Development of the individual participant data integrity tool for assessing the integrity of randomised trials using individual participant data.

Increasing integrity concerns in medical research have prompted the development of tools to detect untrustworthy studies. Existing tools primarily assess published aggregate data (AD), though scrutiny of individual participant data (IPD) is often required to detect trustworthiness issues. Thus, we developed the IPD Integrity Tool for detecting integrity issues in randomised trials with IPD available.

The Individual Participant Data Integrity Tool for assessing the integrity of randomised trials.

Increasing concerns about the trustworthiness of research have prompted calls to scrutinise studies' Individual Participant Data (IPD), but guidance on how to do this was lacking. To address this, we developed the IPD Integrity Tool to screen randomised controlled trials (RCTs) for integrity issues. Development of the tool involved a literature review, consultation with an expert advisory group, piloting on two IPD meta-analyses (including 73 trials with IPD), preliminary validation on 13 datasets with and without known integrity issues, and evaluation to inform iterative refinements.

Aspects on Oxygenation in Preterm Infants before, Immediately after Birth, and Beyond.

Background: Oxygen is crucial for life but too little (hypoxia) or too much (hyperoxia) may be fatal or cause lifelong morbidity.

Summary: In this review, we discuss the challenges of balancing oxygen control in preterm infants during fetal development, the first few minutes after birth, in the neonatal intensive care unit and after hospital discharge, where intensive care monitoring and response to dangerous oxygen levels is more often than not, out of reach with current technologies and services.

Key Messages: Appropriate oxygenation is critically important even from before birth, but at no time is the need to strike a balance more important than during the first few minutes after birth, when body physiology is changing at its most rapid pace.

Air or Oxygen for Infant Resuscitation: A Prospective Cohort Study of Moderate-Late Preterm Infants Requiring Delivery Room Resuscitation.

Introduction: Due to concerns of oxidative stress and injury, most clinicians currently use lower levels of fractional inspired oxygen (FiO2, 0.21-0.3) to initiate respiratory support for moderate to late preterm (MLPT, 32-36 weeks gestation) infants at birth.

Short, medium, and long deferral of umbilical cord clamping compared with umbilical cord milking and immediate clamping at preterm birth: a systematic review and network meta-analysis with individual participant data.

Background: Deferred (also known as delayed) cord clamping can improve survival of infants born preterm (before 37 weeks of gestation), but the optimal duration of deferral remains unclear. We conducted a systematic review and individual participant data network meta-analysis with the aim of comparing the effectiveness of umbilical cord clamping strategies with different timings of clamping or with cord milking for preterm infants.

Methods: We searched medical databases and trial registries from inception until Feb 24, 2022 (updated June 6, 2023) for randomised controlled trials comparing cord clamping strategies for preterm infants.

Deferred cord clamping, cord milking, and immediate cord clamping at preterm birth: a systematic review and individual participant data meta-analysis.

Background: Umbilical cord clamping strategies at preterm birth have the potential to affect important health outcomes. The aim of this study was to compare the effectiveness of deferred cord clamping, umbilical cord milking, and immediate cord clamping in reducing neonatal mortality and morbidity at preterm birth.

Methods: We conducted a systematic review and individual participant data meta-analysis.

PROspective Meta-analysis Of Trials of Initial Oxygen in preterm Newborns (PROMOTION): Protocol for a systematic review and prospective meta-analysis with individual participant data on initial oxygen concentration for resuscitation of preterm infants.

Background: Clinicians favour low oxygen concentrations when resuscitating preterm infants immediately after birth despite inconclusive evidence to support this practice. Prospective meta-analysis (PMA) is a novel approach where studies are identified as eligible for inclusion in the meta-analysis before their results are known.

Aims: To explore whether high (60%) or low (30%) oxygen is associated with greater efficacy and safety for the initial resuscitation (immediately after birth) of preterm infants born at <29 weeks' gestation.

The quest for optimum oxygenation during newborn delivery room resuscitation: Is it the baby or is it us?

Achieving "normal oxygenation" in sick newborn infants requiring resuscitation is one of the most difficult and incompletely informed practices in neonatal care. Suboptimal oxygenation, whether too little or too much, has profound repercussions, including death. In the last two decades, clinicians have lost equipoise for the use of higher oxygen strategies due to concerns of hyperoxia but emerging evidence suggests that lower oxygen strategies may also be as detrimental, especially in infants with pulmonary pathologies such as those born at the cusp of viability.

Oxygen for the delivery room respiratory support of moderate-to-late preterm infants. An international survey of clinical practice from 21 countries.

Aim: The aim of this study was to determine clinician opinion regarding oxygen management in moderate-late preterm resuscitation.

Methods: An anonymous online questionnaire was distributed through email/social messaging platforms to neonatologists in 21 countries (October 2020-March 2021) via REDCap.

Results: Of the 695 respondents, 69% had access to oxygen blenders and 90% had pulse oximeters.

Oxygen saturation (SpO2) targeting for newborn infants at delivery: Are we reaching for an impossible unknown?

For more than 200 years, pure oxygen was given ad libitum to newborn infants requiring resuscitation. Due to oxidative stress and injury concerns, a paradigm shift towards using "less" oxygen, including air (21% oxygen) instead of pure (100%) oxygen, occurred about twenty years ago. A decade later, clinicians were advised to adjust fractional inspired oxygen (FiO) to target oxygen saturations (SpO) that were derived from spontaneously breathing, healthy, mature infants.