Respiratory Distress SyndromePhase 4NCT00883532
Prevention of Chronic Lung Disease (CLD) in Preterm Infants
A Phase 4 study testing budesonide in people with Respiratory Distress Syndrome and Chronic Lung Disease of Prematurity, run by China Medical University, China at 1 site in China.
Trial summary
Pulmonary inflammation plays an important role in the early development of CLD. Postnatal glucocorticoids have been shown effective in the prevention or treatment of CLD with various success. However, systemic glucocorticoid therapy often associated with various short term and long term complications. Read more about this study
- Who is it for?
- Ages 30 minutes to 4 hours
- Conditions the study is for
- Respiratory Distress Syndrome, Chronic Lung Disease of Prematurity
- What is being tested?
- budesonide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Apr 2009to Apr 2013
- Phase
- Phase 4
- 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 30 minutes to 4 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infant with birth weight between 500-1500 gram
- Severe respiratory distress syndrome and requires mechanical ventilation with FIO2 > 60% shortly after birth
Who cannot join
- Severe congenital anomalities
- Lethal cardiopulmonary status at birth
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China Medical University
Taichung, Taiwan
Tsu F Yeh, M.D., 886-4-2203-4150, tfyeh@mail.ncku.edu.tw
Yu C Pan, BS, 886-4-2203-4150, yuchenpanpan@yahoo.com.tw
About this study
Official title: Prevention of Chronic Lung Disease (CLD) in Preterm Infants -A New Therapeutic Regimen
Pulmonary inflammation plays an important role in the early development of CLD. Postnatal glucocorticoids have been shown effective in the prevention or treatment of CLD with various success. However, systemic glucocorticoid therapy often associated with various short term and long term complications. Therefore, modification of the therapeutic regimen is needed. Inhaled steroid, including inhaled budesonide,have been tried but the results are essentially unsuccessful, most likely due to small airways that the inhaled steroid reaching to the peripheral lungs are limited and unpredictable. Direct instillation of budesonide into the airway has also shown to be ineffective, possibly due to poor distribution of steroid in the lungs.
The investigators hypothesize that intratracheal instillation of budesonide, a strong tropical steroid, using surfactant as vehicle would facilitate the delivery of budesonide to the lung periphery and would inhibit lung inflammation and improve the pulmonary outcome. The result of our pilot study (Pediatrics, 2008) indicated this high possibility.
Read the detailed description
After informed consent is obtained, infant will be randomly assigned to two groups based on a double-blind design. Group I will receive surfactant and budesonide and GII will receive surfactant and air as control through endotracheal route. Therapy will be given every 8 hours until the infant require FIO2 < 30% or is extubated. The end point of assessment is the combined incidence of CLD and death judged at 36 weeks postconceptional age and the long term neurological and cognitive function at 2-3 years.
The incidence of CLD and death in the selective group of infant is about 60%. Using this 60% incidence in the placebo group and expected 40% (33% improvement) in the treated group, 130 infants in each group is needed to detected a difference, permitting a 5% chance of type I error and 10% chance of type II error. The total safe target number will be 300; 150 in each group. A collaborative study is therefore proposed. The primary outcome to be assessed is the combined incidence of CLD and death. The secondary outcome to be assessed is short term and long term side effects.
- Being tested
- budesonide, surfactant and air (placebo)
- Keywords
- Preterm infant, Respiratory distress syndrome, chronic lung disease, budesonide, surfactant
- Medical subject headings
- Respiratory Distress Syndrome, Bronchopulmonary Dysplasia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
budesonideDrug
Also called pulmicort
budesonide, 0.25 mg/Kg/dose every 8 hours until the infant requires FIO2 < 30% or is extubated
surfactant and air (placebo)Drug
Also called survanta
receive surfactant and air as control through endotracheal route
| Study group | Role | What they receive |
|---|---|---|
| budesonide | Experimental | The treatment group will receive surfactant and budesonide. Receives: Drug: budesonide |
| surfactant and air | Placebo comparator | The placebo group will receive surfactant and air as control. Receives: Drug: surfactant and air (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic lung disease morbidity among the survival
Measured: 36 postconceptional weeks
Secondary outcomes (1)
Neurodevelopment
Measured: 2 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2012 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress SyndromeStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital, Taipei Medical University Hospital, Cathay General Hospital, Chang Gung Memorial Hospital
- Investigators
- Tsu F Yeh, M.D., Principal investigator, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00883532
- Sponsor's protocol ID
- Yeh 2009 (CMU)
- Other IDs
- NHRI
- Status last verified
- Apr 2009
- First submitted
- 15 Apr 2009
- Last updated
- 8 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yeh TF, Lin HC, Chang CH, Wu TS, Su BH, Li TC, Pyati S, Tsai CH. Early intratracheal instillation of budesonide using surfactant as a vehicle to prevent chronic lung disease in preterm infants: a pilot study. Pediatrics. 2008 May;121(5):e1310-8. doi: 10.1542/peds.2007-1973. Epub 2008 Apr 21.
PubMed 18426851Yeh TF, Chen CM, Wu SY, Husan Z, Li TC, Hsieh WS, Tsai CH, Lin HC. Intratracheal Administration of Budesonide/Surfactant to Prevent Bronchopulmonary Dysplasia. Am J Respir Crit Care Med. 2016 Jan 1;193(1):86-95. doi: 10.1164/rccm.201505-0861OC.
PubMed 26351971
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Chronic Lung Disease (CLD) in Preterm Infants -A New Therapeutic Regimen
- ClinicalTrials.gov ID
- NCT00883532
- Acronym / sponsor ID
- Yeh 2009 (CMU)
- Keywords
- Preterm infant, Respiratory distress syndrome, chronic lung disease, budesonide, surfactant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital, Taipei Medical University Hospital, Cathay General Hospital, Chang Gung Memorial Hospital
- Study start
- Apr 2009
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 17 Apr 2009 (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.
Pulmonary inflammation plays an important role in the early development of CLD. Postnatal glucocorticoids have been shown effective in the prevention or treatment of CLD with various success. However, systemic glucocorticoid therapy often associated with various short term and long term complications. Therefore, modification of the therapeutic regimen is needed. Inhaled steroid, including inhaled budesonide,have been tried but the results are essentially unsuccessful, most likely due to small airways that the inhaled steroid reaching to the peripheral lungs are limited and unpredictable. Direct instillation of budesonide into the airway has also shown to be ineffective, possibly due to poor distribution of steroid in the lungs.
The investigators hypothesize that intratracheal instillation of budesonide, a strong tropical steroid, using surfactant as vehicle would facilitate the delivery of budesonide to the lung periphery and would inhibit lung inflammation and improve the pulmonary outcome. The result of our pilot study (Pediatrics, 2008) indicated this high possibility.
Detailed description
After informed consent is obtained, infant will be randomly assigned to two groups based on a double-blind design. Group I will receive surfactant and budesonide and GII will receive surfactant and air as control through endotracheal route. Therapy will be given every 8 hours until the infant require FIO2 < 30% or is extubated. The end point of assessment is the combined incidence of CLD and death judged at 36 weeks postconceptional age and the long term neurological and cognitive function at 2-3 years.
The incidence of CLD and death in the selective group of infant is about 60%. Using this 60% incidence in the placebo group and expected 40% (33% improvement) in the treated group, 130 infants in each group is needed to detected a difference, permitting a 5% chance of type I error and 10% chance of type II error. The total safe target number will be 300; 150 in each group. A collaborative study is therefore proposed. The primary outcome to be assessed is the combined incidence of CLD and death. The secondary outcome to be assessed is short term and long term side effects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| budesonide | Experimental | Drug: budesonideThe treatment group will receive surfactant and budesonide. |
| surfactant and air | Placebo comparator | Drug: surfactant and air (placebo)The placebo group will receive surfactant and air as control. |
Who may qualify
- Ages
- 30 minutes to 4 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infant with birth weight between 500-1500 gram
- Severe respiratory distress syndrome and requires mechanical ventilation with FIO2 > 60% shortly after birth
Key exclusion criteria (2 listed)
- Severe congenital anomalities
- Lethal cardiopulmonary status at birth
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 |
|---|---|---|
| budesonideAlso: pulmicortbudesonide, 0.25 mg/Kg/dose every 8 hours until the infant requires FIO2 < 30% or is extubated | Drug | budesonide |
| surfactant and air (placebo)Also: survantareceive surfactant and air as control through endotracheal route | Drug | surfactant and air |
Primary outcome
Chronic lung disease morbidity among the survival
Time frame: 36 postconceptional weeks
1 secondary outcome
Neurodevelopment
Time frame: 2 years of age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2012.
- Background: PubMed 18426851Yeh TF, Lin HC, Chang CH, Wu TS, Su BH, Li TC, Pyati S, Tsai CH. Early intratracheal instillation of budesonide using surfactant as a vehicle to prevent chronic lung disease in preterm infants: a pilot study. Pediatrics. 2008 May;121(5):e1310-8. doi: 10.1542/peds.2007-1973. Epub 2008 Apr 21.
- Derived from this study: PubMed 26351971Yeh TF, Chen CM, Wu SY, Husan Z, Li TC, Hsieh WS, Tsai CH, Lin HC. Intratracheal Administration of Budesonide/Surfactant to Prevent Bronchopulmonary Dysplasia. Am J Respir Crit Care Med. 2016 Jan 1;193(1):86-95. doi: 10.1164/rccm.201505-0861OC.
- click here for more information about the study; prevention of chronic lung disease in preterm infants--a new therapeutic regimenLink provided by the sponsor.
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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.
Tsu F Yeh, M.D. principal investigator
China Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing budesonide in people with Respiratory Distress Syndrome and Chronic Lung Disease of Prematurity, run by China Medical University, China 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 2 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 8 Aug 2012. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Tsu F Yeh, M.D. (886-4-2203-4150, tfyeh@mail.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic lung disease morbidity among the survival (time frame: 36 postconceptional weeks). 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 NCT00883532, which also lists 2 linked publications.
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 8 Aug 2012.