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

Phase 4

• Conditions: Infant,Premature; Respiratory Distress Syndrome; Bronchopulmonary Dysplasia
• Interventions: Drug: Budesonide; Drug: Saline; Drug: Poractant Alfa

• Registration Number: NCT03521063
• Lead Sponsor: Hospital Central "Dr. Ignacio Morones Prieto"

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 Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-04-28
• Study First Submitted QC: 2018-04-28
• Study First Posted: 2018-05-11
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-06
• Last Update Posted: 2019-08-07
• Primary Completion: 2019-10-30
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 108

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Poractant alfa/saline	Saline	A mixture of poractant (200mg/kg) and saline (1 ml/kg) will be instilled intratracheal
Poractant alfa/budesonide	Budesonide	A mixture of poractant (200mg/kg) and budesonide (0.25 mg/kg) will be instilled intratracheal
Poractant alfa/budesonide	Poractant Alfa	A mixture of poractant (200mg/kg) and budesonide (0.25 mg/kg) will be instilled intratracheal
Poractant alfa/saline	Poractant Alfa	A mixture of poractant (200mg/kg) and saline (1 ml/kg) will be instilled intratracheal

Primary Outcome Measures

Name	Time	Method
Bronchopulmonary dysplasia or death	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	Diagnosis of bronchopulmonary dysplasia according to NICHD criteria

Trial Locations

Locations (1)

Hospital Central Dr. Ignacio Morones Prieto; 🇲🇽 San Luis Potosí, Mexico