Study to Justify Steroid Use in Preterm Neonates to Prevent Bronchopulmonary Dysplasia

NCT03035214 | Unknown Phase 2 FDA Drug

• 1 other identifier: MaadiPed001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Most preterm babies require supplemental oxygen for a variable period of time, up to several weeks or months after birth. The aim of oxygen therapy is to achieve adequate oxygen supply to the tissues without causing oxygen toxicity and oxidative stress. The current routine monitoring relies on oxygen saturation by pulse oximetry without identifying the underlying pathology, as lung parenchyma and pulmonary vascular disease can be contributed in pathophysiology at variable degrees. Steroids usage for prevention of Bronchopulmonary dysplasia also has been shown to have adverse neurodevelopmental outcome. Available data are conflicting and inconclusive; clinicians must use their own clinical judgment to balance the adverse effects of Bronchopulmonary dysplasia with the potential adverse effects of treatments for each individual patient. Very low birth weight infants who remain on mechanical ventilation after 1 to 2 weeks of age are at very high risk of developing Bronchopulmonary dysplasia. When considering corticosteroid therapy for such an infant, clinicians might conclude that the risks of a short course of glucocorticoid therapy to prevent Bronchopulmonary dysplasia are warranted.

Conditions

Bronchopulmonary Dysplasia

Outcome Measures

Primary Outcomes (1)

• Infant morbidity

  30 days

Study Arms (1)

Prevention of dysplasia through steroids

OTHER

Failure of lung tolerance to oxygen reduction will be defined as oxygen saturation 80 to 87% for 5 minutes, or \<80% for 1 minute, then inspired oxygen will be increased back to the base line. This will be considered as an early predictor of evolving bronchopulmonary dysplasia. If there is no hypoventilation, dexamethasone will be given 0.25 mg/ kg/ d divided twice for 5 days intravenous.

Drug: Dexamethasone (Steroids)

Interventions

Dexamethasone (Steroids) DRUG

Is to describe the use of integrated assessment of respiratory physiology using Targeted Neonatal Echocardiography, assessment of optimal Functional Residual Capacity and the tolerance of lung oxygen uptake at different oxygen levels, and hence early prediction of Bronchopulmonary Dysplasia and the underlying pathophysiology by periodic application of the oxygen tolerance test; which may help early targeted treatment of this common disease.

Also known as: Dexamethasone

Prevention of dysplasia through steroids

Eligibility Criteria

• Age: 1 Day - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \< 36 week gestation pre-terms, not having major congenital anomalies

You may not qualify if:

• Congenital heart disease
• Major congenital abnormalities

Sponsors & Collaborators

• Maadi Military Hospital: lead

Study Sites (1)

Maadi Military Hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Interventions

Dexamethasone; Steroids

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

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Wael Hamza, MRCP

CONTACT

EL_ZOERY_PERRY@HOTMAIL.COM

Noha F Rashad

CONTACT

00201225157339; noha16880@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 22, 2017
• First Posted: January 27, 2017
• Study Start: February 19, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)