Intra-tracheal Instillation of Budesonide to Prevent Chronic Lung Disease (STOPCLD)

Intra-tracheal Instillation of Budesonide Along With Surfactant in Preterm Infants to Prevent Chronic Lung Disease

Preterm infants are randomized to received either Intra-tracheal instillation of budesonide using surfactant as vehicle or a placebo. Intra-tracheal instillation of budesonide using surfactant as vehicle would facilitate its delivery to the periphery of the lung and would inhibit lung inflammation and mitigate acute lung injury.

Study Overview

• Status: Recruiting
• Conditions: Acute Lung Injury; Chronic Lung Disease of Prematurity; Infant, Extremely Premature; Budesonide
• Intervention / Treatment: Drug: Infants in the study group (S/B group) will receive surfactant 2.5 mls/kg and Budesonide 0.5 mg (1mL); Drug: Infants in the control group (S/P group) receive placebo (Normal saline 1mL)

Detailed Description

In extremely premature infants who are ventilated there is ongoing lung injury & lung inflammation. This can perpetuate the need for ongoing ventilation and these infants spend much longer in the hospital. The likelihood of chronic lung disease in this susceptible group is very high and they would need oxygen at home. Surfactant instillation has reduced the need for prolonged mechanical ventilation and to an extent the incidence of chronic lung disease (CLD). But many infants develop CLD and need prolonged oxygen treatment, diuretics and inhaled steroids to suppress the inflammation and obstruction of the airways. Some of the severely affected infants need orally administered steroids. The Inestigators propose to provide a dose of steroids instilled along with the surfactant in the very first day of life so as to prevent the vicious and ongoing cascade of lung injury and inflammation. As it is a poorly absorbed steroid and as only one or two doses is proposed to be used there is no effects within the body and it works locally within the lung. This is hoped to reduce CLD and improve long term outcomes. The population most susceptible to CLD is the extreme preterm infant with RDS who needs mechanical ventilation soon after birth. One of the groups will receive the surfactant with saline and the other group will receive the surfactant along with topical steroid. The groups will be followed during the hospital stay. survival along with duration of ventilation, duration of hospital stay and oxygen needs are noted. To study the hoped for long term benefits the investigators would note the long term neuro-development - if they were followed as per hospital policy between 18 months and 26 months. Intra-tracheal instillation of budesonide using surfactant as vehicle would facilitate its delivery to the periphery of the lung and would inhibit lung inflammation.

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: R Kylat, MD; Phone Number: 5206266627; Email: rkylat@arizona.edu

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85719
      • Recruiting
      • University of Arizona
      • Contact: Joanna Schrader; Phone Number: 520-626-6282; Email: jschrader@arizona.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Infants born at < 30+0/7 weeks (23+0 - 29+6/7) gestational age (GA) OR with preterm infants with a birth weight (BW) which is < 1500 gm AND if they have severe respiratory distress syndrome (RDS) (Clinical diagnosis based on the need for mechanical ventilation in preterm infant or if they have radiologic features of RDS along with need for positive distending airway pressure and fractional inspired oxygen (FiO2) > 0.3)

Exclusion Criteria:

1. major congenital defects
2. chromosomal abnormality
3. pneumothorax
4. Known surgical disease
5. Known or suspected congenital heart disease
6. Infant not considered viable by physician
7. Severe sepsis / infections
8. Likely to be extubated within the next 24 hours

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: S/B group- infants; Infants randomized to the study group (S/B group) will receive surfactant and Budesonide - 0.5 mg -1mL	Drug: Infants in the study group (S/B group) will receive surfactant 2.5 mls/kg and Budesonide 0.5 mg (1mL); Infants in the study group (S/B group) will receive surfactant 2.5 mls/kg and Budesonide 0.5 mg (1mL); Other Names: Pulmicort
Placebo Comparator: S/P group- control / placebo comparator; Infants randomized to the control group (S/P group) will receive surfactant and placebo (Normal Saline -1mL)	Drug: Infants in the control group (S/P group) receive placebo (Normal saline 1mL); Infants in the control group (S/P group) will receive surfactant 2.5 mls/kg and placebo (Normal saline 1mL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of combined inflammatory cytokines	Change in inflammatory cytokines /chemokines (interleukin-6, 8, 10 and Tumor Necrosis Factor α (TNF-α) levels	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
chronic lung disease	Supplemental oxygen requirement at 36 weeks corrected gestational age	36 weeks corrected gestational age (CGA)
Mortality	All cause mortality	upto 40 weeks corrected gestational age (CGA)
Ventilator days	duration of ventilation	Upto 40 weeks corrected gestational age (CGA)
Neuro-developmental outcome	Composite Bailey III neuro-developmental score. Scores range overall from 40 to 160 and for Cognitive: 55-145; Language: 47-153; Motor: 46-154; Social-Emotional: 55-145 with lower score for poor outcome and higher score for better outcome	18 - 26 months corrected postnatal age

Collaborators and Investigators

• Sponsor: University of Arizona

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2019
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: May 2, 2022
• First Submitted That Met QC Criteria: May 5, 2022
• First Posted (Actual): May 6, 2022

Study Record Updates

• Last Update Posted (Actual): November 1, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Wounds and Injuries; Infant, Newborn, Diseases; Infant, Premature, Diseases; Thoracic Injuries; Ventilator-Induced Lung Injury; Lung Diseases; Acute Lung Injury; Lung Injury; Bronchopulmonary Dysplasia; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Budesonide; Pulmonary Surfactants
• Other Study ID Numbers: 1811108822

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No