Brief Title
Study to Justify Steroid Use in Preterm Neonates to Prevent Bronchopulmonary Dysplasia
Official Title
Single Arm Study on Treatment Algorithm to Justify Steroid Use in Selected Preterm Neonates to Prevent Bronchopulmonary Dysplasia
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Infant morbidity
Condition
Bronchopulmonary Dysplasia
Intervention
Dexamethasone (Steroids)
Study Arms / Comparison Groups
Prevention of dysplasia through steroids
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
30
Start Date
February 19, 2017
Completion Date
December 31, 2017
Primary Completion Date
December 31, 2017
Eligibility 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
Gender
All
Ages
N/A - 30 Days
Accepts Healthy Volunteers
No
Contacts
, , [email protected]
Location Countries
Egypt
Location Countries
Egypt
Administrative Informations
NCT ID
NCT03035214
Organization ID
MaadiPed001
Responsible Party
Principal Investigator
Study Sponsor
Maadi Military Hospital
Study Sponsor
, ,
Verification Date
February 2017