Sildenofil in Persistent Pulmonary Hypertension in Newborns

• Status: Unknown status
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study hopes to evaluate the effectiveness of early combined use of Sildenafil and nitric oxide (iNO) in newborns with Persistent pulmonary hypertension (PPHN) and or hypoxemic respiratory failure and assess whether this would improve oxygenation, improve time on mechanical ventilation for these babies and also prevent rebound hypoxic episodes.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hamad Medical Corporation
• Treatments: Sildenafil Citrate

Criteria

Inclusion Criteria:

1. Newborn infants of post natal age less than 48 hours

2. Gestational age equal to or more than 34 weeks

3. Oxygen index of more than or equal to 20 (moderately ill infants)

4. Radiological, clinical and biochemical evidence of acute hypoxic respiratory failure

5. Surfactant therapy has been established when indicated

6. Presence of arterial line

Exclusion Criteria:

1. Congenital diaphragmatic hernia

2. Major congenital abnormalities

3. Significant congenital heart disease

4. Cyanotic congenital heart disease