Timing of Surgical PDA Ligation and Neonatal Outcomes

NCT04126512 | Completed

• 1 other identifier: PDA-lig-SO-CAM
• Study Type: observational
• Target: 78
• Locations: 2 countries
• Sites: 2

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 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

Outcome Measures

Primary Outcomes (3)

• PDA ligation timing

  Days of life at PDA ligation in SOM group compared to the CUH group

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

• Mortality

  Any decrease in the mortality rate in the SOM group compared to the CUH group

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

• Bronchopulmonary dysplasia

  Any decrease in the rate of bronchopulmonary dysplasia in the SOM group compared to the CUH group

  36 weeks' post-conceptional age

Secondary Outcomes (8)

• Intraventricular haemorrhage (IVH)

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

• Periventricular leukomalacia (PVL)

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

• Necrotizing enterocolitis (NEC)

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

• Retinopathy of prematurity (ROP)

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

• Oxygen need at discharge

  Hospital discharge (average age: 6 months of life)

Study Arms (2)

Bedside ligation

Infants admitted to St. Orsola-Malpighi Hospital (SOM) NICU had their PDA ligated at bedside, with a timing of surgery dependent on the time schedule of the surgeons and anaesthesiologists.

Other: PDA ligation

Referred to specialist paediatric cardiac surgery centre

Due to the unavailability of local cardiac surgery, infants admitted to the Cambridge University Hospital (CUH) NICU were referred to specialist paediatric cardiac surgical centres, where PDA ligation was performed. In these cases, the surgical timing depended on both bed availability at the referral centre and the availability of the neonatal transfer team.

Other: PDA ligation

Interventions

PDA ligation OTHER

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.

Bedside ligation; Referred to specialist paediatric cardiac surgery centre

Eligibility Criteria

• Age: 1 Day - 6 Months
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants born at the Neonatal Intensive Care Unit (NICU) of Cambridge University Hospital (CUH, Cambridge, UK) and of St. Orsola-Malpighi Hospital (SOM, Bologna, Italy) between 01/01/2007 and 30/06/2018

You may qualify if:

• Gestational age \<32 weeks' gestation
• Surgical PDA ligation

You may not qualify if:

• Major congenital malformations
• Congenital heart disease

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (2)

S. Orsola-Malpighi University Hospital

Bologna, Emilia-Romagna, 40138, Italy

Location

The Rosie Hospital, Cambridge University Hospitals

Cambridge, CB2 0SW, United Kingdom

Location

MeSH Terms

Conditions

Ductus Arteriosus, Patent

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Silvia Martini, MD

  Sant'Orsola-Malpighi University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 15, 2019
• Study Start: September 25, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); IT (1)