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

NCT03521063 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: 86-17
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchopulmonary Dysplasia; Infant,Premature; Respiratory Distress Syndrome

Keywords

bronchopulmonary dysplasia; respiratory distress syndrome; budesonide; poractant alfa

Outcome Measures

Primary Outcomes (1)

• Bronchopulmonary dysplasia or death

  Diagnosis of bronchopulmonary dysplasia according to NICHD criteria

  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

Study Arms (2)

Poractant alfa/budesonide

EXPERIMENTAL

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

Drug: Budesonide; Drug: Poractant Alfa

Poractant alfa/saline

ACTIVE COMPARATOR

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

Drug: Poractant Alfa; Drug: Saline

Interventions

Budesonide DRUG

Drug: Budesonide inhalation suspension

Also known as: Pulmicort

Poractant alfa/budesonide

Poractant Alfa DRUG

Drug: Poractant alfa intratracheal suspension

Also known as: Curosurf

Poractant alfa/budesonide; Poractant alfa/saline

Saline DRUG

Sodium chloride injection 0.9%

Also known as: Normal saline

Poractant alfa/saline

Eligibility Criteria

• Age: Up to 12 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Birth weight \<1500g
• Gestational age ≥ 26 weeks
• Respiratory distress syndrome that requires exogenous surfactant at birth or in the first 12 hours of life.

You may not qualify if:

• Major congenital anomalies.
• Perinatal asphyxia
• Respiratory depression secondary to general anesthesia.

Sponsors & Collaborators

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

Study Sites (1)

Hospital Central Dr. Ignacio Morones Prieto

San Luis Potosí City, 78290, Mexico

RECRUITING

Related Publications (5)

• 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.

  PMID: 11401896 BACKGROUND

• 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.

  PMID: 23736015 BACKGROUND

• 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.

  PMID: 26690260 BACKGROUND

• 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.

  PMID: 26351971 BACKGROUND

• 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.

  PMID: 28165675 BACKGROUND

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Premature Birth; Respiratory Distress Syndrome

Interventions

Budesonide; poractant alfa; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• RAUL H ROQUE SANCHEZ, MD

  Hospital Central "Dr. Ignacio Morones Prieto"

  PRINCIPAL INVESTIGATOR

Central Study Contacts

RAUL H ROQUE SANCHEZ, MD

CONTACT

+524448342701; raul_roque@yahoo.com

FRANCISCO J ESCALANTE PADRON, MD

CONTACT

+524448342746; fcoescalantep@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 28, 2018
• First Posted: May 11, 2018
• Study Start: January 1, 2018
• Primary Completion: October 30, 2019
• Study Completion: December 31, 2019
• Last Updated: August 7, 2019

Record last verified: 2019-08

Locations

ME (1)