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

Study Overview
=================
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.

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

Conditions
-----------------
Bronchopulmonary Dysplasia, Infant,Premature, Respiratory Distress Syndrome

Intervention / Treatment
-----------------
* Drug: Budesonide
* Drug: Poractant Alfa
* Drug: Saline


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Maximum Age: 12 Hours

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Poractant alfa/budesonide<br>A mixture of poractant (200mg/kg) and budesonide (0.25 mg/kg) will be instilled intratracheal | Drug: Budesonide<br>* Drug: Budesonide inhalation suspension<br>* Other names: Pulmicort;Drug: Poractant Alfa<br>* Drug: Poractant alfa intratracheal suspension<br>* Other names: Curosurf;|
| Active Comparator: Poractant alfa/saline<br>A mixture of poractant (200mg/kg) and saline (1 ml/kg) will be instilled intratracheal | Drug: Poractant Alfa<br>* Drug: Poractant alfa intratracheal suspension<br>* Other names: Curosurf;Drug: Saline<br>* Sodium chloride injection 0.9%<br>* Other names: Normal saline;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bronchopulmonary dysplasia or death | Diagnosis of bronchopulmonary dysplasia according to NICHD criteria | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bronchopulmonary dysplasia, respiratory distress syndrome, budesonide, poractant alfa