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

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Brief Title

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

Official Title

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

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 Phase

Phase 4

Study Type

Interventional

Primary Outcome

Bronchopulmonary dysplasia or death

Condition

Bronchopulmonary Dysplasia

Intervention

Budesonide

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

108

Start Date

January 1, 2018

Completion Date

December 31, 2019

Primary Completion Date

October 30, 2019

Eligibility Criteria

        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.

Gender

All

Ages

N/A - 12 Hours

Accepts Healthy Volunteers

No

Contacts

RAUL H ROQUE SANCHEZ, MD, +524448342701, [email protected]

Location Countries

Mexico

Location Countries

Mexico

Administrative Informations

NCT ID

NCT03521063

Organization ID

86-17

Responsible Party

Principal Investigator

Study Sponsor

Hospital Central "Dr. Ignacio Morones Prieto"

Collaborators

 Universidad Autonoma de San Luis Potosí

Study Sponsor

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

Verification Date

August 2019