CompletedNot Applicable

Timing of Surgical PDA Ligation and Neonatal Outcomes

Italy, United Kingdom78 participantsStarted 2019-09-25

Plain-language 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.

Who can participate

Age range

1 Day – 6 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Gestational age \<32 weeks' gestation * Surgical PDA ligation Exclusion Criteria: * Major congenital malformations * Congenital heart disease

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

PDA ligation timing

Timeframe: From birth up to hospital discharge (average period: 6 months)

Mortality

Timeframe: From birth up to hospital discharge (average period: 6 months)

Bronchopulmonary dysplasia

Timeframe: 36 weeks' post-conceptional age

Trial details

NCT IDNCT04126512

SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-12-31

View on ClinicalTrials.gov More Patent Ductus Arteriosus trials