Nitro Oxide Inhalation Continued With Sildenafil on Neonatal Persistent Pulmonary Hypertension
Compare of Continued Nitro Oxide Inhalation and Nitro Oxide Inhalation Continued With Oral Sildenafil on Treatment of Neonatal Persistent Pulmonary Hypertension
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 31, 2011
CompletedFirst Posted
Study publicly available on registry
June 15, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedJune 15, 2011
January 1, 2011
9 months
May 31, 2011
June 14, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
persistent normal pulmonary artery pressure
The pulmonary artery pressure returned back to a normal level(\<30mmHg) and last over 48 hours.
96 hours
Secondary Outcomes (1)
Recover without complication
1 month after therapy
Study Arms (2)
NOS
EXPERIMENTALNO inhalation was performed in the first stage(\<48h) of PPHN, NO inhalation was replaced by sildenafil in the second stage(\>48h).
NO
PLACEBO COMPARATORNO inhalation was performed during the whole treatment procedure of PPHN. There is no other methods given to treat PPHN during the therapy course.
Interventions
NO inhalation was performed as the only treatment for PPHN during the whole course.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- congenital heart disease
- diaphragmatic hernia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Pediatrics,Daping hospital
Chongqing, Chongqing Municipality, 400042, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 31, 2011
First Posted
June 15, 2011
Study Start
March 1, 2011
Primary Completion
December 1, 2011
Study Completion
March 1, 2012
Last Updated
June 15, 2011
Record last verified: 2011-01