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

Viatris

Status and phase: Terminated; Phase 2

Conditions: Hypoxic Respiratory Failure; PPHN; Persistent Pulmonary Hypertension of the Newborn

Treatments: Drug: sildanefil

Study type: Interventional

Funder types: Industry

Identifiers

NCT01069861

A1481276

Details and patient eligibility

About

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

Full description

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.

Enrollment: 4 patients

Sex: All

Ages: 1 to 72 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

one

Experimental group

Treatment:

Drug: sildanefil