Nitro Oxide Inhalation Continued With Sildenafil on Neonatal Persistent Pulmonary Hypertension

NCT ID: NCT01373749

Last Updated: 2011-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Persistent Pulmonary Hypertension of Newborn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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NOS

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

Group Type EXPERIMENTAL

NO inhalation continued with sildenafil

Intervention Type DRUG

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.

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.

Group Type PLACEBO_COMPARATOR

NO inhalation

Intervention Type DRUG

NO inhalation was performed as the only treatment for PPHN during the whole course.

Interventions

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NO inhalation

NO inhalation was performed as the only treatment for PPHN during the whole course.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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
Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Natural Science Foundation of China

OTHER_GOV

Sponsor Role collaborator

Third Military Medical University

OTHER

Sponsor Role lead

Responsible Party

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Department of Pediatrics, Daping Hospital, Third Military Medical Universityof PLA,CHINA

Locations

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Department of Pediatrics,Daping hospital

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhangxue Hu, MM

Role: CONTACT

00862368757730

Facility Contacts

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Zhangxue Hu, MM

Role: primary

00862368757730

Other Identifiers

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1991660

Identifier Type: -

Identifier Source: org_study_id

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