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Clinical Trials/EUCTR2010-023777-19-BE
EUCTR2010-023777-19-BE
Active, not recruiting
Not Applicable

Systemic Hydrocortisone to Prevent Bronchopulmonary Dysplasia in Preterm INfants: the SToP-BPD Study. - SToP-BPD Study

Z Brussel0 sites400 target enrollmentOctober 10, 2011
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ConditionsBronchopulmonary dysplasiaMedDRA version: 14.0Level: PTClassification code 10006475Term: Bronchopulmonary dysplasiaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
DrugsSolu-Cortef

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bronchopulmonary dysplasia
Sponsor
Z Brussel
Enrollment
400
Status
Active, not recruiting
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 10, 2011
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Z Brussel

Eligibility Criteria

Inclusion Criteria

  • •Preterm infants with a gestational age \< 30 wks and/or birth weight \< 1250 g, ventilator dependency at 7\-14 days postnatal age, a respiratory index (RI \= MAwP x FiO2\) of \= 3\.5 for more than 12 h/day for at least 48 hours, ensuring adequate oxygen saturation (85\-95%) and pCO2 values in premature infants (5\.0\-7\.5 kPa).
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 100
  • •F.1\.2 Adults (18\-64 years) no
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •Infants with chromosomal defects (e.g. trisomy 13, 18, 21\) or major congenital malformations that compromise lung function (e.g. surfactant protein deficiencies, congenital diaphragmatic hernia), result in chronic ventilation (e.g. Pierre Robin sequence), or increase the risk of death or adverse neurodevelopmental outcome (congenital cerebral malformations) will be excluded.
  • •Also infants who received dexamethasone or hydrocortisone for the sole purpose of improving lung function and respiratory status prior to inclusion, will be excluded.

Outcomes

Primary Outcomes

Not specified

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