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

Sponsor
Hospital Central "Dr. Ignacio Morones Prieto" (Other)
Overall Status
Unknown status
CT.gov ID
NCT03521063
Collaborator
Universidad Autonoma de San Luis Potosí (Other)
108
Enrollment
1
Location
2
Arms
24
Anticipated Duration (Months)
4.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
108 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
Official Title:
Efficacy of Adding Budesonide to Poractant Alfa to Prevent Bronchopulmonary Dysplasia in Preterm Infants With Respiratory Distress Syndrome.
Actual Study Start Date :
Jan 1, 2018
Anticipated Primary Completion Date :
Oct 30, 2019
Anticipated Study Completion Date :
Dec 31, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Bronchopulmonary dysplasia or death [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 12 Hours
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Central Dr. Ignacio Morones Prieto San Luis Potosí Mexico 78290

    Sponsors and Collaborators

    • Hospital Central "Dr. Ignacio Morones Prieto"
    • Universidad Autonoma de San Luis Potosí

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Raúl Héctor Roque Sánchez, MD, Hospital Central "Dr. Ignacio Morones Prieto"
    ClinicalTrials.gov Identifier:
    NCT03521063
    Other Study ID Numbers:
    • 86-17
    First Posted:
    May 11, 2018
    Last Update Posted:
    Aug 7, 2019
    Last Verified:
    Aug 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Keywords provided by Raúl Héctor Roque Sánchez, MD, Hospital Central "Dr. Ignacio Morones Prieto"
    bronchopulmonary dysplasia
    respiratory distress syndrome
    budesonide
    poractant alfa
    Additional relevant MeSH terms:
    Respiratory Distress Syndrome
    Respiratory Distress Syndrome, Newborn
    Bronchopulmonary Dysplasia
    Syndrome
    Hyperplasia
    Budesonide
    Poractant alfa

    Study Results

    No Results Posted as of Aug 7, 2019