NCT03035214

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

Single Arm Study on Treatment Algorithm to Justify Steroid Use in Selected Preterm Neonates to Prevent Bronchopulmonary Dysplasia

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Maadi Military Hospital · Other Government
• Sex: All
• Age: 1 Day – 30 Days
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective study. 30 Preterm infants admitted to neonatal intensive care units of Maadi, Ghamra military hospitals, and Ain Shams University hospitals, will be prospectively enrolled within 24 hours after birth. Daily evaluation of oxygen histograms with measurement of the cumulative time of oxygen saturations below 80%, (risk of hypoxemia and potential tissue hypoxia), and arterial oxygen saturations Sao2 above 95% (potential risk of hyperoxia and increased oxidative stress). Evaluation window will be on a weekly basis as long as the infant is on oxygen support and by applying oxygen tolerance test. The treating clinical team will be blinded to all results of Oxygen tolerance test.

Conditions

• Bronchopulmonary Dysplasia

Interventions

Type	Name	Description
DRUG	Dexamethasone (Steroids)	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.

Timeline

• Start date: 2017-02-19
• Primary completion: 2017-12-31
• Completion: 2017-12-31
• First posted: 2017-01-27
• Last updated: 2017-02-23

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study