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Timing of Surgical PDA Ligation and Neonatal Outcomes

NCT04126512 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 78

Last updated 2020-06-09

No results posted yet for this study

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 may influence the timing of ligation, with possible long-term clinical effects. This study protocol aims to assess the impact of different surgical management of PDA (bedside surgery vs. referral to a cardiac surgery centre) on ligation timing and neonatal clinical outcomes in two tertiary Neonatal Intensive Care Units.

Infants born at St. Orsola-Malpighi University Hospital, Bologna, Italy (group 1, bedside ligation) and Cambridge University Hospital, Cambridge, UK (group 2, referred to an off-site specialist paediatric cardiac surgical centre) who underwent PDA ligation between 2007 and 2018 will be included in this retrospective cohort study if fulfilling the following criteria: gestational age (GA) \<32 weeks, birth weight (BW) \<1500 g, inborn, absence of major malformation or congenital heart disease. Neonatal clinical outcomes will be collected and compared between the 2 groups.

Conditions

  • Patent Ductus Arteriosus
  • Patent Ductus Arteriosus - Delayed Closure
  • Patent Ductus Arteriosus After Premature Birth

Interventions

OTHER

PDA ligation

PDA ligation was performed at bedside, if a local cardiac surgery team was available, or in the case this service was not available, infants were referred to off-site specialist paediatric cardiac surgical services, where PDA ligation was performed.

Sponsors & Collaborators

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Principal Investigators

  • Silvia Martini, MD · Sant'Orsola-Malpighi University Hospital

Eligibility

Min Age
1 Day
Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-25
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Italy
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04126512 on ClinicalTrials.gov