Nitro Oxide Inhalation Continued With Sildenafil on Neonatal Persistent Pulmonary Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01373749
Recruitment Status : Unknown
Verified January 2011 by Third Military Medical University.
Recruitment status was:  Recruiting
First Posted : June 15, 2011
Last Update Posted : June 15, 2011
National Natural Science Foundation of China
Information provided by:
Third Military Medical University

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Persistent Pulmonary Hypertension of Newborn Drug: NO inhalation Drug: NO inhalation continued with sildenafil Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Compare of Continued Nitro Oxide Inhalation and Nitro Oxide Inhalation Continued With Oral Sildenafil on Treatment of Neonatal Persistent Pulmonary Hypertension
Study Start Date : March 2011
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : March 2012

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Arm Intervention/treatment
Experimental: NOS
NO inhalation was performed in the first stage(<48h) of PPHN, NO inhalation was replaced by sildenafil in the second stage(>48h).
Drug: NO inhalation continued with sildenafil
NO inhalation was performed as the primary treatment for PPHN in the first 48 hours, NO inhalation will be replaced by sildenafil after 48 hours of therapy.

Placebo Comparator: NO
NO inhalation was performed during the whole treatment procedure of PPHN. There is no other methods given to treat PPHN during the therapy course.
Drug: NO inhalation
NO inhalation was performed as the only treatment for PPHN during the whole course.

Primary Outcome Measures :
  1. persistent normal pulmonary artery pressure [ Time Frame: 96 hours ]
    The pulmonary artery pressure returned back to a normal level(<30mmHg) and last over 48 hours.

Secondary Outcome Measures :
  1. Recover without complication [ Time Frame: 1 month after therapy ]

    To ensure the safety of the therapies, brain and lung complications of the baby after PPHN is going to be observed 1 month after birth.

    1. incidence of pulmonary disease;(chronic lung disease)
    2. incidence of brain injury. (Hypoxic-ischemic encephalopathy)
    3. Heart structure change(right ventricle enlarge)

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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01373749

Contact: Zhangxue Hu, MM 00862368757730

China, Chongqing
Department of Pediatrics,Daping hospital Recruiting
Chongqing, Chongqing, China, 400042
Contact: Zhangxue Hu, MM    00862368757730   
Sponsors and Collaborators
Third Military Medical University
National Natural Science Foundation of China

Responsible Party: Dr.Hu.Zhangxue, Department of Pediatrics, Daping Hospital, Third Military Medical Universityof PLA,CHINA Identifier: NCT01373749     History of Changes
Other Study ID Numbers: 1991660
First Posted: June 15, 2011    Key Record Dates
Last Update Posted: June 15, 2011
Last Verified: January 2011

Keywords provided by Third Military Medical University:
NO inhalation

Additional relevant MeSH terms:
Hypertension, Pulmonary
Respiratory Aspiration
Persistent Fetal Circulation Syndrome
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Pathologic Processes
Infant, Newborn, Diseases
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents