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

Primary Purpose

Bronchopulmonary Dysplasia, Infant,Premature, Respiratory Distress Syndrome

Status

Unknown status

Phase

Phase 4

Locations

Mexico

Study Type

Interventional

Intervention

Budesonide

Poractant Alfa

Saline

About this trial

This is an interventional prevention trial for Bronchopulmonary Dysplasia focused on measuring bronchopulmonary dysplasia, respiratory distress syndrome, budesonide, poractant alfa

Eligibility Criteria

undefined - 12 Hours (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hospital Central Dr. Ignacio Morones PrietoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Poractant alfa/budesonide

Poractant alfa/saline

Arm Description

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

A mixture of poractant (200mg/kg) and saline (1 ml/kg) will be instilled intratracheal

Outcomes

Primary Outcome Measures

Bronchopulmonary dysplasia or death

Diagnosis of bronchopulmonary dysplasia according to NICHD criteria

Secondary Outcome Measures

Full Information

NCT ID

NCT03521063

First Posted

April 28, 2018

Last Updated

August 6, 2019

Sponsor

Hospital Central "Dr. Ignacio Morones Prieto"

Collaborators

Universidad Autonoma de San Luis Potosí

1. Study Identification

Unique Protocol Identification Number

NCT03521063

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.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2018 (Actual)

Primary Completion Date

October 30, 2019 (Anticipated)

Study Completion Date

December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Central "Dr. Ignacio Morones Prieto"

Collaborators

Universidad Autonoma de San Luis Potosí

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bronchopulmonary Dysplasia, Infant,Premature, Respiratory Distress Syndrome

Keywords

bronchopulmonary dysplasia, respiratory distress syndrome, budesonide, poractant alfa

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Poractant alfa/budesonide

Arm Type

Experimental

Arm Description

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

Arm Title

Poractant alfa/saline

Arm Type

Active Comparator

Arm Description

A mixture of poractant (200mg/kg) and saline (1 ml/kg) will be instilled intratracheal

Intervention Type

Drug

Intervention Name(s)

Budesonide

Other Intervention Name(s)

Pulmicort

Intervention Description

Drug: Budesonide inhalation suspension

Intervention Type

Drug

Intervention Name(s)

Poractant Alfa

Other Intervention Name(s)

Curosurf

Intervention Description

Drug: Poractant alfa intratracheal suspension

Intervention Type

Drug

Intervention Name(s)

Saline

Other Intervention Name(s)

Normal saline

Intervention Description

Sodium chloride injection 0.9%

Primary Outcome Measure Information:

Title

Bronchopulmonary dysplasia or death

Description

Diagnosis of bronchopulmonary dysplasia according to NICHD criteria

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

10. Eligibility

Sex

All

Maximum Age & Unit of Time

12 Hours

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

RAUL H ROQUE SANCHEZ, MD

Phone

+524448342701

Ext

1522

raul_roque@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

FRANCISCO J ESCALANTE PADRON, MD

Phone

+524448342746

fcoescalantep@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

RAUL H ROQUE SANCHEZ, MD

Organizational Affiliation

Hospital Central "Dr. Ignacio Morones Prieto"

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Central Dr. Ignacio Morones Prieto

City

San Luis Potosí

ZIP/Postal Code

78290

Country

Mexico

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

RAUL H ROQUE SANCHEZ, MD

Phone

+524448342701

Ext

1522

raul_roque@yahoo.com

First Name & Middle Initial & Last Name & Degree

FRANCISCO J ESCALANTE PADRON, MD, MSC

Phone

+524448342746

fcoescalantep@yahoo.com

First Name & Middle Initial & Last Name & Degree

RAUL H ROQUE SANCHEZ, MD

First Name & Middle Initial & Last Name & Degree

FRANCISCO J ESCALANTE PADRON, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

11401896

Citation

Jobe AH, Bancalari E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med. 2001 Jun;163(7):1723-9. doi: 10.1164/ajrccm.163.7.2011060. No abstract available.

Results Reference

background

PubMed Identifier

23736015

Citation

Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Plavka R, Saugstad OD, Simeoni U, Speer CP, Vento M, Halliday HL; European Association of Perinatal Medicine. European consensus guidelines on the management of neonatal respiratory distress syndrome in preterm infants--2013 update. Neonatology. 2013;103(4):353-68. doi: 10.1159/000349928. Epub 2013 May 31.

Results Reference

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PubMed Identifier

26690260

Citation

Singh N, Halliday HL, Stevens TP, Suresh G, Soll R, Rojas-Reyes MX. Comparison of animal-derived surfactants for the prevention and treatment of respiratory distress syndrome in preterm infants. Cochrane Database Syst Rev. 2015 Dec 21;2015(12):CD010249. doi: 10.1002/14651858.CD010249.pub2.

Results Reference

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PubMed Identifier

26351971

Citation

Yeh TF, Chen CM, Wu SY, Husan Z, Li TC, Hsieh WS, Tsai CH, Lin HC. Intratracheal Administration of Budesonide/Surfactant to Prevent Bronchopulmonary Dysplasia. Am J Respir Crit Care Med. 2016 Jan 1;193(1):86-95. doi: 10.1164/rccm.201505-0861OC.

Results Reference

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PubMed Identifier

28165675

Citation

Venkataraman R, Kamaluddeen M, Hasan SU, Robertson HL, Lodha A. Intratracheal Administration of Budesonide-Surfactant in Prevention of Bronchopulmonary Dysplasia in Very Low Birth Weight Infants: A Systematic Review and Meta-Analysis. Pediatr Pulmonol. 2017 Jul;52(7):968-975. doi: 10.1002/ppul.23680. Epub 2017 Feb 6.

Results Reference

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

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