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Nitro Oxide Inhalation Continued With Sildenafil on Neonatal Persistent Pulmonary Hypertension

Primary Purpose

Persistent Pulmonary Hypertension of Newborn

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
NO inhalation
NO inhalation continued with sildenafil
Sponsored by
Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Persistent Pulmonary Hypertension of Newborn focused on measuring PPHN, NO inhalation, Sildenafil, Treatment, Safety

Eligibility Criteria

undefined - 28 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Pediatrics,Daping hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NOS

NO

Arm Description

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

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

Outcomes

Primary Outcome Measures

persistent normal pulmonary artery pressure
The pulmonary artery pressure returned back to a normal level(<30mmHg) and last over 48 hours.

Secondary Outcome Measures

Recover without complication
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)

Full Information

First Posted
May 31, 2011
Last Updated
June 14, 2011
Sponsor
Third Military Medical University
Collaborators
National Natural Science Foundation of China
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1. Study Identification

Unique Protocol Identification Number
NCT01373749
Brief Title
Nitro Oxide Inhalation Continued With Sildenafil on Neonatal Persistent Pulmonary Hypertension
Official Title
Compare of Continued Nitro Oxide Inhalation and Nitro Oxide Inhalation Continued With Oral Sildenafil on Treatment of Neonatal Persistent Pulmonary Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
March 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Third Military Medical University
Collaborators
National Natural Science Foundation of China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Pulmonary Hypertension of Newborn
Keywords
PPHN, NO inhalation, Sildenafil, Treatment, Safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NOS
Arm Type
Experimental
Arm Description
NO inhalation was performed in the first stage(<48h) of PPHN, NO inhalation was replaced by sildenafil in the second stage(>48h).
Arm Title
NO
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
NO inhalation
Intervention Description
NO inhalation was performed as the only treatment for PPHN during the whole course.
Intervention Type
Drug
Intervention Name(s)
NO inhalation continued with sildenafil
Intervention Description
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.
Primary Outcome Measure Information:
Title
persistent normal pulmonary artery pressure
Description
The pulmonary artery pressure returned back to a normal level(<30mmHg) and last over 48 hours.
Time Frame
96 hours
Secondary Outcome Measure Information:
Title
Recover without complication
Description
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)
Time Frame
1 month after therapy

10. Eligibility

Sex
All
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhangxue Hu, MM
Phone
00862368757730
Email
huzx1@163.com
Facility Information:
Facility Name
Department of Pediatrics,Daping hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhangxue Hu, MM
Phone
00862368757730
Email
huzx1@163.com

12. IPD Sharing Statement

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Nitro Oxide Inhalation Continued With Sildenafil on Neonatal Persistent Pulmonary Hypertension

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