Pulmonary DiseasePhase 2/3NO-BPDNCT01503801
Inhaled Nitric Oxide to Prevent and Treat Bronchopulmonary Dysplasia
A Phase 2/3 study testing Nitric Oxide and respiratory support in people with Pulmonary Disease, run by Fudan University at 1 site in China.
Trial summary
Inhaled nitric oxide in preterm babies with respiratory failure or ventilator dependence will: 1. decrease the incidence of Bronchopulmonary Dysplasia (BPD) or death 2. shorten the length of oxygen therapy and hospital stay ,reduce the cost of hospital stay without increasing adverse effect Read more about this study
- Who is it for?
- Ages 1 hour to 30 days
- Conditions the study is for
- Pulmonary Disease
- What is being tested?
- Nitric Oxide and respiratory support
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- May 2011to Dec 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- GA<=34w,less than 7 days of age,oxygenation index (OI) of more than 10 after being ventilated for more than 48 hours or surfactant therapy
- GA<=34w,between 7 to 30 days of age, requiring assisted ventilator or nasal continuous positive airway pressure for more than 2 days
Who cannot join
- lethal congenital anomalies or congenital heart disease (including an atrial septal defect larger than 1 cm and a ventricular septal defect larger than 2 mm)
- active pulmonary hemorrhage, unevaluated pneumothorax
- preexisting bilateral grade 3-4 intraventricular hemorrhage
- a platelet count <100*10^9/l
- an expected duration of ventilation of less than 48 hours
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
About this study
Official title: Inhaled Nitric Oxide to Prevent and Treat Bronchopulmonary Dysplasia in Preterm Infants
Inhaled nitric oxide in preterm babies with respiratory failure or ventilator dependence will:
- decrease the incidence of Bronchopulmonary Dysplasia (BPD) or death
- shorten the length of oxygen therapy and hospital stay ,reduce the cost of hospital stay without increasing adverse effect
Read the detailed description
Bronchopulmonary dysplasia remains a problem in neonatal intensive care unit (NICU) all over the world. This multicenter, non-randomized, unmasked clinical trial evaluate the efficacy of inhaled nitric oxide (iNO) in the treatment of the preterm infant with developing bronchopulmonary dysplasia.
Infants were followed until death or discharge to home. The trial will compare iNO therapy to conventional management strategies (including treatment with nasal continuous positive airway pressure (CPAP), surfactant and high frequency ventilation as adjuncts to iNO therapy) as the control.
During the initial dosing, iNO was started at 5 ppm and could be decreased to 1-2 ppm. The Infants would inhale NO until weaned. Infants will be monitored for signs of toxicity due to cumulated dosage of NO and its metabolites, such as methemoglobin, and nitrite and nitrate in blood and urine, and nitrogen dioxide in ventilator circuit to the patient.
- Conditions
- Pulmonary Disease
- Being tested
- Nitric Oxide, respiratory support
- Keywords
- Preterm neonates, Bronchopulmonary dysplasia, Chronic lung disease, Inhaled nitric oxide, Respiratory therapy
- Medical subject headings
- Lung Diseases, Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitric OxideDrug
Also called Nitrogen Monoxide, Endothelium Derived Relaxing Factor (EDRF)
The infants in experimental group will receive inhale nitric oxide initiated at 5 ppm for 24 h followed by 2 ppm for 6 days or until weaning off
respiratory supportDevice
Also called Nasal CPAP, Conventional mechanical ventilation, High frequency Oscillatory ventilation
Routine respiratory support.
| Study group | Role | What they receive |
|---|---|---|
| inhaled nitric oxide | Experimental | The preterm infants in the experimental group inhaled nitric oxide Receives: Drug: Nitric Oxide |
| oxygen | Active comparator | The preterm infants enrolled but subjected to routine respiratory support. Receives: Device: respiratory support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death or Bronchopulmonary Dysplasia
the incidence of death before discharge or BPD at 36 weeks post-conceptional age
Measured: Before discharge or at 36 weeks post-conceptional age
Secondary outcomes (5)
Intraventricular Hemorrhage Grade III and IV
the incidence of Intraventricular Hemorrhage Grade III and IV At 36 weeks post-conceptional age
Measured: At 36 weeks post-conceptional age
Days on assisted ventilation
Days on assisted ventilation before discharge
Measured: Before discharge
Length of oxygen therapy
Length of oxygen therapy before discharge
Measured: Before discharge
Retinopathy of prematurity
Retinopathy of prematurity before discharge
Measured: Before discharge
Cost of hospital and NICU stay
Medical cost of hospital and NICU stay
Measured: Before discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2012 (estimated)
- Study startMay 2011
- Primary completionSep 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Fudan University, Children's Hospital of Hebei Province, Shen-Zhen City Maternity and Child Healthcare Hospital, Hunan Children's Hospital, QuanZhou Women and Children's Hospital, The First Affiliated Hospital of Xiamen University, Xiamen Women's and Children's Hospital
- Responsible party
- Principal investigator, Bo Sun, Fudan University
- Investigators
- Bo Sun, Ph.D, Principal investigator, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01503801
- Sponsor's protocol ID
- FudanU
- Acronym
- NO-BPD
- Status last verified
- Jan 2013
- First submitted
- 19 Dec 2011
- Last updated
- 28 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Nitric Oxide to Prevent and Treat Bronchopulmonary Dysplasia in Preterm Infants
- ClinicalTrials.gov ID
- NCT01503801
- Acronym / sponsor ID
- NO-BPD / FudanU
- Conditions
- Pulmonary Disease
- Keywords
- Preterm neonates, Bronchopulmonary dysplasia, Chronic lung disease, Inhaled nitric oxide, Respiratory therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Children's Hospital of Fudan University, Children's Hospital of Hebei Province, Shen-Zhen City Maternity and Child Healthcare Hospital, Hunan Children's Hospital, QuanZhou Women and Children's Hospital, The First Affiliated Hospital of Xiamen University, Xiamen Women's and Children's Hospital
- Study start
- May 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 4 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Inhaled nitric oxide in preterm babies with respiratory failure or ventilator dependence will:
- decrease the incidence of Bronchopulmonary Dysplasia (BPD) or death
- shorten the length of oxygen therapy and hospital stay ,reduce the cost of hospital stay without increasing adverse effect
Detailed description
Bronchopulmonary dysplasia remains a problem in neonatal intensive care unit (NICU) all over the world. This multicenter, non-randomized, unmasked clinical trial evaluate the efficacy of inhaled nitric oxide (iNO) in the treatment of the preterm infant with developing bronchopulmonary dysplasia.
Infants were followed until death or discharge to home. The trial will compare iNO therapy to conventional management strategies (including treatment with nasal continuous positive airway pressure (CPAP), surfactant and high frequency ventilation as adjuncts to iNO therapy) as the control.
During the initial dosing, iNO was started at 5 ppm and could be decreased to 1-2 ppm. The Infants would inhale NO until weaned. Infants will be monitored for signs of toxicity due to cumulated dosage of NO and its metabolites, such as methemoglobin, and nitrite and nitrate in blood and urine, and nitrogen dioxide in ventilator circuit to the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inhaled nitric oxide | Experimental | Drug: Nitric OxideThe preterm infants in the experimental group inhaled nitric oxide |
| oxygen | Active comparator | Device: respiratory supportThe preterm infants enrolled but subjected to routine respiratory support. |
Who may qualify
- Ages
- 1 hour to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- GA<=34w,less than 7 days of age,oxygenation index (OI) of more than 10 after being ventilated for more than 48 hours or surfactant therapy
- GA<=34w,between 7 to 30 days of age, requiring assisted ventilator or nasal continuous positive airway pressure for more than 2 days
Key exclusion criteria (5 listed)
- lethal congenital anomalies or congenital heart disease (including an atrial septal defect larger than 1 cm and a ventricular septal defect larger than 2 mm)
- active pulmonary hemorrhage, unevaluated pneumothorax
- preexisting bilateral grade 3-4 intraventricular hemorrhage
- a platelet count <100*10^9/l
- an expected duration of ventilation of less than 48 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitric OxideAlso: Nitrogen Monoxide, Endothelium Derived Relaxing Factor (EDRF)The infants in experimental group will receive inhale nitric oxide initiated at 5 ppm for 24 h followed by 2 ppm for 6 days or until weaning off | Drug | inhaled nitric oxide |
| respiratory supportAlso: Nasal CPAP, Conventional mechanical ventilation, High frequency Oscillatory ventilationRoutine respiratory support. | Device | oxygen |
Primary outcome
Death or Bronchopulmonary Dysplasia
Time frame: Before discharge or at 36 weeks post-conceptional age
the incidence of death before discharge or BPD at 36 weeks post-conceptional age
5 secondary outcomes
Intraventricular Hemorrhage Grade III and IV
Time frame: At 36 weeks post-conceptional age
Days on assisted ventilation
Time frame: Before discharge
Length of oxygen therapy
Time frame: Before discharge
Retinopathy of prematurity
Time frame: Before discharge
Cost of hospital and NICU stay
Time frame: Before discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bo Sun, Ph.D principal investigator
Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Nitric Oxide and respiratory support in people with Pulmonary Disease, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death or Bronchopulmonary Dysplasia (time frame: Before discharge or at 36 weeks post-conceptional age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2013.