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Bronchopulmonary DysplasiaPhase 2NCT00955487

Examining the Use of Non-Invasive Inhaled Nitric Oxide to Reduce Chronic Lung Disease in Premature Newborns

A Phase 2 study testing Inhaled Nitric Oxide (iNO) in people with Bronchopulmonary Dysplasia, run by University of Colorado, Denver at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Bronchopulmonary dysplasia (BPD) is a serious lung condition that affects premature newborns. The condition involves abnormal development of lung tissue and is characterized by inflammation and scarring in the lungs. Read more about this study

Who is it for?
Ages Up to 72 hours
Conditions the study is for
Bronchopulmonary Dysplasia
What is being tested?
Inhaled Nitric Oxide (iNO)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
124 participants
Where
6 sitesUnited States
Study dates
Jan 2007to Dec 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 Up to 72 hours
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Birth weight of 500-1250 grams and gestational age of less than 34 weeks
  • Age at enrollment is less than 72 hours
  • Supplemental oxygen or 21% requirement by nasal cannula or NCPAP only

Who cannot join

  • Presence of structural heart disease (other than patent ductus arteriosus, atrial septal defect less than 1 cm, or muscular ventricular septal defect less than 2 mm)
  • Presence of lethal congenital anomaly
  • Participating in another concurrent experimental study
  • Requires mechanical ventilation in the first 72 hours of life (patients are not excluded if they are intubated briefly but they must be extubated at the time of consent and study entry prior to 72 hours of life)

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Children's Hospital and University Colorado Hospital

    Aurora, Colorado, 80045

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35242

  • Anne and Robert H. Lurie Children's Hospital of Chicago and Northwestern Memorial Hospital

    Chicago, Illinois, 60614

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

  • Vanderbilt Children's Hospital

    Nashville, Tennessee, 37232

  • University of California San Diego

    San Diego, California, 92123

Other trials in United States

About this study

Bronchopulmonary dysplasia (BPD) is a serious lung condition that affects premature newborns. The condition involves abnormal development of lung tissue and is characterized by inflammation and scarring in the lungs. Treatment with inhaled nitric oxide (iNO) may reduce the incidence of BPD and another commonly associated condition called pulmonary hypertension, which is high blood pressure in the vessels carrying blood to the lungs.. This study will determine if early treatment with low-dose iNO reduces the incidence of BPD, pulmonary hypertension, and death in premature newborns.

Read the detailed description

BPD is a serious lung condition that primarily affects premature newborns and newborns with low birth weights. iNO has been proven to be a safe and effective treatment for pulmonary hypertension and hypoxemic respiratory failure-both of which are abnormal lung conditions-in full-term newborns. However, in babies born prematurely, the effects of iNO on lung function are not well defined. Also, previous studies have mainly examined whether iNO reduces the incidence of BPD in newborns who are on mechanical ventilation. However, intubation and mechanical ventilation of premature newborns is now increasingly being avoided, and non-invasive support, including the use of nasal continuous positive airway pressure (NCPAP), is being used. Early treatment with low-dose iNO may reduce the incidence of BPD in premature newborns who do not require mechanical ventilation and intubation after delivery. The purpose of this study is to determine if low-dose, non-invasive iNO reduces the risk of BPD, pulmonary hypertension, and death in premature newborns who do not require mechanical ventilation.

This study will enroll premature newborns who require extra oxygen but do not require intubation or mechanical ventilation for respiratory failure in the first 72 hours of life. Participants will be randomly assigned to receive low-dose, non-invasive iNO or nitrogen (placebo) during their hospital stay. While hospitalized, participants' heart rate, blood oxygen level breathing rate, blood pressure, and medications will be monitored, and blood collection will occur at various times. Monitoring will continue until participants are 30 weeks corrected gestational age or for at least 14 days if participants are born at 29 weeks or more. All participants will undergo an ultrasound of the head when they are 7 days, 28 days, and 36 weeks of age. They will undergo an echocardiogram, which is an ultrasound of the heart, at 7 and 21 days of age and 4 weeks before the original expected due date. A chest x-ray will be performed before hospital discharge, and a breathing status test will be performed either 4 weeks before participants' original expected due date or before hospital discharge. Follow-up study visits will occur at Years 1 and 2, and will include a physical examination and developmental and behavioral testing. Another echocardiogram will also be performed at the Year 1 visit.

Being tested
Inhaled Nitric Oxide (iNO), Nitrogen (placebo)
Keywords
Premature Newborns, Inhaled Nitric Oxide
Medical subject headings
Bronchopulmonary Dysplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inhaled Nitric Oxide (iNO)Drug

    iNO will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).

  • Nitrogen (placebo)Drug

    Nitrogen will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).

Study groups in NCT00955487
Study groupRoleWhat they receive
Inhaled Nitric Oxide (iNO)ExperimentalParticipants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Receives: Drug: Inhaled Nitric Oxide (iNO)
Nitrogen (placebo)Placebo comparatorParticipants will receive nitrogen (placebo) while in the hospital.
Receives: Drug: Nitrogen (placebo)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality

    Number of participants that developed bronchopulmonary dysplasia and/or that died

    Measured: Week 36 or earlier, if participants are discharged from the hospital

  2. Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality Stratified by Birth Weight

    Number of participants that developed bronchopulmonary dysplasia and/or that died, stratified by birth weight (grams)

    Measured: Randomization to discharge

Secondary outcomes (9)

  1. Severity of Bronchopulmonary Dysplasia (BPD)

    Assessment of the severity of BPD as defined by the oxygen reduction test

    Measured: 36 weeks corrected gestational age

  2. Need for Mechanical Ventilation

    Number of participants who required endotracheal intubation and mechanical ventilation

    Measured: Anytime after randomization up to 36 weeks corrected gestational age

  3. Total Ventilation Days

    Of those participants who required mechanical ventilation, the total number of days receiving ventilation

    Measured: After randomization up until hospital discharge

  4. Necrotizing Enterocolitis (NEC)

    Number of participants diagnosed with necrotizing enterocolitis

    Measured: After randomization through hospital discharge

  5. Symptomatic PDA Requiring Medical Treatment

    Number of participants with a symptomatic PDA that required medical treatment

    Measured: From randomization until discharge

  6. Symptomatic PDA Requiring Surgical Ligation

    Number of participants with symptomatic PDA that required surgical ligation

    Measured: Randomization through discharge

  7. Threshold Retinopathy of Prematurity (ROP)

    Threshold ROP defined as requiring interventional therapy

    Measured: Randomization to discharge

  8. Severe Intracranial Hemorrhage

    Number of participants that developed severe intracranial hemorrhage (grade 3-4)

    Measured: Randomization to discharge

  9. Sepsis

    Number of participants that developed sepsis

    Measured: Randomization to discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2009 (estimated)
  2. Study startJan 2007
  3. Primary completionJul 2014
  4. Study completionDec 2014

Resources

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
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00955487
Sponsor's protocol ID
06-0124
Other IDs
5P50HL084923, 5 P50 HL084923-030001
Status last verified
May 2017
First submitted
6 Aug 2009
Last updated
15 Jun 2017
Data monitoring committee
Yes

Publications

  • Kinsella JP, Cutter GR, Steinhorn RH, Nelin LD, Walsh WF, Finer NN, Abman SH. Noninvasive inhaled nitric oxide does not prevent bronchopulmonary dysplasia in premature newborns. J Pediatr. 2014 Dec;165(6):1104-1108.e1. doi: 10.1016/j.jpeds.2014.06.018. Epub 2014 Jul 22.

    PubMed 25063725

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Inhaled Nitric Oxide (iNO) in people with Bronchopulmonary Dysplasia, run by University of Colorado, Denver at 6 sites in United States.

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 3 inclusion and 4 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 15 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality (time frame: Week 36 or earlier, if participants are discharged from the hospital). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00955487, which also lists 1 linked publication.

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 15 Jun 2017; AzTrials last refreshed its copy on 8 Nov 2026.

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