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

NCT ID: NCT03035214

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-19
• Study Completion Date: 2017-12-31

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prevention of dysplasia through steroids

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.

Group Type: OTHER

Dexamethasone (Steroids)

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Dexamethasone

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Congenital heart disease
• Major congenital abnormalities

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 30 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maadi Military Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Wael Hamza

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Maadi Military Hospital

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Wael Hamza, MRCP

Role: CONTACT

EL_ZOERY_PERRY@HOTMAIL.COM

Noha F Rashad

Role: CONTACT

noha16880@gmail.com

00201225157339

Facility Contacts

Noha F Rashad

Role: primary

noha16880@gmail.com

00201225157339

Other Identifiers

MaadiPed001

Identifier Type: -

Identifier Source: org_study_id