Closing patent ductus arteriosus in preterm babies by using a risk-based score

Phase 3

Completed

• Conditions: Patent ductus arteriosus, preterm infants; Circulatory System; Patent ductus arteriosus

• Registration Number: ISRCTN13281214
• Lead Sponsor: Royal College of Surgeons in Ireland

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33069668/ results (added 20/10/2020) 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/33310351/ cohort study (added 16/12/2020) 2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34522836/ RCT protocol (added 21/09/2021) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/35585179/ (added 18/08/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-26
• Study Completion: 2020-08-01
• Last Update Posted: 28 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

All infants aged less than 29 weeks admitted to the NICU with a PDA identified on echocardiography between 36 and 48 hours of life will be eligible for inclusion. A comprehensive assessment of PDA significance will be performed using echocardiography to derive a PDA risk score based using a mathematical formula:
(Gestation in weeks × -1.304) + (PDA diameter in mm × 0.781) + (Left ventricular output in ml/kg/min × 0.008) + (maximum PDA velocity in m/s × -1.065) + (LV a` wave in cm/s × -0.470) + 41, where 41 is the constant of the formula

Infants with a risk score = 5.0 are deemed to be at high risk of developing CLD/death and will be randomised to either arm.

Exclusion Criteria

1. Lack of consent or study investigators to carry out echocardiogram examination
2. Lethal congenital abnormality or obvious syndrome
3. Pulmonary hypoplasia
4. Known or suspected NEC
5. Thrombocytopenia: platelet count < 100/mm2
6. Impaired renal function creatinine > 100 µmol/L; and/or oliguria < 1ml/kg/hour
7. Culture positive sepsis
8. Congenital heart disease other than a PDA or a patent foramen ovale
9. Active bleeding including grade 3 or higher IVH or gastrointestinal haemorrhage

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Chronic lung disease, defined as the need for oxygen at 36 weeks corrected age, and/or death before discharge. This will be assessed prior to hospital discharge at 36 weeks corrected age.