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

NCT03521063 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2019-08-07

No results posted yet for this study

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.

Conditions

  • Bronchopulmonary Dysplasia
  • Infant,Premature
  • Respiratory Distress Syndrome

Interventions

DRUG

Budesonide

Drug: Budesonide inhalation suspension

DRUG

Poractant Alfa

Drug: Poractant alfa intratracheal suspension

DRUG

Saline

Sodium chloride injection 0.9%

Sponsors & Collaborators

  • Universidad Autonoma de San Luis Potosí

    collaborator OTHER

  • Hospital Central "Dr. Ignacio Morones Prieto"

    lead OTHER

Principal Investigators

  • RAUL H ROQUE SANCHEZ, MD · Hospital Central "Dr. Ignacio Morones Prieto"

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
12 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2019-10-30
Completion
2019-12-31
FDA Drug
Yes

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03521063 on ClinicalTrials.gov