Skip to content

Efficacy of Adding Budesonide to Poractant Alfa to Prevent Bronchopulmonary Dysplasia.

Efficacy of Adding Budesonide to Poractant Alfa to Prevent Bronchopulmonary Dysplasia in Preterm Infants With Respiratory Distress Syndrome.

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03521063
Enrollment
108
Registered
2018-05-11
Start date
2018-01-01
Completion date
2019-12-31
Last updated
2019-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchopulmonary Dysplasia, Infant,Premature, Respiratory Distress Syndrome

Keywords

bronchopulmonary dysplasia, respiratory distress syndrome, budesonide, poractant alfa

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.

Interventions

DRUGBudesonide

Drug: Budesonide inhalation suspension

Drug: Poractant alfa intratracheal suspension

DRUGSaline

Sodium chloride injection 0.9%

Sponsors

Universidad Autonoma de San Luis Potosí
CollaboratorOTHER
Hospital Central Dr. Ignacio Morones Prieto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
No minimum to 12 Hours
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Bronchopulmonary dysplasia or deathOxygen requirement at 36 weeks post menstrual age in patients <32 weeks. Oxygen requirement between 29 to 55 days of age in patients >32 weeksDiagnosis of bronchopulmonary dysplasia according to NICHD criteria

Countries

Mexico

Contacts

Primary ContactRAUL H ROQUE SANCHEZ, MD
raul_roque@yahoo.com+524448342701
Backup ContactFRANCISCO J ESCALANTE PADRON, MD
fcoescalantep@yahoo.com+524448342746

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026