Aim The aim of this study was to assess the resuscitators' opinions of the usefulness and clinical value of using a respiratory function monitor (RFM) when resuscitating extremely preterm infants... Show moreAim The aim of this study was to assess the resuscitators' opinions of the usefulness and clinical value of using a respiratory function monitor (RFM) when resuscitating extremely preterm infants with positive pressure ventilation. Methods The link to an online survey was sent to 106 resuscitators from six countries who were involved in a multicentre trial that compared the percentage of inflations within a predefined target range with and without the RFM. The resuscitators were asked to assess the usefulness and clinical value of the RFM. The survey was online for 4 months after the trial ended in May 2019. Results The survey was completed by 74 (70%) resuscitators of which 99% considered the RFM to be helpful during neonatal resuscitation and 92% indicated that it influenced their decision-making. The majority (76%) indicated that using the RFM improved their practice and made resuscitation more effective, even when the RFM was not available. Inadequate training was the key issue that limited the effectiveness of the RFM: 45% felt insufficiently trained, and 78% felt more training in using and interpreting the RFM would have been beneficial. Conclusion Resuscitators considered the RFM to be helpful to guide neonatal resuscitation, but sufficient training was required to achieve the maximum benefit. Show less
Objective To characterize respiratory function monitor (RFM) measurements of sustained inflations and intermittent positive pressure ventilation (IPPV) delivered non invasively to infants in the... Show moreObjective To characterize respiratory function monitor (RFM) measurements of sustained inflations and intermittent positive pressure ventilation (IPPV) delivered non invasively to infants in the Sustained Aeration of Infant Lungs (SAIL) trial and to compare vital sign measurements between treatment arms.Study design We analyzed RFM data from SAIL participants at 5 trial sites. We assessed tidal volumes, rates of airway obstruction, and mask leak among infants allocated to sustained inflations and IPPV, and we compared pulse rate and oxygen saturation measurements between treatment groups.Results Among 70 SAIL participants (36 sustained inflations, 34 IPPV) with RFM measurements, 40 (57%) were spontaneously breathing prior to the randomized intervention. The median expiratory tidal volume of sustained inflations administered was 5.3 mUkg (IQR 1.1-9.2). Significant mask leak occurred in 15% and airway obstruction occurred during 17% of sustained inflations. Among 34 control infants, the median expiratory tidal volume of IPPV inflations was 4.3 mUkg (IQR 1.3-6.6). Mask leak was present in 3%, and airway obstruction was present in 17% of IPPV inflations. There were no significant differences in pulse rate or oxygen saturation measurements between groups at any point during resuscitation.Conclusion Expiratory tidal volumes of sustained inflations and IPPV inflations administered in the SAIL trial were highly variable in both treatment arms. Vital sign values were similar between groups throughout resuscitation. Sustained inflation as operationalized in the SAIL trial was not superior to IPPV to promote lung aeration after birth in this study subgroup. Show less
Most preterm infants breathe at birth, but need additional respiratory support due to immaturity of the lung and respiratory control mechanisms. To avoid lung injury, the focus of respiratory... Show moreMost preterm infants breathe at birth, but need additional respiratory support due to immaturity of the lung and respiratory control mechanisms. To avoid lung injury, the focus of respiratory support has shifted from invasive towards non-invasive ventilation. However, applying effective non-invasive ventilation is difficult due to mask leak and airway obstruction. The larynx has been overlooked as one of the causes for obstruction, preventing face mask ventilation from inflating the lung. The larynx remains mostly closed at birth, only opening briefly during a spontaneous breath. Stimulating and supporting spontaneous breathing could enhance the success of non-invasive ventilation by ensuring that the larynx remains open. Maintaining adequate spontaneous breathing and thereby reducing the need for invasive ventilation is not only important directly after birth, but also in the first hours after admission to the NICU. Respiratory distress syndrome is an important cause of respiratory failure. Traditionally, treatment of RDS required intubation and mechanical ventilation to administer exogenous surfactant. However, new ways have been implemented to administer surfactant and preserve spontaneous breathing while maintaining non-invasive support. In this narrative review we aim to describe interventions focused on stimulation and maintenance of spontaneous breathing of preterm infants in the first hours after birth. Show less
Aim: To determine whether the use of a respiratory function monitor (RFM) during PPV of extremely preterm infants at birth, compared with no RFM, leads to an increase in percentage of inflations... Show moreAim: To determine whether the use of a respiratory function monitor (RFM) during PPV of extremely preterm infants at birth, compared with no RFM, leads to an increase in percentage of inflations with an expiratory tidal volume (Vte) within a predefined target range.Methods: Unmasked, randomised clinical trial conducted October 2013 - May 2019 in 7 neonatal intensive care units in 6 countries. Very preterm infants (24-27 weeks of gestation) receiving PPV at birth were randomised to have a RFM screen visible or not. The primary outcome was the median proportion of inflations during manual PPV (face mask or intubated) within the target range (Vte 4-8 mL/kg). There were 42 other prespecified monitor measurements and clinical outcomes.Results: Among 288 infants randomised (median (IQR) gestational age 26(+2) (25(+3)-27(+1)) weeks), a total number of 51,352 inflations were analysed. The median (IQR) percentage of inflations within the target range in the RFM visible group was 30.0 (18.0-42.2)% vs 30.2 (14.8-43.1)% in the RFM non-visible group (p = 0.721). There were no dierences in other respiratory function measurements, oxygen saturation, heart rate or FiO(2). There were no dierences in clinical outcomes, except for the incidence of intraventricular haemorrhage (all grades) and/or cystic periventricular leukomalacia (visible RFM: 26.7% vs non-visible RFM: 39.0%; RR 0.71 (0.68-0.97); p = 0.028).Conclusion: In very preterm infants receiving PPV at birth, the use of a RFM, compared to no RFM as guidance for tidal volume delivery, did not increase the percentage of inflations in a predefined target range. Show less
Pas, A. te; Roehr, C.C.; Foglia, E.E.; Hooper, S. 2021
Background A respiratory function monitor (RFM) provides real-time positive pressure ventilation feedback. Whether providers use RFM during neonatal resuscitation is unknown.Methods Ancillary study... Show moreBackground A respiratory function monitor (RFM) provides real-time positive pressure ventilation feedback. Whether providers use RFM during neonatal resuscitation is unknown.Methods Ancillary study to the MONITOR (NCT03256578) randomised controlled trial. Neonatal resuscitation leaders at two centres wore eye-tracking glasses, and visual attention (VA) patterns were compared between RFM-visible and RFM-masked groups.Results 14 resuscitations (6 RFM-visible, 8 RFM-masked) were analysed. The median total gaze duration on the RFM was significantly higher with a visible RFM (29% vs 1%, p<0.01), while median total gaze duration on other physical objects was significantly lower with a visible RFM (3% vs 8%, p=0.02). Median total gaze duration on the infant was lower with RFM visible, although not statistically significantly (29% vs 46%, p=0.05).Conclusion Providers' VA patterns differed during neonatal resuscitation when the RFM was visible, emphasising the importance of studying the impact of additional delivery room technology on providers' behaviour. Show less
Yang, K.C.; Pas, A.B.T.; Weinberg, D.D.; Foglia, E.E. 2020
Objective The clinical impact of ventilation corrective steps for delivery room positive pressure ventilation (PPV) is not well studied. We aimed to characterise the performance and effect of... Show moreObjective The clinical impact of ventilation corrective steps for delivery room positive pressure ventilation (PPV) is not well studied. We aimed to characterise the performance and effect of ventilation corrective steps (MRSOPA (Mask adjustment, Reposition airway, Suction mouth and nose, Open mouth, Pressure increase and Alternative airway)) during delivery room resuscitation of preterm infants.Design Prospective observational study of delivery room PPV using video and respiratory function monitor recordings.Setting Tertiary academic delivery hospital.Patients Preterm infants <32 weeks gestation.Main outcome measure Mean exhaled tidal volume (Vte) of PPV inflations before and after MRSOPA interventions, categorised as inadequate (<4 mL/kg); appropriate (4-8 mL/kg), or excessive (>8 mL/kg). Secondary outcomes were leak (>30%) and obstruction (Vte <1 mL/kg), and infant heart rate.Results There were 41 corrective interventions in 30 infants, with a median duration of 15 (IQR 7-29) s. The most frequent intervention was a combination of Mask/Reposition and Suction/Open. Mean Vte was inadequate before 16/41 interventions and became adequate following 6/16. Mean Vte became excessive after 6/41 interventions. Mask leak, present before 13/41 interventions, was unchanged after 4 and resolved after 9. Obstruction was present before five interventions and was subsequently resolved only once. MRSOPA interventions introduced leak in two cases and led to obstruction in one case. The heart rate was <100 beats per minute before 31 interventions and rose to >100 beats per minute after 14/31 of these.Conclusions Ventilation correction interventions improve tidal volume delivery in some cases, but lead to ineffective or excessive tidal volumes in others. Mask leak and obstruction can be induced by MRSOPA manoeuvres. Show less
Boer, M.C. den; Houtlosser, M.; Foglia, E.E.; Lopriore, E.; Vries, M.C. de; Engberts, D.P.; Pas, A.B. te 2020
Objective To gain insight into neonatal care providers' perceptions of deferred consent for delivery room (DR) studies in actual scenarios.Methods We conducted semistructured interviews with 46... Show moreObjective To gain insight into neonatal care providers' perceptions of deferred consent for delivery room (DR) studies in actual scenarios.Methods We conducted semistructured interviews with 46 neonatal intensive care unit (NICU) staff members of the Leiden University Medical Center (the Netherlands) and the Hospital of the University of Pennsylvania (USA). At the time interviews were conducted, both NICUs conducted the same DR studies, but differed in their consent approaches. Interviews were audio-recorded, transcribed and analysed using the qualitative data analysis software Atlas.ti V.7.0.Results Although providers reported to regard the prospective consent approach as the most preferable consent approach, they acknowledged that a deferred consent approach is needed for high-quality DR management. However, providers reported concerns about parental autonomy, approaching parents for consent and ethical review of study protocols that include a deferred consent approach. Providers furthermore differed in perceived appropriateness of a deferred consent approach for the studies that were being conducted at their NICUs. Providers with first-hand experience with deferred consent reported positive experiences that they attributed to appropriate communication and timing of approaching parents for consent.Conclusion Insight into providers' perceptions of deferred consent for DR studies in actual scenarios suggests that a deferred consent approach is considered acceptable, but that actual usage of the approach for DR studies can be improved on. Show less
IMPORTANCE Most preterm infants require respiratory support to establish lung aeration after birth. Intermittent positive pressure ventilation and continuous positive airway pressure are standard... Show moreIMPORTANCE Most preterm infants require respiratory support to establish lung aeration after birth. Intermittent positive pressure ventilation and continuous positive airway pressure are standard therapies. An initial sustained inflation (inflation time >5 seconds) is a widely practiced alternative strategy.OBJECTIVE To conduct a systematic review and meta-analysis of sustained inflation vs intermittent positive pressure ventilation and continuous positive airway pressure for the prevention of hospital mortality and morbidity for preterm infants.DATA SOURCES MEDLINE (through PubMed), Embase, the Cumulative Index of Nursing and Allied Health Literature, and the Cochrane Central Register of Controlled Trials were searched through June 24, 2019.STUDY SELECTION Randomized clinical trials of preterm infants born at less than 37 weeks' gestation that compared sustained inflation (inflation time >5 seconds) vs standard resuscitation with either intermittent positive pressure ventilation or continuous positive airway pressure were included. Studies including other cointerventions were excluded.DATA EXTRACTION AND SYNTHESIS Two reviewers assessed the risk of bias of included studies. Meta-analysis of pooled outcome data used a fixed-effects model specific to rarer events. Subgroups were based on gestational age and study design (rescue vs prophylactic sustained inflation).MAIN OUTCOMES AND MEASURES Death before hospital discharge.RESULTS Nine studies recruiting 1406 infants met inclusion criteria. Death before hospital discharge occurred in 85 of 736 infants (11.5%) treated with sustained inflation and 62 of 670 infants (9.3%) who received standard therapy for a risk difference of 3.6%(95% CI, -0.7% to 7.9%). Although analysis of the primary outcome identified important heterogeneity based on gestational age subgroups, the 95% CI for the risk difference included 0 for each individual gestational age subgroup. There was no difference in the primary outcome between subgroups based on study design. Sustained inflation was associated with increased risk of death in the first 2 days after birth (risk difference, 3.1%; 95% CI, 0.9%-5.3%). No differences in the risk of other secondary outcomes were identified. The quality-of-evidence assessment was low owing to risk of bias and imprecision.CONCLUSIONS AND RELEVANCE There was no difference in the risk of the primary outcome of death before hospital discharge, and there was no evidence of efficacy for sustained inflation to prevent secondary outcomes. These findings do not support the routine use of sustained inflation for preterm infants after birth. Show less
Boer, M.C. den; Houtlosser, M.; Foglia, E.E.; Tan, R.N.G.B.; Engberts, D.P.; Pas, A.B. te 2019
Objective To assess benefits of recording and reviewing neonatal resuscitation as experienced by neonatal care providers. Design A qualitative study using semistructured interviews questioning... Show moreObjective To assess benefits of recording and reviewing neonatal resuscitation as experienced by neonatal care providers. Design A qualitative study using semistructured interviews questioning neonatal care providers about their experiences with recording and reviewing neonatal resuscitation. Data were analysed using the qualitative data analysis software Atlas.ti V.7.0. Setting Neonatal care providers working at neonatal intensive care units (NICUs) of the Leiden University Medical Center, the Netherlands, and the University of Pennsylvania School of Medicine, USA, participated in this study. Results In total, 48 NICU staff members were interviewed. Reported experiences and attitudes are broadly similar for both NICUs. All interviewed providers reported positive experiences and benefits, with special emphasis on educational benefits. Recording and reviewing neonatal resuscitation is used for various learning activities, such as plenary review meetings and as tool for objective feedback. Providers reported to learn from reviewing their own performance during resuscitation, as well as from reviewing performances of others. Improved time perception, reflection on guideline compliance and acting less invasively during resuscitations were often mentioned as learning outcomes. All providers would recommend other NICUs to implement recording and reviewing neonatal resuscitation, as it is a powerful tool for learning and improving. However, they emphasised preconditions for successful implementation, such as providing information, not being punitive and focusing on the benefits for learning and improving. Conclusion Recording and reviewing neonatal resuscitation is considered highly beneficial for learning and improving resuscitation skills and is recommended by providers participating in it. Show less
Boer, M.C. den; Houtlosser, M.; Foglia, E.E.; Davis, P.G.; Kaam, A.H. van; Kamlin, C.O.F.; ... ; Pas, A.B. te 2019
Background: Extremely preterm infants require assistance recruiting the lung to establish a functional residual capacity after birth. Sustained inflation (SI) combined with positive end expiratory... Show moreBackground: Extremely preterm infants require assistance recruiting the lung to establish a functional residual capacity after birth. Sustained inflation (SI) combined with positive end expiratory pressure (PEEP) may be a superior method of aerating the lung compared with intermittent positive pressure ventilation (IPPV) with PEEP in extremely preterm infants. The Sustained Aeration of Infant Lungs (SAIL) trial was designed to study this question.Methods/Design: This multisite prospective randomized controlled unblinded trial will recruit 600 infants of 23 to 26 weeks gestational age who require respiratory support at birth. Infants in both arms will be treated with PEEP 5 to 7 cm H2O throughout the resuscitation. The study intervention consists of performing an initial SI (20 cm H2O for 15 seconds) followed by a second SI (25 cm H2O for 15 seconds), and then PEEP with or without IPPV, as needed. The control group will be treated with initial IPPV with PEEP. The primary outcome is the combined endpoint of bronchopulmonary dysplasia or death at 36 weeks post-menstrual age. Show less
