Efficacy of Adding Budesonide to Poractant Alfa to Prevent Bronchopulmonary Dysplasia.
NCT ID: NCT03521063
Last Updated: 2019-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
108 participants
INTERVENTIONAL
2018-01-01
2019-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Poractant alfa/budesonide
A mixture of poractant (200mg/kg) and budesonide (0.25 mg/kg) will be instilled intratracheal
Budesonide
Drug: Budesonide inhalation suspension
Poractant Alfa
Drug: Poractant alfa intratracheal suspension
Poractant alfa/saline
A mixture of poractant (200mg/kg) and saline (1 ml/kg) will be instilled intratracheal
Poractant Alfa
Drug: Poractant alfa intratracheal suspension
Saline
Sodium chloride injection 0.9%
Interventions
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Budesonide
Drug: Budesonide inhalation suspension
Poractant Alfa
Drug: Poractant alfa intratracheal suspension
Saline
Sodium chloride injection 0.9%
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Gestational age ≥ 26 weeks
* Respiratory distress syndrome that requires exogenous surfactant at birth or in the first 12 hours of life.
Exclusion Criteria
* Perinatal asphyxia
* Respiratory depression secondary to general anesthesia.
12 Hours
ALL
No
Sponsors
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Universidad Autonoma de San Luis Potosí
OTHER
Hospital Central "Dr. Ignacio Morones Prieto"
OTHER
Responsible Party
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Raúl Héctor Roque Sánchez
MD
Principal Investigators
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RAUL H ROQUE SANCHEZ, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Central "Dr. Ignacio Morones Prieto"
Locations
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Hospital Central Dr. Ignacio Morones Prieto
San Luis Potosí City, , Mexico
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Sweet 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.
Singh 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.
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.
Venkataraman 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.
Other Identifiers
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86-17
Identifier Type: -
Identifier Source: org_study_id
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