Multi-centre, randomised non-inferiority trial of early treatment versus expectant management of patent ductus arteriosus in preterm infants (the BeNeDuctus trial): statistical analysis plan
AbstractBackgroundControversy exists about the optimal management of a patent ductus arteriosus (PDA) in preterm infants. A persistent PDA is associated with neonatal mortality and morbidity, but causality remains unproven. Although both pharmacological and/or surgical treatment are effective in PDA closure, this has not resulted in an improved neonatal outcome. In most preterm infants, a PDA will eventually close spontaneously, hence PDA treatment potentially increases the risk of iatrogenic adverse effects. Therefore, expectant management is gaining interest, even in the absence of convincing evidence to support this str...
Source: Trials - September 15, 2021 Category: Research Source Type: clinical trials

Baby-OSCAR: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies —a statistical analysis plan for short-term outcomes
ConclusionThis paper describes the statistical analysis plan for short-term health outcomes of the trial, including the analysis principles, definitions of important outcomes, methods for primary analysis, pre-specified subgroup analysis, and secondary analysis. The plan was finalised prior to completion of short-term follow-up.Trial registrationISRCTN registryISRCTN84264977. Registered on 15 September 2010. (Source: Trials)
Source: Trials - May 26, 2021 Category: Research Source Type: clinical trials

Prone Versus Supine Positioning and the Impact on Bronchopulmonary Dysplasia in Very Low Birth Weight Infants.
Conditions:   Prone Positioning;   Bronchopulmonary Dysplasia Intervention:   Other: Prone positioning for a total of 6 hours daily Sponsor:   Montefiore Medical Center Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - May 18, 2021 Category: Research Source Type: clinical trials

Lung Ultrasound for Early Identification of Preterm Infants With Bronchopulmonary Dysplasia
Condition:   Bronchopulmonary Dysplasia (BPD) Intervention:   Sponsors:   Adel Mohamed;   Mount Sinai Hospital, Canada;   Health Sciences Centre, Winnipeg, Manitoba Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - February 16, 2021 Category: Research Source Type: clinical trials