Persistent Fetal Circulation Syndrome Clinical Trial
Official title:
Early Combined Use of Inhaled Nitric Oxide and Oral Sildenafil on the Outcome of Pulmonary Hypertension in New Born Infants
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.
PPHN is characterized by hyper reactivity of the muscle layer in pulmonary arterioles and
right to left shunt across the ductus arteriosus and the foramen ovale in the absence of
structural heart defects. It could also include right ventricle dysfunction in many cases.
The reported incidence of this disease is 0.43 to 6.8/1000 live new born infants with a
mortality of 10-20%.
The main objective of therapy in PPHN is to reduce pulmonary vascular resistance. To this
purpose, inhaled nitric oxide has been used in developed and several under developed
countries. However 30-40% of these patients do not respond to this therapy. Extra corporeal
membrane oxygenation is also useful but is an invasive therapy in PPHN with serious adverse
effects reported. Recently Sildenafil has been evaluated as an alternative or adjunctive
pulmonary vasodilator. It inhibits phosphodiesterase type 5 and elevates the concentration
of cyclic guanosine monophosphate in the muscle cells of pulmonary vessels, which in turn
decreases pulmonary vascular resistance.
The FDA in the USA has recently approved the use of Sildenafil for use in adults with PPHN.
Recently 3 clinical trials have evaluated Sildenafil versus Placebo or control in newborns
with PPHN,all of them showing a significant improvement in oxygenation index, decreased
mortality and reduced risk of rebounds after discontinuing iNO. The use of Sildenafil in
treating PPHN secondary to Chronic lung disease in older infants had been receiving
significant attention over the last few years.
At HMC, Women's hospital, the number of deliveries average 15,000 to 16,000 per year with an
admission rate to the NICU of about 10%. The number of PPHN cases admitted to our NICU
ranges between 14-20 cases per year.
In this study the investigators plan to compare the effectiveness of the use of early
combined Sildenafil and iNO in newborns with PPHN and or hypoxemic respiratory failure and
whether it would improve oxygenation, decrease the time spent in mechanical ventilation and
prevent rebound hypoxic episodes.
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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