Brief Title
Efficacy of Adding Budesonide to Poractant Alfa to Prevent Bronchopulmonary Dysplasia.
Official Title
Efficacy of Adding Budesonide to Poractant Alfa to Prevent Bronchopulmonary Dysplasia in Preterm Infants With Respiratory Distress Syndrome.
Brief 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.
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 Phase
Phase 4
Study Type
Interventional
Primary Outcome
Bronchopulmonary dysplasia or death
Condition
Bronchopulmonary Dysplasia
Intervention
Budesonide
Study Arms / Comparison Groups
Poractant alfa/budesonide
Description: A mixture of poractant (200mg/kg) and budesonide (0.25 mg/kg) will be instilled intratracheal
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
108
Start Date
January 1, 2018
Completion Date
December 31, 2019
Primary Completion Date
October 30, 2019
Eligibility Criteria
Inclusion Criteria: - Birth weight <1500g - Gestational age ≥ 26 weeks - Respiratory distress syndrome that requires exogenous surfactant at birth or in the first 12 hours of life. Exclusion Criteria: - Major congenital anomalies. - Perinatal asphyxia - Respiratory depression secondary to general anesthesia.
Gender
All
Ages
N/A - 12 Hours
Accepts Healthy Volunteers
No
Contacts
RAUL H ROQUE SANCHEZ, MD, +524448342701, [email protected]
Location Countries
Mexico
Location Countries
Mexico
Administrative Informations
NCT ID
NCT03521063
Organization ID
86-17
Responsible Party
Principal Investigator
Study Sponsor
Hospital Central "Dr. Ignacio Morones Prieto"
Collaborators
Universidad Autonoma de San Luis Potosí
Study Sponsor
RAUL H ROQUE SANCHEZ, MD, Principal Investigator, Hospital Central "Dr. Ignacio Morones Prieto"
Verification Date
August 2019