Bronchopulmonary DysplasiaPhase 4NCT03521063
Efficacy of Adding Budesonide to Poractant Alfa to Prevent Bronchopulmonary Dysplasia.
A Phase 4 study testing Budesonide, Poractant Alfa and Saline in people with Bronchopulmonary Dysplasia and Infant,Premature, run by Hospital Central "Dr. Ignacio Morones Prieto" at 1 site in Mexico.
Trial summary
This study evaluates the addition of budesonide to poractant alfa to prevent bronchopulmonary dysplasia in preterm infants with respiratory distress syndrome. Half of the participants will receive budesonide and poractant alfa in combination, and the other half will receive poractant alfa with saline. Read more about this study
- Who is it for?
- Ages Up to 12 hours
- Conditions the study is for
- Bronchopulmonary Dysplasia, Infant,Premature, Respiratory Distress Syndrome
- What is being tested?
- Budesonide, Poractant Alfa and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jan 2018to 31 Dec 2019
- 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 Up to 12 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birth weight <1500g
- Gestational age ≥ 26 weeks
- Respiratory distress syndrome that requires exogenous surfactant at birth or in the first 12 hours of life.
Who cannot join
- Major congenital anomalies.
- Perinatal asphyxia
- Respiratory depression secondary to general anesthesia.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Hospital Central Dr. Ignacio Morones Prieto
San Luis Potosí City, 78290
RAUL H ROQUE SANCHEZ, MD, +524448342701 ext. 1522, raul_roque@yahoo.com
FRANCISCO J ESCALANTE PADRON, MD, MSC, +524448342746, fcoescalantep@yahoo.com
About this study
Official title: Efficacy of Adding Budesonide to Poractant Alfa to Prevent Bronchopulmonary Dysplasia in Preterm Infants With Respiratory Distress Syndrome.
This study evaluates the addition of budesonide to poractant alfa to prevent bronchopulmonary dysplasia in preterm infants with respiratory distress syndrome. Half of the participants will receive budesonide and poractant alfa in combination, and the other half will receive poractant alfa with saline.
Read the detailed description
A randomized double bind controlled trial, designed to evaluate the addition of budesonide to poractant alfa to prevent bronchopulmonary dysplasia (BPD) in preterm infants with respiratory distress syndrome (RDS).
The usual treatment of RDS includes ventilatory support and exogenous surfactant, however, a cronic lung disease known as BPD, is a complication found in many of these patients.
BPD is a complex disease occurring in preterm infants recovering from RDS and inflammation plays a key role in its physiopathology.
Animal derived surfactants have demonstrated to decrease the incidence of BPD, and porcine surfactant (poractant alfa) has and increased effect compared with bovine surfactant (beractant).
Budesonide is an inhaled anti-inflammatory steroid that has shown to reduce BPD when combined with beractant by decreasing lung inflammation, without secondary systemic effects, when combined with poractant alfa it could enhance even more this anti-inflammatory effect.
- Being tested
- Budesonide, Poractant Alfa, Saline
- Keywords
- bronchopulmonary dysplasia, respiratory distress syndrome, budesonide, poractant alfa
- Medical subject headings
- Bronchopulmonary Dysplasia, Premature Birth, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BudesonideDrug
Also called Pulmicort
Drug: Budesonide inhalation suspension
Poractant AlfaDrug
Also called Curosurf
Drug: Poractant alfa intratracheal suspension
SalineDrug
Also called Normal saline
Sodium chloride injection 0.9%
| Study group | Role | What they receive |
|---|---|---|
| Poractant alfa/budesonide | Experimental | A mixture of poractant (200mg/kg) and budesonide (0.25 mg/kg) will be instilled intratracheal Receives: Drug: Budesonide; Drug: Poractant Alfa |
| Poractant alfa/saline | Active comparator | A mixture of poractant (200mg/kg) and saline (1 ml/kg) will be instilled intratracheal Receives: Drug: Poractant Alfa; Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bronchopulmonary dysplasia or death
Diagnosis of bronchopulmonary dysplasia according to NICHD criteria
Measured: Oxygen requirement at 36 weeks post menstrual age in patients <32 weeks. Oxygen requirement between 29 to 55 days of age in patients >32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start1 Jan 2018
- Primary completion30 Oct 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Central "Dr. Ignacio Morones Prieto"
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Autonoma de San Luis Potosí
- Responsible party
- Principal investigator, Raúl Héctor Roque Sánchez, Hospital Central "Dr. Ignacio Morones Prieto"
- Investigators
- RAUL H ROQUE SANCHEZ, MD, Principal investigator, Hospital Central "Dr. Ignacio Morones Prieto"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03521063
- Sponsor's protocol ID
- 86-17
- Status last verified
- Aug 2019
- First submitted
- 28 Apr 2018
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jobe AH, Bancalari E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med. 2001 Jun;163(7):1723-9. doi: 10.1164/ajrccm.163.7.2011060. No abstract available.
PubMed 11401896Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Plavka R, Saugstad OD, Simeoni U, Speer CP, Vento M, Halliday HL; European Association of Perinatal Medicine. European consensus guidelines on the management of neonatal respiratory distress syndrome in preterm infants--2013 update. Neonatology. 2013;103(4):353-68. doi: 10.1159/000349928. Epub 2013 May 31.
PubMed 23736015Singh N, Halliday HL, Stevens TP, Suresh G, Soll R, Rojas-Reyes MX. Comparison of animal-derived surfactants for the prevention and treatment of respiratory distress syndrome in preterm infants. Cochrane Database Syst Rev. 2015 Dec 21;2015(12):CD010249. doi: 10.1002/14651858.CD010249.pub2.
PubMed 26690260Yeh 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 26351971Venkataraman R, Kamaluddeen M, Hasan SU, Robertson HL, Lodha A. Intratracheal Administration of Budesonide-Surfactant in Prevention of Bronchopulmonary Dysplasia in Very Low Birth Weight Infants: A Systematic Review and Meta-Analysis. Pediatr Pulmonol. 2017 Jul;52(7):968-975. doi: 10.1002/ppul.23680. Epub 2017 Feb 6.
PubMed 28165675
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Adding Budesonide to Poractant Alfa to Prevent Bronchopulmonary Dysplasia in Preterm Infants With Respiratory Distress Syndrome.
- ClinicalTrials.gov ID
- NCT03521063
- Acronym / sponsor ID
- 86-17
- Keywords
- bronchopulmonary dysplasia, respiratory distress syndrome, budesonide, poractant alfa
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Hospital Central "Dr. Ignacio Morones Prieto"University, hospital or other
- Collaborators
- Universidad Autonoma de San Luis Potosí
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Oct 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 11 May 2018 (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.
This study evaluates the addition of budesonide to poractant alfa to prevent bronchopulmonary dysplasia in preterm infants with respiratory distress syndrome. Half of the participants will receive budesonide and poractant alfa in combination, and the other half will receive poractant alfa with saline.
Detailed description
A randomized double bind controlled trial, designed to evaluate the addition of budesonide to poractant alfa to prevent bronchopulmonary dysplasia (BPD) in preterm infants with respiratory distress syndrome (RDS).
The usual treatment of RDS includes ventilatory support and exogenous surfactant, however, a cronic lung disease known as BPD, is a complication found in many of these patients.
BPD is a complex disease occurring in preterm infants recovering from RDS and inflammation plays a key role in its physiopathology.
Animal derived surfactants have demonstrated to decrease the incidence of BPD, and porcine surfactant (poractant alfa) has and increased effect compared with bovine surfactant (beractant).
Budesonide is an inhaled anti-inflammatory steroid that has shown to reduce BPD when combined with beractant by decreasing lung inflammation, without secondary systemic effects, when combined with poractant alfa it could enhance even more this anti-inflammatory effect.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Poractant alfa/budesonide | Experimental | Drug: Budesonide, Drug: Poractant AlfaA mixture of poractant (200mg/kg) and budesonide (0.25 mg/kg) will be instilled intratracheal |
| Poractant alfa/saline | Active comparator | Drug: Poractant Alfa, Drug: SalineA mixture of poractant (200mg/kg) and saline (1 ml/kg) will be instilled intratracheal |
Who may qualify
- Ages
- Up to 12 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Birth weight <1500g
- Gestational age ≥ 26 weeks
- Respiratory distress syndrome that requires exogenous surfactant at birth or in the first 12 hours of life.
Key exclusion criteria (3 listed)
- Major congenital anomalies.
- Perinatal asphyxia
- Respiratory depression secondary to general anesthesia.
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: PulmicortDrug: Budesonide inhalation suspension | Drug | Poractant alfa/budesonide |
| Poractant AlfaAlso: CurosurfDrug: Poractant alfa intratracheal suspension | Drug | Poractant alfa/budesonide, Poractant alfa/saline |
| SalineAlso: Normal salineSodium chloride injection 0.9% | Drug | Poractant alfa/saline |
Primary outcome
Bronchopulmonary dysplasia or death
Time frame: Oxygen requirement at 36 weeks post menstrual age in patients <32 weeks. Oxygen requirement between 29 to 55 days of age in patients >32 weeks
Diagnosis of bronchopulmonary dysplasia according to NICHD criteria
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Background: PubMed 11401896Jobe AH, Bancalari E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med. 2001 Jun;163(7):1723-9. doi: 10.1164/ajrccm.163.7.2011060. No abstract available.
- Background: PubMed 23736015Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Plavka R, Saugstad OD, Simeoni U, Speer CP, Vento M, Halliday HL; European Association of Perinatal Medicine. European consensus guidelines on the management of neonatal respiratory distress syndrome in preterm infants--2013 update. Neonatology. 2013;103(4):353-68. doi: 10.1159/000349928. Epub 2013 May 31.
- Background: PubMed 26690260Singh N, Halliday HL, Stevens TP, Suresh G, Soll R, Rojas-Reyes MX. Comparison of animal-derived surfactants for the prevention and treatment of respiratory distress syndrome in preterm infants. Cochrane Database Syst Rev. 2015 Dec 21;2015(12):CD010249. doi: 10.1002/14651858.CD010249.pub2.
- Background: 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.
- Background: PubMed 28165675Venkataraman R, Kamaluddeen M, Hasan SU, Robertson HL, Lodha A. Intratracheal Administration of Budesonide-Surfactant in Prevention of Bronchopulmonary Dysplasia in Very Low Birth Weight Infants: A Systematic Review and Meta-Analysis. Pediatr Pulmonol. 2017 Jul;52(7):968-975. doi: 10.1002/ppul.23680. Epub 2017 Feb 6.
- Individual participant dataSharing planned: Undecided
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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.
RAUL H ROQUE SANCHEZ, MD principal investigator
Hospital Central "Dr. Ignacio Morones Prieto"
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, Poractant Alfa and Saline in people with Bronchopulmonary Dysplasia and Infant,Premature, run by Hospital Central "Dr. Ignacio Morones Prieto" at 1 site in Mexico.
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 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 7 Aug 2019. 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 Mexico. 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 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 RAUL H ROQUE SANCHEZ, MD (+524448342701 ext. 1522, raul_roque@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bronchopulmonary dysplasia or death (time frame: Oxygen requirement at 36 weeks post menstrual age in patients <32 weeks. Oxygen requirement between 29 to 55 days of age in patients >32 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 NCT03521063, which also lists 5 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 7 Aug 2019.