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

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ClinicalTrials.gov Identifier: NCT03521063
Recruitment Status : Recruiting
First Posted : May 10, 2018
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
Universidad Autonoma de San Luis Potosí
Information provided by (Responsible Party):
Raúl Héctor Roque Sánchez, Hospital Central "Dr. Ignacio Morones Prieto"

Tracking Information
First Submitted Date  ICMJE April 28, 2018
First Posted Date  ICMJE May 10, 2018
Last Update Posted Date August 7, 2019
Actual Study Start Date  ICMJE January 1, 2018
Estimated Primary Completion Date October 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03521063 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Adding Budesonide to Poractant Alfa to Prevent Bronchopulmonary Dysplasia.
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Bronchopulmonary Dysplasia
  • Infant,Premature
  • Respiratory Distress Syndrome
Intervention  ICMJE
  • Drug: Budesonide
    Drug: Budesonide inhalation suspension
    Other Name: Pulmicort
  • Drug: Poractant Alfa
    Drug: Poractant alfa intratracheal suspension
    Other Name: Curosurf
  • Drug: Saline
    Sodium chloride injection 0.9%
    Other Name: Normal saline
Study Arms  ICMJE
  • Experimental: Poractant alfa/budesonide
    A mixture of poractant (200mg/kg) and budesonide (0.25 mg/kg) will be instilled intratracheal
    Interventions:
    • Drug: Budesonide
    • Drug: Poractant Alfa
  • Active Comparator: Poractant alfa/saline
    A mixture of poractant (200mg/kg) and saline (1 ml/kg) will be instilled intratracheal
    Interventions:
    • Drug: Poractant Alfa
    • Drug: Saline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 28, 2018)
108
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date October 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 12 Hours   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: RAUL H ROQUE SANCHEZ, MD +524448342701 ext 1522 raul_roque@yahoo.com
Contact: FRANCISCO J ESCALANTE PADRON, MD +524448342746 fcoescalantep@yahoo.com
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03521063
Other Study ID Numbers  ICMJE 86-17
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Raúl Héctor Roque Sánchez, Hospital Central "Dr. Ignacio Morones Prieto"
Study Sponsor  ICMJE Hospital Central "Dr. Ignacio Morones Prieto"
Collaborators  ICMJE Universidad Autonoma de San Luis Potosí
Investigators  ICMJE
Principal Investigator: RAUL H ROQUE SANCHEZ, MD Hospital Central "Dr. Ignacio Morones Prieto"
PRS Account Hospital Central "Dr. Ignacio Morones Prieto"
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP