A Randomized Trial of Conditioned or Unconditioned Gases for Stabilizing Preterm Infants at Birth.

OBJECTIVE: To determine whether the use of heated-humidified gases for respiratory support during the stabilization of infants <30 weeks of gestational age (GA) in the delivery room reduces rates of hypothermia on admission to the neonatal intensive care unit (NICU). STUDY DESIGN: A multicenter, unblinded, randomized trial was conducted in Melbourne, Australia, between February 2013 and June 2015. Infants <30 weeks of GA were randomly assigned to receive either heated-humidified gases or unconditioned gases during stabilization in the delivery room and during transport to NICU. Infants born to mothers with pyrexia >38°C were excluded. Primary outcome was rate of hypothermia on NICU admission (rectal temperature <36.5°C). RESULTS: A total of 273 infants were enrolled. Fewer infants in the heated-humidified group were hypothermic on admission to NICU (36/132 [27%]) compared with controls (61/141 [43%], P < .01). There was no difference in rates of hyperthermia (>37.5°C); 20% (27/132) in the heated-humidified group compared with 16% (22/141) in the controls (P = .30). There were no differences in mortality or respiratory outcomes. CONCLUSIONS: The use of heated-humidified gases in the delivery room significantly reduces hypothermia on admission to NICU in preterm infants, without increased risk of hyperthermia. CLINICAL TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Register (www.anzctr.org.au) ACTRN12613000093785.

Inflammation, lipids and aortic intima-media thickness in newborns following chorioamnionitis.

AIM: This study investigated whether chorioamnionitis was associated with increased inflammation, dyslipidaemia and adverse cardiovascular phenotypes in the immediate postnatal period. METHODS: This prospective case-control study included preterm infants (30(+0) -35(+6) weeks gestational age, GA) whose mothers did not have pregnancy-related conditions that may influence outcomes. Chorioamnionitis was diagnosed by placental histology, and infants were divided retrospectively into cases (chorioamnionitis-exposed) and controls (unexposed). Serum high-sensitivity C-reactive protein (hsCRP), lipid profile, far-wall abdominal aortic intima-media thickness (aIMT) and blood pressure (BP) were measured in the first week of life. RESULTS: There were 20 (16 male, mean GA 32.4 weeks) cases and 31 (12 male, mean GA 32.6 weeks) controls. Histological chorioamnionitis was associated with a significant increase in hsCRP and a non-significant trend towards an adverse lipid profile. There was no evidence of differences in aIMT or BP. CONCLUSION: Preterm infants exposed to chorioamnionitis have greater postnatal inflammation. There were no early postnatal differences in aIMT or BP. The inflammatory stimulus of chorioamnionitis late in gestation may be of insufficient intensity and duration to result in immediate postnatal alterations to arterial structure. Cardiovascular follow-up of infants exposed to chorioamnionitis may identify differential risk trajectories and subsequent inflammatory responses.

Observational study of parental opinion of deferred consent for neonatal research.

OBJECTIVE: To evaluate the opinions of parents of newborns following their infant's enrolment into a neonatal research study through the process of deferred consent. DESIGN: Mixed-methods, observational study, interviewing 100 parents recently approached for deferred consent. SETTING: Tertiary-level neonatal intensive care unit, Melbourne, Australia. RESULTS: All 100 parents interviewed had consented to the study/studies using deferred consent; 62% had also experienced a prospective neonatal consent process. Eighty-nine per cent were 'satisfied' with the deferred consent process. The most common reason given for consenting was 'to help future babies'. Negative comments regarding deferred consent mostly related to the timing of the consent approach, and some related to a perceived loss of parental rights. A deferred approach was preferred by 51%, 24% preferred a prospective approach and 25% were unsure. Those who thought prospective consent would not have been preferable cited impaired decision-making, inappropriate timing of an approach before birth and their preference for removal of the decision-making burden via deferred consent. Seventy-seven per cent thought they would have given the same response if approached prospectively; those who would have declined reported that a prospective approach under stressful conditions was unwelcome and too overwhelming. CONCLUSION: In our sample, 89% of parents of infants enrolled in neonatal research using deferred consent considered it acceptable and half would not have preferred prospective consent. The ability to make a more considered decision under less stressful circumstances was key to the acceptability of deferred consent.

A randomized trial of oropharyngeal airways to assist stabilization of preterm infants in the delivery room.

OBJECTIVE: Positive pressure ventilation (PPV) using a ventilation device and a face mask is recommended for compromised newborn infants in the delivery room (DR). Airway obstruction and face mask leak during PPV may contribute to failure of resuscitation. Using an oropharyngeal airway (OPA) may improve efficacy of mask PPV. To determine whether the use of an OPA with mask PPV in the DR during stabilization of infants <34 weeks' gestational age, reduces the incidence of airway obstruction. INTERVENTION AND MEASUREMENTS: An international two center unblinded randomized trial. Infants assessed by the clinical team to require PPV, were randomly assigned to receive PPV using a T Piece device with either a soft round face mask alone or in combination with an appropriately sized OPA. Resuscitation protocols were standardized. A hot-wire anemometer flow sensor measured respiratory function during the first five minutes of stabilization. The primary outcome was the incidence of airway obstruction, either complete (no gas flow) or partial (minimal gas flows resulting in expired tidal volumes <2 mL/kg). MAIN RESULTS: A total of 137 infants were enrolled. Obstructed inflations were more frequently observed in infants stabilized with an OPA (81% vs. 64%; p = 0.03). Partial obstruction was more common in infants stabilized with an OPA (70% vs 54%; p = 0.04). There were no differences in mortality or respiratory outcomes for the whole cohort or in gestational age subgroups. CONCLUSIONS: Airway obstruction is common in preterm infants receiving mask ventilation in the DR. Using an oropharyngeal airway significantly increases the incidence of airway obstruction. REGISTERED CLINICAL TRIAL: Australian and New Zealand Clinical Trials Register; ACTRN 12612000392864.

Smaller facemasks for positive pressure ventilation in preterm infants: A randomised trial.

AIM: Facial measurements of preterm infants indicate that standard diameter facemasks used during positive pressure ventilation are too large, which may lead to mask leak and compromise resuscitation. We aimed to determine whether the use of a facemask that better complies with the dimensions of preterm faces, compared with a standard facemask, reduces facemask leak. METHODS: Parallel group, randomised controlled trial. Preterm infants ≤32 weeks' gestation receiving facemask ventilation prior to intubation in the neonatal intensive care unit, and those 28-32+6 weeks' receiving facemask ventilation in the delivery room were eligible. Infants were randomised to receive ventilation via a standard (50mm) (control), or a smaller (35mm or 42mm) diameter facemask (intervention), stratified by gestation (≤26 weeks'; 35mm, 27-32+6; 42mm). The primary outcome was leak between the mask and the infants face. RESULTS: Of 298 eligible infants, 139 were randomised and 131 were included in the final analysis; 66 in the intervention group and 65 in the control group. The median (IQR) leak was 42% (13-69%) in the intervention group compared with 39% (22-66%) in the control group P=0.43. The median (IQR) lowest oxygen saturation was similar in both groups [intervention 70% (34-93%) vs. control 71% (40-93%) P=0.75]. One infant crossed over from the intervention to the control group due to poor response to ventilation with the intervention facemask. CONCLUSIONS: Smaller facemasks did not reduce mask leak in preterm facemask ventilation. All facemasks had high leak, particularly in infants ≤26 weeks' gestation. CLINICAL TRIAL REGISTRATION: This trial is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12614000709640, www.anzctr.org.au.

A new suction mask to reduce leak during neonatal resuscitation: a manikin study.

OBJECTIVE: Leak around the face mask is a common problem during neonatal resuscitation. A newly designed face mask using a suction system to enhance contact between the mask and the infant's face might reduce leak and improve neonatal resuscitation. The aim of the study is to determine whether leak is reduced using the suction mask (Resusi-sure mask) compared with a conventional mask (Laerdal Silicone mask) in a manikin model. METHODS: Sixty participants from different professional categories (neonatal consultants, fellows, registrars, nurses, midwives and students) used each face mask in a random order to deliver 2 min of positive pressure ventilation to a manikin. Delivered airway pressures were measured using a pressure line. Inspiratory and expiratory flows were measured using a flow sensor, and expiratory tidal volumes and mask leaks were derived from these values. RESULTS: A median (IQR) leak of 12.1 (0.6-39.0)% was found with the conventional mask compared with 0.7 (0.2-4.6)% using the suction mask (p=0.002). 50% of the participants preferred to use the suction mask and 38% preferred to use the conventional mask. There was no correlation between leak and operator experience. CONCLUSIONS: A new neonatal face mask based on the suction system reduced leak in a manikin model. Clinical studies to test the safety and effectiveness of this mask are needed.

Videolaryngoscopy to Teach Neonatal Intubation: A Randomized Trial.

BACKGROUND: Neonatal endotracheal intubation is a necessary skill. However, success rates among junior doctors have fallen to <50%, largely owing to declining opportunities to intubate. Videolaryngoscopy allows instructor and trainee to share the view of the pharynx. We compared intubations guided by an instructor watching a videolaryngoscope screen with the traditional method where the instructor does not have this view. METHODS: A randomized, controlled trial at a tertiary neonatal center recruited newborns from February 2013 to May 2014. Eligible intubations were performed orally on infants without facial or airway anomalies, in the delivery room or neonatal intensive care, by doctors with <6 months' tertiary neonatal experience. Intubations were randomized to having the videolaryngoscope screen visible to the instructor or covered (control). The primary outcome was first-attempt intubation success rate confirmed by colorimetric detection of expired carbon dioxide. RESULTS: Two hundred six first-attempt intubations were analyzed. Median (interquartile range) infant gestation was 29 (27 to 32) weeks, and weight was 1142 (816 to 1750) g. The success rate when the instructor was able to view the videolaryngoscope screen was 66% (69/104) compared with 41% (42/102) when the screen was covered (P < .001, OR 2.81, 95% CI 1.54 to 5.17). When premedication was used, the success rate in the intervention group was 72% (56/78) compared with 44% (35/79) in the control group (P < .001, OR 3.2, 95% CI 1.6 to 6.6). CONCLUSIONS: Intubation success rates of inexperienced neonatal trainees significantly improved when the instructor was able to share their view on a videolaryngoscope screen.

Treatment of retinopathy of prematurity in Northern Ireland, 2000-2011: a population-based study.

PURPOSE: To evaluate the incidence of treatment-requiring retinopathy of prematurity (ROP) over a 12-year-period in Northern Ireland. METHODS: The medical records of all infants treated for ROP from January 2000 to December 2011 were retrospectively reviewed and cross-referenced with the Neonatal Intensive Care Outcomes Research and Evaluation (NICORE) database. RESULTS: The Northern Ireland population data showed an increase in the number of live births from 2000 to 2011. The proportion of babies born with a birth weight <1501 g and/or <32 weeks' gestational age remained constant (χ(2) trend = 3.220, P = 0.0727), although the proportion of these babies who died prior to 42 weeks' gestation decreased from 2000 to 2011 (P = 0.0196 using χ(2) for trend = 5.445; P = 0.0354 using χ(2) = 20.809). The prevalence of treatment-requiring ROP in these infants increased from 1.05% in 2000 to 5.78% in 2011 (P < 0.001 using χ(2) trend = 16.309; P < 0.001 using χ(2) = 31.378). CONCLUSIONS: The present population-based study highlights that the incidence of treatment- requiring ROP is increasing in Northern Ireland. The increasing number of infants requiring treatment will need to be taken into consideration in the commissioning process for ROP services in Northern Ireland.

Feasibility and practical considerations for heating and humidifying gases during newborn stabilisation: an in vitro model.

BACKGROUND: Gases for respiratory support at birth are typically 'cold and dry', which may increase the risk of hypothermia and lung injury. OBJECTIVES: To determine the feasibility of using heated humidification from birth. METHOD: A humidifier targeting 37°C, a manual-fill chamber and a Neopuff Infant T-piece resuscitator and circuit were attached to a face mask and a manikin. Recordings using 20 ml H2O for humidification and a flow of 10 l/min were undertaken. Temperature and relative humidity (RH) were recorded. Additional recordings were made, each with one alteration to baseline (50 ml H2O for humidification, auto-fill chamber, a flow of 8 l/min, addition of circuit extension piece, warmed humidification H2O, increased ambient temperature and targeting 31°C). The duration of heated humidification and the response to disconnecting the power were investigated. RESULTS: The baseline circuit achieved 95% RH and 31°C in 3 min, >99% RH in 7 min and ≥35°C in 9 min. No circuit alterations resulted in faster gas conditioning. The extended length circuit and targeting 31°C reduced the maximum temperature achieved. A flow of 8 l/min resulted in slower heating and humidification. The baseline circuit delivered heated humidification for 39 min. Without power, the temperature and humidity fell below international standards in 3 min. CONCLUSION: Rapid gas conditioning for newborn stabilisation is feasible using the experimental set-up, ≥20 ml H2O and a flow of 10 l/min. The circuit could be used immediately once switched on. Without power, conditioning is quickly lost. Investigation of the clinical effects of gas conditioning is warranted.