Differences in demographics and outcomes based on method of consent for a randomised controlled trial on heat loss prevention in the delivery room.

Objective: Informed consent is standard in research. International guidelines allow for research without prior consent in emergent situations, such as neonatal resuscitation. Research without prior consent was incorporated in the Vermont Oxford Network Heat Loss Prevention Trial.

Primary Outcomes Reporting in Trials (PORTal): a systematic review of inadequate reporting in pediatric randomized controlled trials.

Objective: Conduct a systematic review of pediatric randomized controlled trials (RCTs) published in high-impact journals to assess the reporting of primary outcomes and the psychometric properties of their measures.

Study Design And Setting: Systematic review with screening and simultaneous data extraction conducted by two independent reviewers. Electronic searches of six general medicine and four pediatric journals were conducted in MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL) databases.

Core Outcome Measures in Effectiveness Trials (COMET) initiative: protocol for an international Delphi study to achieve consensus on how to select outcome measurement instruments for outcomes included in a 'core outcome set'.

Background: The Core Outcome Measures in Effectiveness Trials (COMET) initiative aims to facilitate the development and application of 'core outcome sets' (COS). A COS is an agreed minimum set of outcomes that should be measured and reported in all clinical trials of a specific disease or trial population. The overall aim of the Core Outcome Measurement Instrument Selection (COMIS) project is to develop a guideline on how to select outcome measurement instruments for outcomes included in a COS.

Study protocol for multicentre randomized controlled trial of HeLP (Heat Loss Prevention) in the delivery room.

Introduction: Immediate postnatal hypothermia is an independent risk factor for death in premature newborns. Three randomized controlled trials (RCTs) and five historical controlled trials show statistically significant differences in admission temperature between infants wrapped in occlusive skin wrap and unwrapped infants. This paper presents a study protocol for The Vermont Oxford Network (VON) Heat Loss Prevention (HeLP) Trial, a multicentre RCT of two interventions (standard of care vs.