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Introduction Cardiorespiratory monitoring is used in the neonatal intensive care unit (NICU) to assess the clinical status of newborn infants and detect critical deteriorations in cardiorespiratory function. Currently, heart rate (HR) is monitored by electrocardiography (ECG) and respiration by chest impedance (CI). Disadvantages of current monitoring techniques are usage of wired adhesive electrodes which may damage the skin and hinder care. The Bambi® belt is a wireless and non-adhesive alternative that enables cardiorespiratory monitoring by measuring electrical activity of the diaphragm via transcutaneous electromyography. A previous study showed feasibility of the Bambi® belt and this study compares the belt performance to ECG and CI.Methods and analysis This multicentre non-inferiority paired study will be performed in the NICU of the Máxima Medical Center (MMC) in Veldhoven and the Emma Children’s Hospital, Amsterdam University Medical Centre (AmsterdamUMC) in Amsterdam, The Netherlands. 39 infants in different postmenstrual age groups (minimally 10 infants32 weeks) will be recruited. These infants will be monitored with the Bambi® belt in addition to standard ECG and CI for 24 hours. The primary outcome is the HR, studied with three criteria: (1) the limits of agreement of the HR measurements in terms of the second-to-second difference in the HR between the belt and standard ECG, (2) the detection of cardiac events consisting of bradycardia and tachycardia and (3) the quality of HR-monitoring. The secondary outcome is the respiratory rate (RR), studied with the criteria (1) agreement in RR-trend monitoring, (2) apnoea and tachypnoea detection and (3) reliable registrations.Ethics and dissemination This protocol was approved by the Medical Ethical Committee of the MMC and the Central Committee for Human Research. The MMC started patient recruitment in July and the AmsterdamUMC in August 2021. The results will be presented at conferences and published in peer-reviewed journals.Trial registration number NL9480.

Background: Although most preterm infants breathe at birth, their respiratory drive is weak and supplemental oxygen is often needed to overcome hypoxia. This could in turn lead to hyperoxia. To reduce the risk of hyperoxia, currently an initial low oxygen concentration (21–30%) is recommended during stabilization at birth, accepting the risk of a hypoxic period. However, hypoxia inhibits respiratory drive in preterm infants. Starting with a higher level of oxygen could lead to a shorter duration of hypoxia by stimulating breathing effort of preterm infants, and combined with subsequent titration based on oxygen saturation, prolonged hyperoxia might be prevented.Study design: This multi-center randomized controlled trial will include 50 infants with a gestational age between 24 and 30 weeks. Eligible infants will be randomized to stabilization with an initial FiO2 of either 1.0 or 0.3 at birth. Hereafter, FiO2 will be titrated based on the oxygen saturation target range. In both groups, all other interventions during stabilization and thereafter will be similar. The primary outcome is respiratory effort in the first 5 min after birth expressed as average minute volume/kg. Secondary outcomes include inspired tidal volumes/kg, rate of rise to maximum tidal volume/kg, percentage of recruitment breaths with tidal volumes above 8 mL/kg, duration of hypoxia and hyperoxia and plasma levels of markers of oxidative stress (8-iso-prostaglandin F2α).Discussion: Current resuscitation guidelines recommend oxygen titration if infants fail to achieve the 25th percentile of the SpO2 reference ranges. It has become clear that, using this approach, most preterm infants are at risk for hypoxia in the first 5 min after birth, which could suppress the breathing effort. In addition, for compromised preterm infants who need respiratory support at birth, higher SpO2 reference ranges in the first minutes after birth might be needed to prevent prolonged hypoxia. Enhancing breathing effort by achieving an adequate level of oxygenation could potentially lead to a lower incidence of intubation and mechanical ventilation in the delivery room, contributing to a lower risk on lung injury in high-risk preterm infants. Measuring 8-iso-prostaglandin F2α could lead to a reflection of the true amount of oxygen exposure in both study groups.

Objective This study aims to evaluate the performance of the fabian-Predictive-Intelligent-Control-of-Oxygenation (PRICO) system for automated control of the fraction of inspired oxygen (FiO2).Design Multicentre randomised cross-over study.Setting Five neonatal intensive care units experienced with automated control of FiO2 and the fabian ventilator.Patients 39 infants: median gestational age of 27 weeks (IQR: 26–30), postnatal age 7 days (IQR: 2–17), weight 1120 g (IQR: 915–1588), FiO2 0.32 (IQR: 0.22–0.43) receiving both non-invasive (27) and invasive (12) respiratory support.Intervention Randomised sequential 24-hour periods of automated and manual FiO2 control.Main outcome measures Proportion (%) of time in normoxaemia (90%–95% with FiO2>0.21 and 90%–100% when FiO2=0.21) was the primary endpoint. Secondary endpoints were severe hypoxaemia (98% with FiO2>0.21) and prevalence of episodes ≥60 s at these two SpO2 extremes.Results During automated control, subjects spent more time in normoxaemia (74%±22% vs 51%±22%, p95% with FiO2>0.21 (16%±19% vs 35%±24%) p