Developing a core outcome set for assessing interventions and care for parents after neonatal death in high-income countries (iCHOOSE Neonatal study): protocol for a mixed-methods study.

Introduction: Neonatal death exerts long-lasting impact on parents' mental health, finances and relationships, and the wider family. There is national and international momentum to evaluate interventions to support parents after the death of a baby. Core Outcome Sets (COSs) provide a minimum set of outcomes, agreed by stakeholders to be important, which should be evaluated in all studies to support evidence syntheses and identification of the most effective interventions.

Study protocol for the development and pilot-testing of a Self-assessment tool for the implementation of the European Standards of Care for Newborn Health (ESCNH).

Introduction: In Europe, disparities exist in having access to optimal neonatal care. With the European Standards of Care for Newborn Health (ESCNH), evidence-based reference standards are available which provide guidance to improve the care for preterm and ill newborns. To support healthcare professionals (HCPs) and hospital/clinic management in identifying the extent of ESCNH implementation, a feasible assessment tool is required.

Developments in the Design, Conduct, and Reporting of Child Health Trials.

To identify priority areas to improve the design, conduct, and reporting of pediatric clinical trials, the international expert network, Standards for Research (StaR) in Child Health, was assembled and published the first 6 Standards in Pediatrics in 2012. After a recent review summarizing the 247 publications by StaR Child Health authors that highlight research practices that add value and reduce research "waste," the current review assesses the progress in key child health trial methods areas: consent and recruitment, containing risk of bias, roles of data monitoring committees, appropriate sample size calculations, outcome selection and measurement, and age groups for pediatric trials. Although meaningful change has occurred within the child health research ecosystem, measurable progress is still disappointingly slow.

COHESION: a core outcome set for the treatment of neonatal encephalopathy.

Background: Heterogeneity in outcomes reported in trials of interventions for the treatment of neonatal encephalopathy (NE) makes evaluating the effectiveness of treatments difficult. Developing a core outcome set for NE treatment would enable researchers to measure and report the same outcomes in future trials. This would minimise waste, ensure relevant outcomes are measured and enable evidence synthesis.

Multi-Round versus Real-Time Delphi survey approach for achieving consensus in the COHESION core outcome set: a randomised trial.

Background: Delphi surveys are commonly used to prioritise critical outcomes in core outcome set (COS) development. This trial aims to compare a three-round (Multi-Round) Delphi (MRD) with a Real-Time Delphi (RTD) in the prioritisation of outcomes for inclusion in a COS for neonatal encephalopathy treatments and explore whether 'feedback', 'iteration', and 'initial condition' effects may occur in the two survey methods.

Methods: We recruited 269 participants (parents/caregivers, healthcare providers and researchers/academics) of which 222 were randomised to either the MRD or the RTD.

How to reach agreement: the impact of different analytical approaches to Delphi process results in core outcomes set development.

Background: Core outcomes sets are increasingly used to define research outcomes that are most important for a condition. Different consensus methods are used in the development of core outcomes sets; the most common is the Delphi process. Delphi methodology is increasingly standardised for core outcomes set development, but uncertainties remain.

National priority setting partnership using a Delphi consensus process to develop neonatal research questions suitable for practice-changing randomised trials in the UK.

Background: The provision of neonatal care is variable and commonly lacks adequate evidence base; strategic development of methodologically robust clinical trials is needed to improve outcomes and maximise research resources. Historically, neonatal research topics have been selected by researchers; prioritisation processes involving wider stakeholder groups have generally identified research themes rather than specific questions amenable to interventional trials.

Objective: To involve stakeholders including parents, healthcare professionals and researchers to identify and prioritise research questions suitable for answering in neonatal interventional trials in the UK.

National priority setting partnership using a Delphi consensus process to develop neonatal research questions suitable for practice-changing randomised trials in the United Kingdom.

Introduction: Methodologically robust clinical trials are required to improve neonatal care and reduce unwanted variations in practice. Previous neonatal research prioritisation processes have identified important research themes rather than specific research questions amenable to clinical trials. Practice-changing trials require well-defined research questions, commonly organised using the Population, Intervention, Comparison, Outcome (PICO) structure.

Use of parenteral nutrition in the first postnatal week in England and Wales: an observational study using real-world data.

Background: Parenteral nutrition (PN) is used to provide supplemental support to neonates while enteral feeding is being established. PN is a high-cost intervention with beneficial and harmful effects. Internationally, there is substantial variation in how PN is used, and there are limited contemporary data describing use across Great Britain.

Nutrition for the micro preemie: Beyond milk.

Nutritional support is a fundamental component of the care of the extremely preterm infant, including the "micro preemie" (here defined as a baby born weighing less than 500 g), but goes beyond considerations of milk as a food. This is because milk from an infant's own mother, unlike currently available substitutes, additionally provides invaluable non-nutritive benefits. Nutritional support requires suitable devices or techniques to administer nutrients enterally or intravenously, products shown to be safe in preterm populations, and efficacy demonstrated in respect of important functional outcomes.

Standardized Outcome Measures for Preterm and Hospitalized Neonates: An ICHOM Standard Set.

Introduction: Approximately, one in ten infants is born preterm or requires hospitalization at birth. These complications at birth have long-term consequences that can extend into childhood and adulthood. Timely detection of developmental delay through surveillance could enable tailored support for these babies and their families.

Outcomes in relation to early parenteral nutrition use in preterm neonates born between 30 and 33 weeks' gestation: a propensity score matched observational study.

Objective: To evaluate whether in preterm neonates parenteral nutrition use in the first 7 postnatal days, compared with no parenteral nutrition use, is associated with differences in survival and other important morbidities. Randomised trials in critically ill older children show that harms, such as nosocomial infection, outweigh benefits of early parenteral nutrition administration; there is a paucity of similar data in neonates.

Design: Retrospective cohort study using propensity matching including 35 maternal, infant and organisational factors to minimise bias and confounding.

Late Administration of Surfactant May Increase the Risk of Patent Ductus Arteriosus.

Early rescue surfactant is the most effective way of administering surfactant but many infants still receive surfactant later. Our aim was to explore the association between timing of surfactant administration and the development of patent ductus arteriosus and other neonatal morbidities. This retrospective study analyzed 819 preterm infants under 30 weeks of gestational age and under 1,500 g.

Interventions to improve quantitative measures of parent satisfaction in neonatal care: a systematic review.

Objective: Interventions improving parent satisfaction can reduce parent stress, may improve parent-infant bonding and infant outcomes. Our objective was to systematically review neonatal interventions relating to parents of infants of all gestations where an outcome was parent satisfaction.

Methods: We searched the databases MEDLINE, EMBASE, PsychINFO, Cochrane Central Register of Controlled Trials, CINAHL, HMIC, Maternity and Infant Care between 1 January 1946 and 1 October 2017.

Adding value to core outcome set development using multimethod systematic reviews.

Trials evaluating the same interventions rarely measure or report identical outcomes. This limits the possibility of aggregating effect sizes across studies to generate high-quality evidence through systematic reviews and meta-analyses. To address this problem, core outcome sets (COS) establish agreed sets of outcomes to be used in all future trials.

Core outcomes in neonatology: development of a core outcome set for neonatal research.

Background: Neonatal research evaluates many different outcomes using multiple measures. This can prevent synthesis of trial results in meta-analyses, and selected outcomes may not be relevant to former patients, parents and health professionals.

Objective: To define a core outcome set (COS) for research involving infants receiving neonatal care in a high-income setting.

What topics should we teach the parents of admitted neonates in the newborn care unit in the resource-limited setting - a Delphi study.

Background: In resource-limited settings, such as Rwanda, health care profession (HCP) to neonate ratios are low, and therefore caregivers play a significant role in providing care for their admitted neonates. To provide such Family Integrated Care, caregivers need knowledge, skills, and confidence. The objective of this study was to identify consensus from key stakeholders regarding the priority topics for a "parental neonatal curriculum.

Outcomes following early parenteral nutrition use in preterm neonates: protocol for an observational study.

Introduction: Preterm babies are among the highest users of parenteral nutrition (PN) of any patient group, but there is wide variation in commencement, duration, and composition of PN and uncertainty around which groups will benefit from early introduction. Recent studies in critically unwell adults and children suggest that harms, specifically increased rates of nosocomial infection, outweigh the benefits of early administration of PN. In this study, we will describe early PN use in neonatal units in England, Wales and Scotland.

Inconsistent outcome reporting in large neonatal trials: a systematic review.

Objective: Inconsistent outcome selection and reporting in clinical trials are important sources of research waste; it is not known how common this problem is in neonatal trials. Our objective was to determine whether large clinical trials involving infants receiving neonatal care report a consistent set of outcomes, how composite outcomes are used and whether parents or former patients were involved in outcome selection.

Design: A literature search of CENTRAL, CINAHL, EMBASE and MEDLINE was conducted; randomised trials published between 1 July 2012 and 1 July 2017 and involving at least 100 infants in each arm were included.