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

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ClinicalTrials.gov Identifier: NCT03035214
Recruitment Status : Unknown
Verified February 2017 by Dr. Wael Hamza, Maadi Military Hospital.
Recruitment status was:  Recruiting
First Posted : January 27, 2017
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Wael Hamza, Maadi Military Hospital

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.


Condition or disease Intervention/treatment Phase
Bronchopulmonary Dysplasia Drug: Dexamethasone (Steroids) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Arm Study on Treatment Algorithm to Justify Steroid Use in Selected Preterm Neonates to Prevent Bronchopulmonary Dysplasia
Actual Study Start Date : February 19, 2017
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2017


Arm Intervention/treatment
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.
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.
Other Name: Dexamethasone




Primary Outcome Measures :
  1. Infant morbidity [ Time Frame: 30 days ]


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Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

All preterm neonates admitted to the neonatal intensive care unit will be considered eligible for inclusion. Fully informed written consent from parents of all eligible infants will be sought prior to enrollment. Infants with major congenital abnormalities, cardiac lesions other than Patent ductus arteriosus, and lung hypoplasia will be excluded from this study.

Inclusion criteria:

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

Exclusion criteria:

  • Congenital heart disease
  • Major congenital abnormalities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035214


Contacts
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Contact: Wael Hamza, MRCP EL_ZOERY_PERRY@HOTMAIL.COM
Contact: Noha F Rashad 00201225157339 noha16880@gmail.com

Locations
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Egypt
Maadi Military Hospital Recruiting
Cairo, Egypt
Contact: Noha F Rashad    00201225157339    noha16880@gmail.com   
Sponsors and Collaborators
Maadi Military Hospital

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Responsible Party: Dr. Wael Hamza, Principal investigator, Maadi Military Hospital
ClinicalTrials.gov Identifier: NCT03035214     History of Changes
Other Study ID Numbers: MaadiPed001
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Bronchopulmonary Dysplasia
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action