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Clinical Trials/EUCTR2010-023777-19-NL
EUCTR2010-023777-19-NL
Active, not recruiting
Phase 1

Systemic Hydrocortisone To Prevent Bronchopulmonary Dysplasia in preterm infants: the SToP-BPD study - SToP-BPD

Academic Medical Center0 sitesJuly 20, 2011
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Conditionsbronchopulmonary dysplasiaMedDRA version: 12.1Level: LLTClassification code 10006475Term: Bronchopulmonary dysplasia
Drugshydrocortisone

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
bronchopulmonary dysplasia
Sponsor
Academic Medical Center
Status
Active, not recruiting
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 20, 2011
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Academic Medical Center

Eligibility Criteria

Inclusion Criteria

  • •Preterm infants with a gestational age \< 30 wks and/or birth weight \< 1250 g, ventilator dependent at 7\-14 days PNA with a respiratory index (MAwP x FiO2\) of \= 3\.5\. This index should be present for more than 12 h/day for at least 48 hours and must ensure normal oxygen saturation (86\-94%) and pCO2 values in premature infants (5\.0\-7\.0 kPa).
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range:
  • •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 are expected to compromise lung function (e.g. surfactant protein deficiencies, congenital diaphragmatic hernia) or 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.

Outcomes

Primary Outcomes

Not specified

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