Study to investigate the optimal treatment of a patent ductus arteriosus (Botalli) in preterm newborn infants.

Phase 1

• Conditions: Patent ductus arteriosus in the preterm infant; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2017-001376-28-BE
• Lead Sponsor: Radboud University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-13
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 564

Inclusion Criteria

- Gestational age < 28 completed weeks
- Postnatal age < 72 hours
- PDA diameter > 1.5 mm and ductal (predominantly) left-to-right shunt
- Signed informed consent obtained from parent(s) or representative(s)

Are the trial subjects under 18? yes
Number of subjects for this age range: 564
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Contraindication for administration of cyclooxygenase-inhibitors (COXi)
- Use of COXi prior to randomization
- Persistent pulmonary hypertension (ductal right-to-left shunt ?33% of cardiac cycle)
- Congenital heart defect, other than PDA and/or PFO
- Life-threatening congenital defects
- Chromosomal abnormalities and/or congenital anomalies associated with abnormal neurodevelopmental outcome

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate whether in preterm infants, born at a GA less than 28 completed weeks, with a PDA (diameter >1.5 mm) an expectative management is not inferior to early treatment with regard to the composite of mortality and/or NEC (Bell stage ? IIa) and/or BPD at a PMA of 36 weeks.;Secondary Objective: Not applicable;<br> Primary end point(s): The primary endpoint is the composite of:<br> - Mortality at a postmenstrual age of = 36 completed weeks, and/or<br> - NEC (Bell stage = IIa) at a postmenstrual age of = 36 completed weeks, and/or<br> - BPD, defined as the need for supplemental oxygen need at a postmenstrual age of 36 completed weeks<br> ;Timepoint(s) of evaluation of this end point: Postmenstrual age of 36 completed weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary endpoints are short term sequela of cardiovascular failure, adverse effects during the stay in the hospital and long term neurodevelopmental consequences assessed at a corrected age of 2 years.;<br> Timepoint(s) of evaluation of this end point: - During the stay in hospital<br> - At a corrected age of 24 months<br>