Nitro Oxide Inhalation Continued With Sildenafil on Neonatal Persistent Pulmonary Hypertension (NO)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Third Military Medical University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Natural Science Foundation of China
Information provided by:
Third Military Medical University
ClinicalTrials.gov Identifier:
NCT01373749
First received: May 31, 2011
Last updated: June 14, 2011
Last verified: January 2011
  Purpose

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 Intervention
Persistent Pulmonary Hypertension of Newborn
Drug: NO inhalation
Drug: NO inhalation continued with sildenafil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Third Military Medical University:

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


Secondary Outcome Measures:
  • Recover without complication [ Time Frame: 1 month after therapy ] [ Designated as safety issue: Yes ]

    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)


Estimated Enrollment: 40
Study Start Date: March 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   up to 28 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01373749

Contacts
Contact: Zhangxue Hu, MM 00862368757730 huzx1@163.com

Locations
China, Chongqing
Department of Pediatrics,Daping hospital Recruiting
Chongqing, Chongqing, China, 400042
Contact: Zhangxue Hu, MM    00862368757730    huzx1@163.com   
Sponsors and Collaborators
Third Military Medical University
National Natural Science Foundation of China
  More Information

No publications provided

Responsible Party: Dr.Hu.Zhangxue, Department of Pediatrics, Daping Hospital, Third Military Medical Universityof PLA,CHINA
ClinicalTrials.gov Identifier: NCT01373749     History of Changes
Other Study ID Numbers: 1991660
Study First Received: May 31, 2011
Last Updated: June 14, 2011
Health Authority: China: Ethics Committee

Keywords provided by Third Military Medical University:
PPHN
NO inhalation
Sildenafil
Treatment
Safety

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

ClinicalTrials.gov processed this record on August 01, 2014