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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"

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
Bronchopulmonary Dysplasia Infant,Premature Respiratory Distress Syndrome Drug: Budesonide Drug: Poractant Alfa Drug: Saline 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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 1, 2018
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : December 31, 2019


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 Name: Pulmicort

Drug: Poractant Alfa
Drug: Poractant alfa intratracheal suspension
Other Name: 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 Name: Curosurf

Drug: Saline
Sodium chloride injection 0.9%
Other Name: Normal saline




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   up to 12 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03521063


Contacts
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Contact: RAUL H ROQUE SANCHEZ, MD +524448342701 ext 1522 raul_roque@yahoo.com
Contact: FRANCISCO J ESCALANTE PADRON, MD +524448342746 fcoescalantep@yahoo.com

Locations
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Mexico
Hospital Central Dr. Ignacio Morones Prieto Recruiting
San Luis Potosí, Mexico, 78290
Contact: RAUL H ROQUE SANCHEZ, MD    +524448342701 ext 1522    raul_roque@yahoo.com   
Contact: FRANCISCO J ESCALANTE PADRON, MD, MSC    +524448342746    fcoescalantep@yahoo.com   
Principal Investigator: RAUL H ROQUE SANCHEZ, MD         
Sub-Investigator: FRANCISCO J ESCALANTE PADRON, MD         
Sponsors and Collaborators
Hospital Central "Dr. Ignacio Morones Prieto"
Universidad Autonoma de San Luis Potosí
Investigators
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Principal Investigator: RAUL H ROQUE SANCHEZ, MD Hospital Central "Dr. Ignacio Morones Prieto"

Publications:
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Responsible Party: Raúl Héctor Roque Sánchez, MD, Hospital Central "Dr. Ignacio Morones Prieto"
ClinicalTrials.gov Identifier: NCT03521063     History of Changes
Other Study ID Numbers: 86-17
First Posted: May 10, 2018    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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, Hospital Central "Dr. Ignacio Morones Prieto":
bronchopulmonary dysplasia
respiratory distress syndrome
budesonide
poractant alfa

Additional relevant MeSH terms:
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Syndrome
Hyperplasia
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Bronchopulmonary Dysplasia
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Ventilator-Induced Lung Injury
Lung Injury
Budesonide
Poractant alfa
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pulmonary Surfactants