Bronchopulmonary DysplasiaPhase 2NCT01268215
Pilot Study of Topical Steroid for Prevention of Chronic Lung Disease in Extremely Premature Infants.
A Phase 2 study testing Infasurf and Pulmicort in people with Bronchopulmonary Dysplasia, run by East Carolina University at 1 site in United States.
Trial summary
A Pilot study to evaluate the safety and the efficacy of endotracheal instillation of pulmonary surfactant, with or without topical steroid (Budesonide), as a prophylactic treatment for Bronchopulmonary Dysplasia (a form of chronic lung disease) in extremely low birth weight infants. Read more about this study
- Who is it for?
- Ages 24 to 28 weeks
- Conditions the study is for
- Bronchopulmonary Dysplasia
- What is being tested?
- Infasurf and Pulmicort
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Dec 2013
- Phase
- Phase 2
- 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 24 to 28 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birth weight 501-1000 g and ≤ 28 weeks gestational age
- Diagnosed as RDS requiring mechanical ventilation and surfactant therapy during the first 4 hours after birth
- Still ventilated on day 5-9 of life.
- An interval of at least 24 hours' duration between the last dose of indomethacin and the endotracheal instillation of study drug.
Who cannot join
- Congenital or chromosomal anomalies
- Occurrence of perinatal sepsis
- Use of intravenous steroids > 7 days
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
NICU-Pitt County Memorial Hospital
Greenville, North Carolina, 27834
About this study
Official title: The Effect of Endotracheal Instillation of Surfactant With and Without Budesonide on the Development of Bronchopulmonary Dysplasia in Ventilator-dependent, Extremely Low Birth Weight Infants: A Pilot Study
A Pilot study to evaluate the safety and the efficacy of endotracheal instillation of pulmonary surfactant, with or without topical steroid (Budesonide), as a prophylactic treatment for Bronchopulmonary Dysplasia (a form of chronic lung disease) in extremely low birth weight infants. Cytokines (a group of inflammatory mediators) are measured in the tracheal aspirate before and after instillation of the study drugs.
Read the detailed description
Bronchopulmonary Dysplasia (BPD) is still one of the most common complications of ventilated premature infants. Lung inflammation plays a major role in its pathogenesis. Systemic steroids can be given to control this inflammatory process but their widespread use is limited by their systemic side effects and concerns for long neurodevelopmental adverse sequelae. Delivering steroids by inhalation which has been proven to be effective in young infants with asthma has been shown to be unsatisfactory for ELBW infants with BPD. This may be due to the fact that current delivery devices do not meet the requirements of the specific anatomical and physiologic characteristics of the airways and breathing patterns in this special group of patients. A novel approach to facilitate delivery directly to the lungs, thereby avoiding systemic concerns has been demonstrated in a recent study in which budesonide ( a topical steroid) was given to ventilated preterm infants using surfactant as a vehicle.
- Conditions
- Bronchopulmonary Dysplasia
- Being tested
- Infasurf, Pulmicort, Sham
- Keywords
- Bronchopulmonary Dysplasia, Budesonide, Infasurf
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfasurfDrug
Also called Calfactant
Endotracheal instillation of Infasurf once per week for three weeks
PulmicortDrug
Also called Budesonide
Endotracheal instillation, once per week for three weeks
ShamOther
Also called Air Sham
None instilled through the endotracheal tube
| Study group | Role | What they receive |
|---|---|---|
| A (two study drugs group) | Experimental | The standard management + two study drugs (endotracheal instillation of a mixture containing budesonide and Infasurf) Receives: Drug: Infasurf; Drug: Pulmicort |
| B (one study drug group) | Active comparator | The standard management + one study drug (endotracheal instillation of Infasurf only). Receives: Drug: Infasurf |
| C (no study drug group) | Sham comparator | The standard management only. Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the effect of surfactant with and without Budesonide on the development of BPD in ELBW infants.
The main goal of the study is to determine whether endotracheal instillation of surfactant (Infasurf) with or without potent topical steroid (Budesonide) reduces the development of Bronchopulmonary Dysplasia (BPD) in Extremely Low Birth Weight (ELBW) infants at high risk of BPD.
Measured: Supplemental oxygen requirement at 36 weeks' postmenstrual age (PMA)
Secondary outcomes (1)
To measure the effect of surfactant with and without Budesonide on the inflammatory cytokines in tracheal aspirates.
Tracheal aspirate samples will be collected before instillation of each dose of the study drug, 7 days after the last dose if the infant is still intubated, and prior to elective extubation regardless of when extubation occurs. Tracheal aspirate samples will be obtained from the control (standard management) group in the same way and using the same time frame as the treatment groups
Measured: The measurement of cytokines in tracheal aspirate samples will be done at the end of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2010 (estimated)
- Study startJul 2010
- Primary completionJun 2012 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Investigators
- Waleed M Maamoun, MD, Principal investigator, Pitt County Memorial Hospital/Brody School of Medicine at East Carolina UniversityJames Cummings, MD, Study director, Pitt County Memorial Hospital/Brody School of Medicine at East Carolina UniversityScott MacGilvray, MD, Study chair, Pitt County Memorial Hospital/Brody School of Medicine at East Carolina UniversityKarl Kaminski, RRT-NPS, Study chair, Pitt County Memorial Hospital/Brody School of Medicine at East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01268215
- Sponsor's protocol ID
- UMCIRB # 10-0250
- Status last verified
- Jul 2010
- First submitted
- 28 Dec 2010
- Last updated
- 29 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Endotracheal Instillation of Surfactant With and Without Budesonide on the Development of Bronchopulmonary Dysplasia in Ventilator-dependent, Extremely Low Birth Weight Infants: A Pilot Study
- ClinicalTrials.gov ID
- NCT01268215
- Acronym / sponsor ID
- UMCIRB # 10-0250
- Conditions
- Bronchopulmonary Dysplasia
- Keywords
- Bronchopulmonary Dysplasia, Budesonide, Infasurf
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 29 Dec 2010 (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.
A Pilot study to evaluate the safety and the efficacy of endotracheal instillation of pulmonary surfactant, with or without topical steroid (Budesonide), as a prophylactic treatment for Bronchopulmonary Dysplasia (a form of chronic lung disease) in extremely low birth weight infants. Cytokines (a group of inflammatory mediators) are measured in the tracheal aspirate before and after instillation of the study drugs.
Detailed description
Bronchopulmonary Dysplasia (BPD) is still one of the most common complications of ventilated premature infants. Lung inflammation plays a major role in its pathogenesis. Systemic steroids can be given to control this inflammatory process but their widespread use is limited by their systemic side effects and concerns for long neurodevelopmental adverse sequelae. Delivering steroids by inhalation which has been proven to be effective in young infants with asthma has been shown to be unsatisfactory for ELBW infants with BPD. This may be due to the fact that current delivery devices do not meet the requirements of the specific anatomical and physiologic characteristics of the airways and breathing patterns in this special group of patients. A novel approach to facilitate delivery directly to the lungs, thereby avoiding systemic concerns has been demonstrated in a recent study in which budesonide ( a topical steroid) was given to ventilated preterm infants using surfactant as a vehicle.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A (two study drugs group) | Experimental | Drug: Infasurf, Drug: PulmicortThe standard management + two study drugs (endotracheal instillation of a mixture containing budesonide and Infasurf) |
| B (one study drug group) | Active comparator | Drug: InfasurfThe standard management + one study drug (endotracheal instillation of Infasurf only). |
| C (no study drug group) | Sham comparator | Other: ShamThe standard management only. |
Who may qualify
- Ages
- 24 to 28 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Birth weight 501-1000 g and ≤ 28 weeks gestational age
- Diagnosed as RDS requiring mechanical ventilation and surfactant therapy during the first 4 hours after birth
- Still ventilated on day 5-9 of life.
- An interval of at least 24 hours' duration between the last dose of indomethacin and the endotracheal instillation of study drug.
Key exclusion criteria (3 listed)
- Congenital or chromosomal anomalies
- Occurrence of perinatal sepsis
- Use of intravenous steroids > 7 days
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 |
|---|---|---|
| InfasurfAlso: CalfactantEndotracheal instillation of Infasurf once per week for three weeks | Drug | A (two study drugs group), B (one study drug group) |
| PulmicortAlso: BudesonideEndotracheal instillation, once per week for three weeks | Drug | A (two study drugs group) |
| ShamAlso: Air ShamNone instilled through the endotracheal tube | Other | C (no study drug group) |
Primary outcome
To measure the effect of surfactant with and without Budesonide on the development of BPD in ELBW infants.
Time frame: Supplemental oxygen requirement at 36 weeks' postmenstrual age (PMA)
The main goal of the study is to determine whether endotracheal instillation of surfactant (Infasurf) with or without potent topical steroid (Budesonide) reduces the development of Bronchopulmonary Dysplasia (BPD) in Extremely Low Birth Weight (ELBW) infants at high risk of BPD.
1 secondary outcome
To measure the effect of surfactant with and without Budesonide on the inflammatory cytokines in tracheal aspirates.
Time frame: The measurement of cytokines in tracheal aspirate samples will be done at the end of the study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2010.
Related trials for Bronchopulmonary Dysplasia
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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.
Waleed M Maamoun, MD principal investigator
Pitt County Memorial Hospital/Brody School of Medicine at East Carolina University
James Cummings, MD study director
Pitt County Memorial Hospital/Brody School of Medicine at East Carolina University
Scott MacGilvray, MD study chair
Pitt County Memorial Hospital/Brody School of Medicine at East Carolina 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 study testing Infasurf and Pulmicort in people with Bronchopulmonary Dysplasia, run by East Carolina University at 1 site 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 29 Dec 2010. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Waleed Maamoun, MD (1-252-744-3945, maamounw@ecu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure the effect of surfactant with and without Budesonide on the development of BPD in ELBW infants. (time frame: Supplemental oxygen requirement at 36 weeks' postmenstrual age (PMA)). 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 29 Dec 2010.