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

Hospital Central "Dr. Ignacio Morones Prieto"

Status and phase: Unknown; Phase 4

Conditions: Respiratory Distress Syndrome; Infant,Premature; Bronchopulmonary Dysplasia

Treatments: Drug: Poractant Alfa; Drug: Saline; Drug: Budesonide

Study type: Interventional

Funder types: Other

Identifiers

NCT03521063

86-17

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 estimated patients

Sex: All

Ages: Under 12 hours old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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108 participants in 2 patient groups

Poractant alfa/budesonide

Experimental group

Description:

A mixture of poractant (200mg/kg) and budesonide (0.25 mg/kg) will be instilled intratracheal

Treatment:

Drug: Budesonide

Drug: Poractant Alfa

Poractant alfa/saline

Active Comparator group

Description:

A mixture of poractant (200mg/kg) and saline (1 ml/kg) will be instilled intratracheal

Treatment:

Drug: Saline

Drug: Poractant Alfa