Clinical trial NCT03521063: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bronchopulmonary Dysplasia
Infant,Premature
Respiratory Distress Syndrome
Keywords: bronchopulmonary dysplasia
respiratory distress syndrome
budesonide
poractant alfa
Lead sponsor: Hospital Central "Dr. Ignacio Morones Prieto"
Sponsor class: OTHER
Collaborators: name: Universidad Autonoma de San Luis Potosí
First posted: 2018-05-11
Enrollment: 108
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Bronchopulmonary dysplasia or death
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: San Luis Potosí
country: Mexico
facility: Hospital Central Dr. Ignacio Morones Prieto
Study officials:
affiliation: Hospital Central "Dr. Ignacio Morones Prieto"
name: RAUL H ROQUE SANCHEZ, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.