Study to Justify Steroid Use in Preterm Neonates to Prevent

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Bronchopulmonary Dysplasia

Clinical Trial Details

NCT number	NCT03035214
Study type	Interventional
Source	Maadi Military Hospital
Contact	Wael Hamza, MRCP
Email	EL_ZOERY_PERRY@HOTMAIL.COM
Status	Recruiting
Phase	Phase 2
Start date	February 19, 2017
Completion date	December 31, 2017

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT04506619` - Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment With SHP607 in Extremely Premature Infants
Completed	`NCT04936477` - Ventilation-perfusion (V/Q) Ratio and Alveolar Surface Area in Preterm Infants	N/A
Recruiting	`NCT05285345` - Implementation of a Consensus-Based Discharge Protocol for Preterm Infants With Lung Disease
Completed	`NCT03649932` - Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing	Phase 1
Terminated	`NCT02524249` - Early Versus Late Caffeine for ELBW Newborns	N/A
Completed	`NCT02249143` - Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants	N/A
Active, not recruiting	`NCT01632475` - Follow-Up Study of Safety and Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia
Completed	`NCT01460576` - Improving Prematurity-Related Respiratory Outcomes at Vanderbilt	N/A
Completed	`NCT00419588` - Growth of Airways and Lung Tissues in Premature and Healthy Infants
Unknown status	`NCT00254176` - Cysteine Supplementation in Critically Ill Neonates	Phase 2/Phase 3
Completed	`NCT00319956` - Trial II of Lung Protection With Azithromycin in the Preterm Infant	Phase 2
Completed	`NCT00208039` - Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates	N/A
Completed	`NCT00006401` - Inhaled Nitric Oxide for Preventing Chronic Lung Disease in Premature Infants	Phase 3
Terminated	`NCT05030012` - Maintaining Optimal HVNI Delivery Using Automatic Titration of Oxygen in Preterm Infants	N/A
Completed	`NCT00006058` - Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns	N/A
Completed	`NCT00005376` - Premature Birth and Its Sequelae in Women	N/A
Completed	`NCT00011362` - Dexamethasone Therapy in VLBW Infants at Risk of CLD	Phase 3
Completed	`NCT00004805` - Study of the Effect of Four Methods of Cardiopulmonary Resuscitation Instruction on Psychosocial Response of Parents With Infants at Risk of Sudden Death	N/A
Completed	`NCT05152316` - The Baby Lung Study
Recruiting	`NCT04821453` - NAVA vs. CMV Crossover in Severe BPD	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms