Status:
COMPLETED
Timing of Surgical PDA Ligation and Neonatal Outcomes
Lead Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Conditions:
Patent Ductus Arteriosus
Patent Ductus Arteriosus - Delayed Closure
Eligibility:
All Genders
1-6 years
Brief Summary
Patent ductus arteriosus (PDA) is common among very preterm infants. If pharmacological closure is ineffective or contraindicated, surgical ligation may be required. Access to cardiothoracic surgery m...
Detailed Description
Patent ductus arteriosus (PDA) is a common condition among preterm infants, with an estimated incidence of 60% in extremely low birth weight infants (ELBW). Several factors, such as the relative oxyge...
Eligibility Criteria
Inclusion
- Gestational age \<32 weeks' gestation
- Surgical PDA ligation
Exclusion
- Major congenital malformations
- Congenital heart disease
Key Trial Info
Start Date :
September 25 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT04126512
Start Date
September 25 2019
End Date
December 31 2019
Last Update
June 9 2020
Active Locations (2)
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1
S. Orsola-Malpighi University Hospital
Bologna, Emilia-Romagna, Italy, 40138
2
The Rosie Hospital, Cambridge University Hospitals
Cambridge, United Kingdom, CB2 0SW