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

August 6, 2019 updated by: Raúl Héctor Roque Sánchez, Hospital Central "Dr. Ignacio Morones Prieto"

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

108

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
      • San Luis Potosí, Mexico, 78290
        • Recruiting
        • Hospital Central Dr. Ignacio Morones Prieto
        • Contact:
        • Contact:
        • Principal Investigator:
          • RAUL H ROQUE SANCHEZ, MD
        • Sub-Investigator:
          • FRANCISCO J ESCALANTE PADRON, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 12 hours (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bronchopulmonary dysplasia or death
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Central "Dr. Ignacio Morones Prieto"

Collaborators

Universidad Autonoma de San Luis Potosí

Investigators

  • Principal Investigator: RAUL H ROQUE SANCHEZ, MD, Hospital Central "Dr. Ignacio Morones Prieto"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Anticipated)

October 30, 2019

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

April 28, 2018

First Submitted That Met QC Criteria

April 28, 2018

First Posted (Actual)

May 11, 2018

Study Record Updates

Last Update Posted (Actual)

August 7, 2019

Last Update Submitted That Met QC Criteria

August 6, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 86-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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