Nitro Oxide Inhalation Continued With Sildenafil on Neonatal Persistent Pulmonary Hypertension

Third Military Medical University

Status: Unknown

Conditions: Persistent Pulmonary Hypertension of Newborn

Treatments: Drug: NO inhalation; Drug: NO inhalation continued with sildenafil

Study type: Interventional

Funder types: Other

Identifiers

NCT01373749

1991660

Details and patient eligibility

About

Nitro Oxide (NO) inhalation was recognized as an effect treatment of Neonatal Persistent Pulmonary Hypertension (PPHN), while the safety of NO long term application was under investigation. Several research suggested too much NO2 was generated in the lung after long term (> 72h) use of NO inhalation, which cause bad effects on PS production.

Sildenafil was proved to be effective to PPHN as NO. This medication has a similar clinical effect but need monitoring of blood pressure. The possible hypotension effect restrict the dosage of sildenafil, which limit the usage of sildenafil in severe PPHN. But we recommend sildenafil to The purpose of the study was to establish if NO continued with sildenafil has the same effect as single NO inhalation.

Enrollment: 40 estimated patients

Sex: All

Ages: Under 28 days old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:Diagnosed as PPHN in the NICU,primary disease:neonate respiratory distress syndrome,meconium aspiration syndrome of newborn,severe neonatal infectious pneumonia.

• Pulmonary artery pressure > 50mmHg
• mechanical ventilation over 48h
• primary OI(PO2/FiO2)<300
• difference of SpO2 between up and low limbs > 10%
• high FiO2 oxygen inhalation test: positive

Exclusion Criteria:

• congenital heart disease
• diaphragmatic hernia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups, including a placebo group

NOS

Experimental group

Description:

NO inhalation was performed in the first stage(\<48h) of PPHN, NO inhalation was replaced by sildenafil in the second stage(\>48h).

Treatment:

Drug: NO inhalation continued with sildenafil

NO

Placebo Comparator group

Description:

NO inhalation was performed during the whole treatment procedure of PPHN. There is no other methods given to treat PPHN during the therapy course.

Treatment:

Drug: NO inhalation