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

H

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

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

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

Trial contacts and locations

1

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Central trial contact

RAUL H ROQUE SANCHEZ, MD; FRANCISCO J ESCALANTE PADRON, MD

Data sourced from clinicaltrials.gov

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