Trials / Unknown
UnknownNCT03521063
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
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 108 (estimated)
- Sponsor
- Hospital Central "Dr. Ignacio Morones Prieto" · Academic / Other
- Sex
- All
- Age
- 12 Hours
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Budesonide | Drug: Budesonide inhalation suspension |
| DRUG | Poractant Alfa | Drug: Poractant alfa intratracheal suspension |
| DRUG | Saline | Sodium chloride injection 0.9% |
Timeline
- Start date
- 2018-01-01
- Primary completion
- 2019-10-30
- Completion
- 2019-12-31
- First posted
- 2018-05-11
- Last updated
- 2019-08-07
Locations
1 site across 1 country: Mexico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03521063. Inclusion in this directory is not an endorsement.