose of 0.1 mg/kg given over 30 minutes. This will be followed by a maintenance treatment consisting of an intravenous infusion of 0.03 mg/kg/hr. The duration of the infusion will be determined by the need of the individual patient, but will be reviewed at Day 7 if still ongoing, and will not continue past Day 14.

Interventions

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sildanefil

Intravenous sildenafil citrate will be administered as a loading dose of 0.1 mg/kg given over 30 minutes. This will be followed by a maintenance treatment consisting of an intravenous infusion of 0.03 mg/kg/hr. The duration of the infusion will be determined by the need of the individual patient, but will be reviewed at Day 7 if still ongoing, and will not continue past Day 14.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 72 hours of age; and \> or = to 34 weeks gestational age.
* Persistent Pulmonary Hypertension of the Newborn or Hypoxic respiratory failure associated with:

1. Idiopathic PPHN or
2. Meconium aspiration syndrome or
3. Sepsis or
4. Pneumonia
* Oxygenation Index (OI) \>15 and \<60 calculated

Exclusion Criteria

* Patients already receiving inhaled nitric oxide (iNO) on referral.
* Prior or immediate need for full Cardio Pulmonary Resuscitation or Extracorporeal Membrane Oxygenation (ECMO).
* Life threatening or lethal congenital anomaly.
* Large left to right intracardiac or ductal shunting (diagnosed from echocardiogram on admission to GOSH).
* Clinically significant active seizures as per clinical judgment.
* Bleeding diathesis as per clinical judgment

Minimum Eligible Age

1 Hour

Maximum Eligible Age

72 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No