Respiratory Distress SyndromePhase 4NCT03275415
Intratracheal Budesonide/Surfactant Prevents BPD
A Phase 4 study testing budesonide and Saline in people with Respiratory Distress Syndrome and Bronchopulmonary Dysplasia, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
A double-blind study includes: 1) birth Wt 500-1499 gm, 2) respiratory distress shortly after birth and requires resuscitation 3) failure to NCPAP within 4 hrs after birth, defined as: a) FIO2 ≥ 0.30, pressure > 5cmH2O b) severe retraction c) apnea d) PCO2 ≥ 60 mmHg. Read more about this study
- Who is it for?
- Ages 30 minutes to 4 hours
- Conditions the study is for
- Respiratory Distress Syndrome, Bronchopulmonary Dysplasia
- What is being tested?
- budesonide and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 310 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2019to 30 Jun 2022
- 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
- 1) birth Wt 500-1499 gm, 2) respiratory distress shortly after birth and requires resuscitation, 3) failure to NCPAP within 4 hrs after birth, defined as: a) FIO2 ≥ 0.30, pressure > 5 cmH2O b) severe retraction c) apnea d) PCO2 ≥ 60 mmHg.
Who cannot join
- 1) lethal cardiopulmonary status, 2) severe congenital anomalies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Routine Administration of Surfactant/Budesonide to Prevent BPD in VLBW With RDS-A Double Blind Study
A double-blind study includes: 1) birth Wt 500-1499 gm, 2) respiratory distress shortly after birth and requires resuscitation 3) failure to NCPAP within 4 hrs after birth, defined as: a) FIO2 ≥ 0.30, pressure > 5cmH2O b) severe retraction c) apnea d) PCO2 ≥ 60 mmHg. Exclusion criteria: 1) lethal cardiopulmonary status 2) severe congenital anomalies.
Given the COVID19 pandemics, the recruitment became difficult. Under the consideration of scientific and practical consideration, we therefore determine to have a sample of 300, (150 in each group), fulfill the criteria of type I error 0.05, type II error 0.10, power 90% and with an expectation of 30 % improvement of primary outcome (from 60 % in control group to 40 % in the intervention group as original presumed).Appropriate amount of placebo will be used as it does not affect the biophysical property of curosurf (PAS abstract 2017 San Francisco). Primary outcome of study is death or BPD defined by NICHD criteria. Follow up study of neuromotor and cognitive function and pulmonary states will be done at 1-2 years of corrected age.
Read the detailed description
A double-blind study will be conducted in 7 tertiary centers. Inclusion criteria are: 1) birth Wt 500-1499 gm, 2) respiratory distress shortly after birth and requires resuscitation 3) failure to NCPAP within 4 hrs after birth, defined as: a) FIO2 ≥ 0.30, pressure > 5cmH2O b) severe retraction c) apnea d) PCO2 ≥ 60 mmHg. Exclusion criteria: 1) lethal cardiopulmonary status 2) severe congenital anomalies.
The initial sample size was determined based on the expectation of 30% improvement of the primary outcome (BPD/death) in the intervention group (Curosurf + budesonide) (40%), as compared to control group (Curosurf +saline placebo) (60%), specifying a type I error of 0.05 and type II error 0.20. The total number needed was 240 (120 in each group). The study was started in June 2019 before the pandemic of COVID19 and the study went on smoothly in 2019. Because of the smooth enrollment of the patients in 2019, we decided to increase the ability of the study for detecting the intervention effect through increasing the power from 80 % to 90 % (type II error from 0.2 to 0.1 and type I error decreased from 0.05 to 0.02). The total sample size required was estimated to be 350 (170 in each group). Given the COVID19 pandemics, the recruitment became difficult. Under the consideration of scientific and practical consideration, we therefore determine to have a sample of 300, (150 in each group), fulfill the criteria of type I error 0.05, type II error 0.10, power 90% and with an expectation of 30 % improvement of primary outcome (from 60 % in control group to 40 % in the intervention group as original presumed). The changes in sample size had been approved by independent monitoring committee. We expect that the study will be completed in September 2022.
The sample will be stratified based on birth weight (500-749 grams, 750-999 grams and 1000-1499 grams), the presence of clinical chorioamnionitis or not, and site of study.
- Being tested
- budesonide, Saline
- Keywords
- BPD, surfactant, budesonide, respiratory distress syndrome
- Medical subject headings
- Respiratory Distress Syndrome, Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
budesonideDrug
Also called pulmicort
Intra-tracheal instillation of a combination of budesonide/surfactant in preterm infants with RDS to prevent BPD
SalineDrug
Also called sodium chloride
Intra-tracheal instillation of a combination of saline/surfactant in preterm infants with RDS to prevent BPD
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Active comparator | Curosurf + budesonide Receives: Drug: budesonide |
| Placebo | Placebo comparator | Curosurf + saline Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of death or BPD
Primary outcome of study is death or BPD defined by NICHD criteria.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start1 Jul 2019
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Taipei Medical 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a double blind randomized trial. The infants will be randomly assigned into 2 groups: Control (C) (curosurf + saline) and Intervention (I) (curosurf+ budesonide).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Medical University Hospital, National Taiwan University Hospital, Taipei Veterans General Hospital, Taiwan, Mackay Memorial Hospital, Chang Gung Memorial Hospital, China Medical University Hospital, Seventh Medical Center of PLA General Hospital, Guangzhou Women and Children's Medical Center, Taichung Veterans General Hospital
- Responsible party
- Sponsor
- Investigators
- Tsu F Yeh, M.D., Ph.D., Principal investigator, Maternal Child Health Research Center, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03275415
- Sponsor's protocol ID
- N201705026
- Status last verified
- Jun 2022
- First submitted
- 5 Sep 2017
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yeh 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 26351971Yeh 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 18426851Kuo HT, Lin HC, Tsai CH, Chouc IC, Yeh TF. A follow-up study of preterm infants given budesonide using surfactant as a vehicle to prevent chronic lung disease in preterm infants. J Pediatr. 2010 Apr;156(4):537-41. doi: 10.1016/j.jpeds.2009.10.049. Epub 2010 Feb 6.
PubMed 20138301
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Administration of Surfactant/Budesonide to Prevent BPD in VLBW With RDS-A Double Blind Study
- ClinicalTrials.gov ID
- NCT03275415
- Acronym / sponsor ID
- N201705026
- Keywords
- BPD, surfactant, budesonide, respiratory distress syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Collaborators
- Taipei Medical University Hospital, National Taiwan University Hospital, Taipei Veterans General Hospital, Taiwan, Mackay Memorial Hospital, Chang Gung Memorial Hospital, China Medical University Hospital, Seventh Medical Center of PLA General Hospital, Guangzhou Women and Children's Medical Center, Taichung Veterans General Hospital
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 7 Sep 2017 (actual)
- 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 double-blind study includes: 1) birth Wt 500-1499 gm, 2) respiratory distress shortly after birth and requires resuscitation 3) failure to NCPAP within 4 hrs after birth, defined as: a) FIO2 ≥ 0.30, pressure > 5cmH2O b) severe retraction c) apnea d) PCO2 ≥ 60 mmHg. Exclusion criteria: 1) lethal cardiopulmonary status 2) severe congenital anomalies.
Given the COVID19 pandemics, the recruitment became difficult. Under the consideration of scientific and practical consideration, we therefore determine to have a sample of 300, (150 in each group), fulfill the criteria of type I error 0.05, type II error 0.10, power 90% and with an expectation of 30 % improvement of primary outcome (from 60 % in control group to 40 % in the intervention group as original presumed).Appropriate amount of placebo will be used as it does not affect the biophysical property of curosurf (PAS abstract 2017 San Francisco). Primary outcome of study is death or BPD defined by NICHD criteria. Follow up study of neuromotor and cognitive function and pulmonary states will be done at 1-2 years of corrected age.
Detailed description
A double-blind study will be conducted in 7 tertiary centers. Inclusion criteria are: 1) birth Wt 500-1499 gm, 2) respiratory distress shortly after birth and requires resuscitation 3) failure to NCPAP within 4 hrs after birth, defined as: a) FIO2 ≥ 0.30, pressure > 5cmH2O b) severe retraction c) apnea d) PCO2 ≥ 60 mmHg. Exclusion criteria: 1) lethal cardiopulmonary status 2) severe congenital anomalies.
The initial sample size was determined based on the expectation of 30% improvement of the primary outcome (BPD/death) in the intervention group (Curosurf + budesonide) (40%), as compared to control group (Curosurf +saline placebo) (60%), specifying a type I error of 0.05 and type II error 0.20. The total number needed was 240 (120 in each group). The study was started in June 2019 before the pandemic of COVID19 and the study went on smoothly in 2019. Because of the smooth enrollment of the patients in 2019, we decided to increase the ability of the study for detecting the intervention effect through increasing the power from 80 % to 90 % (type II error from 0.2 to 0.1 and type I error decreased from 0.05 to 0.02). The total sample size required was estimated to be 350 (170 in each group). Given the COVID19 pandemics, the recruitment became difficult. Under the consideration of scientific and practical consideration, we therefore determine to have a sample of 300, (150 in each group), fulfill the criteria of type I error 0.05, type II error 0.10, power 90% and with an expectation of 30 % improvement of primary outcome (from 60 % in control group to 40 % in the intervention group as original presumed). The changes in sample size had been approved by independent monitoring committee. We expect that the study will be completed in September 2022.
The sample will be stratified based on birth weight (500-749 grams, 750-999 grams and 1000-1499 grams), the presence of clinical chorioamnionitis or not, and site of study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is a double blind randomized trial. The infants will be randomly assigned into 2 groups: Control (C) (curosurf + saline) and Intervention (I) (curosurf+ budesonide).
| Arm | Type | Receives |
|---|---|---|
| Experimental | Active comparator | Drug: budesonideCurosurf + budesonide |
| Placebo | Placebo comparator | Drug: SalineCurosurf + saline |
Who may qualify
- Ages
- 30 minutes to 4 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1) birth Wt 500-1499 gm, 2) respiratory distress shortly after birth and requires resuscitation, 3) failure to NCPAP within 4 hrs after birth, defined as: a) FIO2 ≥ 0.30, pressure > 5 cmH2O b) severe retraction c) apnea d) PCO2 ≥ 60 mmHg.
Key exclusion criteria (1 listed)
- 1) lethal cardiopulmonary status, 2) severe congenital anomalies.
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: pulmicortIntra-tracheal instillation of a combination of budesonide/surfactant in preterm infants with RDS to prevent BPD | Drug | Experimental |
| SalineAlso: sodium chlorideIntra-tracheal instillation of a combination of saline/surfactant in preterm infants with RDS to prevent BPD | Drug | Placebo |
Primary outcome
incidence of death or BPD
Time frame: 6 months
Primary outcome of study is death or BPD defined by NICHD criteria.
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 30 May 2023.
- Results publication: 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.
- Results publication: 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.
- Results publication: PubMed 20138301Kuo HT, Lin HC, Tsai CH, Chouc IC, Yeh TF. A follow-up study of preterm infants given budesonide using surfactant as a vehicle to prevent chronic lung disease in preterm infants. J Pediatr. 2010 Apr;156(4):537-41. doi: 10.1016/j.jpeds.2009.10.049. Epub 2010 Feb 6.
- Individual participant dataSharing planned: No
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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., Ph.D. principal investigator
Maternal Child Health Research Center, Taipei Medical University
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 and Saline in people with Respiratory Distress Syndrome and Bronchopulmonary Dysplasia, run by Taipei Medical University at 1 site in Taiwan.
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 1 inclusion and 1 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 30 May 2023. 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 Taiwan. 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?
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?
incidence of death or BPD (time frame: 6 months). 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 NCT03275415, which also lists 3 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 30 May 2023.