Intratracheal Budesonide/Surfactant Prevents BPD

NCT03275415 | Completed Phase 4 DMC

• 1 other identifier: N201705026
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

Brief Summary

A double-blind study includes: 1) birth Wt 500-1499 gm, 2) respiratory distress shortly after birth and requires resuscitation 3) failure to NCPAP within 4 hrs after birth, defined as: a) FIO2 ≥ 0.30, pressure \> 5cmH2O b) severe retraction c) apnea d) PCO2 ≥ 60 mmHg. Exclusion criteria: 1) lethal cardiopulmonary status 2) severe congenital anomalies. Given the COVID19 pandemics, the recruitment became difficult. Under the consideration of scientific and practical consideration, we therefore determine to have a sample of 300, (150 in each group), fulfill the criteria of type I error 0.05, type II error 0.10, power 90% and with an expectation of 30 % improvement of primary outcome (from 60 % in control group to 40 % in the intervention group as original presumed).Appropriate amount of placebo will be used as it does not affect the biophysical property of curosurf (PAS abstract 2017 San Francisco). Primary outcome of study is death or BPD defined by NICHD criteria. Follow up study of neuromotor and cognitive function and pulmonary states will be done at 1-2 years of corrected age.

Conditions

Respiratory Distress Syndrome; Bronchopulmonary Dysplasia

Keywords

BPD; surfactant; budesonide; respiratory distress syndrome

Outcome Measures

Primary Outcomes (1)

• incidence of death or BPD

  Primary outcome of study is death or BPD defined by NICHD criteria.

  6 months

Study Arms (2)

Experimental

ACTIVE COMPARATOR

Curosurf + budesonide

Drug: budesonide

Placebo

PLACEBO COMPARATOR

Curosurf + saline

Drug: Saline

Interventions

budesonide DRUG

Intra-tracheal instillation of a combination of budesonide/surfactant in preterm infants with RDS to prevent BPD

Also known as: pulmicort

Experimental

Saline DRUG

Intra-tracheal instillation of a combination of saline/surfactant in preterm infants with RDS to prevent BPD

Also known as: sodium chloride

Placebo

Eligibility Criteria

• Age: 30 Minutes - 4 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \) birth Wt 500-1499 gm, 2) respiratory distress shortly after birth and requires resuscitation, 3) failure to NCPAP within 4 hrs after birth, defined as: a) FIO2 ≥ 0.30, pressure \> 5 cmH2O b) severe retraction c) apnea d) PCO2 ≥ 60 mmHg.

You may not qualify if:

• \) lethal cardiopulmonary status, 2) severe congenital anomalies.

Sponsors & Collaborators

• Taipei Medical University: lead
• Taipei Medical University Hospital: collaborator
• National Taiwan University Hospital: collaborator
• Taipei Veterans General Hospital, Taiwan: collaborator
• Mackay Memorial Hospital: collaborator
• Chang Gung Memorial Hospital: collaborator
• China Medical University Hospital: collaborator
• Seventh Medical Center of PLA General Hospital: collaborator
• Guangzhou Women and Children's Medical Center: collaborator
• Taichung Veterans General Hospital: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (3)

• 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 RESULT

• Yeh TF, Lin HC, Chang CH, Wu TS, Su BH, Li TC, Pyati S, Tsai CH. Early intratracheal instillation of budesonide using surfactant as a vehicle to prevent chronic lung disease in preterm infants: a pilot study. Pediatrics. 2008 May;121(5):e1310-8. doi: 10.1542/peds.2007-1973. Epub 2008 Apr 21.

  PMID: 18426851 RESULT

• Kuo HT, Lin HC, Tsai CH, Chouc IC, Yeh TF. A follow-up study of preterm infants given budesonide using surfactant as a vehicle to prevent chronic lung disease in preterm infants. J Pediatr. 2010 Apr;156(4):537-41. doi: 10.1016/j.jpeds.2009.10.049. Epub 2010 Feb 6.

  PMID: 20138301 RESULT

MeSH Terms

Conditions

Respiratory Distress Syndrome; Bronchopulmonary Dysplasia

Interventions

Budesonide; Sodium Chloride

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Ventilator-Induced Lung Injury; Lung Injury; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Tsu F Yeh, M.D., Ph.D.

  Maternal Child Health Research Center, Taipei Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This is a double blind randomized trial. The infants will be randomly assigned into 2 groups: Control (C) (curosurf + saline) and Intervention (I) (curosurf+ budesonide).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a double blind randomized trial. The infants will be randomly assigned into 2 groups: Control (C) (curosurf + saline) and Intervention (I) (curosurf+ budesonide).

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: September 7, 2017
• Study Start: July 1, 2019
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: May 30, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)