Budesonia + Intratracheal Surfactant in Incidence of Bronchopulmonary Dysplasia

NCT05534685 | Unknown

• 1 other identifier: Budesonia + surfactan
• Study Type: interventional
• Target: 336
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objectiv: To compare the effect of intratracheal administration of surfactant vs. surfactant/budesonide on the incidence of bronchopulmonary dysplasia in preterm infants less than 34 weeks of gestation. Material and methods: Study design: Double-blind randomized controlled clinical trial.Inclusion criteria: Newborns under 34 weeks of gestation with a diagnosis of Respiratory Distress Syndrome requiring administration of surfactant, invasive and/or non-invasive ventilatory support admitted to the Neonatal Intensive Care Unit service and pathological nursery. Procedure: 328 patients will be included from Group A: 164 patients, from Group B: 164 patients who meet the selection criteria within the first 4 hours of hospital stay, after the authorization of the parents or guardian signing the informed consent. According to the assigned group, the preparation of surfactant or surfactant/budesonide in the syringe will be carried out, prior to performing the tracheal cannulation procedure. Group A will be given surfactant (beractant, lung phospholipids of bovine origin. Injectable suspension 1ml contains 25mg) at a dose of 100mg/kg or 4ml/kg and budesonide (budesonide, nebulized suspension 2ml contains 0.500mg) at a dose of 0.250 mg/kg or 1 ml/kg. Group B will receive surfactant alone (beractant, lung phospholipids of bovine origin. Injectable suspension 1ml contains 25mg) administered at a dose of 100mg/kg or 4ml/kg. Subsequently, follow-up will be carried out at 12 hours to assess the administration of the second dose of surfactant, type of mechanical ventilation, inspired fraction of oxygen (Fi02), arterial pressure of oxygen (PaO2), partial pressure of carbon dioxide (PaCO2 ), mean airway pressure (PMVA), oxygen index (IO), oxygen saturation by pulse oximetry, weekly follow-up of the patient will continue for 28 days, evaluating the same parameters to make a diagnosis of bronchopulmonary dysplasia and finally at 36 postmenstrual weeks of gestation in those under 32 SDG or at discharge and at 56 postmenstrual days of life in those over 32 SDG or at discharge, allowing the severity of the disease to be determined.Sample size: The study includes an intervention group (surfactant/budesonide group) and a control group (surfactant only group), each with 164 patients, for a total of 328 patients. Statistical analysis: The Chi-Square statistician will be used with a precision requirement of 95%, where p\<=0.05. The risk measurement will be with RR (RR) and its 95% confidence interval (CI). NICSS 2007 statistical package will be used. Ethical aspects: This study must have an authorization signature through informed consent.

Conditions

Respiratory Tract Diseases

Keywords

Surfactant/Budesonide, Bronchopulmonary Dysplasia. Preterm

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-Related Adverse Events

  evaluate the adverse events that occur. Budesonide: headache, stomach pain, hyperglycemia, electrolyte disturbances. Surfactant: bradycardia, hypotension, endotracheal tube obstruction, desaturation, patent ductus arteriosus, pulmonary hemorrhage

  the fisrt 48 hours, util the week of extrauterine will be monitored

Secondary Outcomes (1)

• Assess the indicence of broncopulmonary displasia

  first 28 days of extrauterine life our 36 postmenstrual weeks of gestation

Study Arms (2)

intratracheal administration of surfactant/budesonide on the incidence of bronchopulmonary dysplasia

EXPERIMENTAL

Group A will be given surfactant (beractant, lung phospholipids of bovine origin. Injectable suspension 1ml contains 25mg) at a dose of 100mg/kg or 4ml/kg and budesonide (budesonide, nebulized suspension 2ml contains 0.500mg) at a dose of 0.250 mg/kg or 1 ml/kg.

Other: intratracheal administration of surfactant/budesonide

intratracheal administration of surfactant on the incidence of bronchopulmonary dysplasia

EXPERIMENTAL

Group B will receive surfactant alone (beractant, lung phospholipids of bovine origin. Injectable suspension 1ml contains 25mg) administered at a dose of 100mg/kg or 4ml/kg.

Other: incidence of bronchopulmonary dysplasia

Interventions

intratracheal administration of surfactant/budesonide OTHER

328 patients will be included from Group A: 164 patients, from Group B: 164 patients who meet the selection criteria within the first 4 hours of hospital stay, after the authorization of the parents or guardian signing the informed consent. According to the assigned group, the preparation of surfactant or surfactant/budesonide in the syringe will be carried out, prior to performing the tracheal cannulation procedure. Group A will be given surfactant (beractant, lung phospholipids of bovine origin. Injectable suspension 1ml contains 25mg) at a dose of 100mg/kg or 4ml/kg and budesonide (budesonide, nebulized suspension 2ml contains 0.500mg) at a dose of 0.250 mg/kg or 1 ml/kg. Group B will receive surfactant alone (beractant, lung phospholipids of bovine origin. Injectable suspension 1ml contains 25mg) administered at a dose of 100mg/kg or 4ml/kg.

Also known as: intratracheal administration of surfactant

intratracheal administration of surfactant/budesonide on the incidence of bronchopulmonary dysplasia

incidence of bronchopulmonary dysplasia OTHER

. Subsequently, follow-up will be carried out at 12 hours to assess the administration of the second dose of surfactant, type of mechanical ventilation, inspired fraction of oxygen (Fi02), arterial pressure of oxygen (PaO2), partial pressure of carbon dioxide (PaCO2 ), mean airway pressure (PMVA), oxygen index (IO), oxygen saturation by pulse oximetry, weekly follow-up of the patient will continue for 28 days, evaluating the same parameters to make a diagnosis of bronchopulmonary dysplasia and finally at 36 postmenstrual weeks of gestation in those under 32 SDG or at discharge and at 56 postmenstrual days of life in those over 32 SDG or at discharge, allowing the severity of the disease to be determined

intratracheal administration of surfactant on the incidence of bronchopulmonary dysplasia

Eligibility Criteria

• Age: 26 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Preterm newborn with clinical and radiographic data of respiratory distress syndrome requiring administration of surfactant.
• Newborn both sexes. Preterm newborn requiring invasive and/or non-invasive ventilatory support. Preterm infant who has and does not have antenatal exposure to steroids.

You may not qualify if:

• Elimination criteria: Patient whose parents withdraw their consent.

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead
• Instituto Mexicano del Seguro Social: collaborator

Related Publications (2)

• Tang W, Chen S, Shi D, Ai T, Zhang L, Huang Y, Fan Y, Du Y. Effectiveness and safety of early combined utilization of budesonide and surfactant by airway for bronchopulmonary dysplasia prevention in premature infants with RDS: A meta-analysis. Pediatr Pulmonol. 2022 Feb;57(2):455-469. doi: 10.1002/ppul.25759. Epub 2021 Nov 25.

  PMID: 34783192 RESULT

• Gharehbaghi MM, Mhallei M, Ganji S, Yasrebinia S. The efficacy of intratracheal administration of surfactant and budesonide combination in the prevention of bronchopulmonary dysplasia. J Res Med Sci. 2021 May 27;26:31. doi: 10.4103/jrms.JRMS_106_19. eCollection 2021.

  PMID: 34345242 RESULT

MeSH Terms

Conditions

Respiratory Tract Diseases

Interventions

Budesonide

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Guadalupe Gómez Rodríguez

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

• José Luis Felipe Luna Anguiano

  Instituto Mexicano del Seguro Social

  STUDY DIRECTOR

Central Study Contacts

Guadalupe Gómez Rodríguez

CONTACT

524778801400; lupitaneonato@gmail.com

Guadalupe Gómez Rodríguez

CONTACT

524777174800; lupitaneonato@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 9, 2022
• Study Start: September 20, 2022
• Primary Completion: February 20, 2023
• Study Completion: July 20, 2023
• Last Updated: September 14, 2022

Record last verified: 2022-09