Nitro Oxide Inhalation Continued With Sildenafil on Neonatal Persistent Pulmonary Hypertension
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|ClinicalTrials.gov 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
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
- 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.
- 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.
- incidence of pulmonary disease;(chronic lung disease)
- incidence of brain injury. (Hypoxic-ischemic encephalopathy)
- Heart structure change(right ventricle enlarge)
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 ClinicalTrials.gov identifier (NCT number): NCT01373749
|Contact: Zhangxue Hu, MMfirstname.lastname@example.org|
|Department of Pediatrics,Daping hospital||Recruiting|
|Chongqing, Chongqing, China, 400042|
|Contact: Zhangxue Hu, MM 00862368757730 email@example.com|