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1.
N Engl J Med ; 2024 May 05.
Article in English | MEDLINE | ID: mdl-38709215

ABSTRACT

BACKGROUND: Repeated attempts at endotracheal intubation are associated with increased adverse events in neonates. When clinicians view the airway directly with a laryngoscope, fewer than half of first attempts are successful. The use of a video laryngoscope, which has a camera at the tip of the blade that displays a view of the airway on a screen, has been associated with a greater percentage of successful intubations on the first attempt than the use of direct laryngoscopy in adults and children. The effect of video laryngoscopy among neonates is uncertain. METHODS: In this single-center trial, we randomly assigned neonates of any gestational age who were undergoing intubation in the delivery room or neonatal intensive care unit (NICU) to the video-laryngoscopy group or the direct-laryngoscopy group. Randomization was stratified according to gestational age (<32 weeks or ≥32 weeks). The primary outcome was successful intubation on the first attempt, as determined by exhaled carbon dioxide detection. RESULTS: Data were analyzed for 214 of the 226 neonates who were enrolled in the trial, 63 (29%) of whom were intubated in the delivery room and 151 (71%) in the NICU. Successful intubation on the first attempt occurred in 79 of the 107 patients (74%; 95% confidence interval [CI], 66 to 82) in the video-laryngoscopy group and in 48 of the 107 patients (45%; 95% CI, 35 to 54) in the direct-laryngoscopy group (P<0.001). The median number of attempts to achieve successful intubation was 1 (95% CI, 1 to 1) in the video-laryngoscopy group and 2 (95% CI, 1 to 2) in the direct-laryngoscopy group. The median lowest oxygen saturation during intubation was 74% (95% CI, 65 to 78) in the video-laryngoscopy group and 68% (95% CI, 62 to 74) in the direct-laryngoscopy group; the lowest heart rate was 153 beats per minute (95% CI, 148 to 158) and 148 (95% CI, 140 to 156), respectively. CONCLUSIONS: Among neonates undergoing urgent endotracheal intubation, video laryngoscopy resulted in a greater number of successful intubations on the first attempt than direct laryngoscopy. (Funded by the National Maternity Hospital Foundation; VODE ClinicalTrials.gov number, NCT04994652.).

2.
Arch Dis Child Fetal Neonatal Ed ; 109(3): 317-321, 2024 Apr 18.
Article in English | MEDLINE | ID: mdl-38212105

ABSTRACT

OBJECTIVE: Hypothermia on admission to the neonatal intensive care unit (NICU) is associated with an increased risk of death in preterm infants. There are currently no evidence-based recommendations for thermal care before cord clamping (CC). We wished to determine whether placing very preterm infants in a polyethylene bag (PB) before CC, compared with after CC, results in more infants with a temperature in the normal range on NICU admission. DESIGN: Randomised controlled trial. SETTING: Tertiary maternity hospital. PATIENTS: Inborn infants<32 weeks' gestational age (GA). INTERVENTIONS: Infants were randomly assigned to have a PB placed before or after CC. MAIN OUTCOME: Rectal temperature within the normal range (36.5°C-37.5°C) on NICU admission. RESULTS: Between July 2020 and September 2022, 198/220 (90%) eligible infants were enrolled in this study; 99 (44 (44%) girls) were randomly assigned to BEFORE and 99 (53 (54%) girls) to AFTER. Median (IQR) GA 29 (27-31) vs 29 (27-31) weeks, mean (SD) birth weight 1206 (429) vs 1138 (419) g, respectively. The proportion of infants who had normal temperature on NICU admission did not differ between the groups (BEFORE 54/99 (55%) vs AFTER 55/98 (56%), p 0.824). The proportion of infants with a temperature outside of the normal range was similar between the groups; hypothermia (BEFORE 34/99 (34%) vs AFTER 33/98 (34%), hyperthermia (BEFORE 10/99 (10%) vs AFTER 10/98 (10%)). CONCLUSIONS: Placing a PB before CC did not increase the proportion of preterm infants with normal temperature on NICU admission. A large proportion of preterm infants had abnormal temperature. Further studies on thermoregulation before CC are needed. TRIAL REGISTRATION NUMBER: NCT04463511.


Subject(s)
Hypothermia , Infant, Premature, Diseases , Pregnancy , Infant, Newborn , Humans , Female , Male , Infant, Premature , Hypothermia/prevention & control , Hypothermia/etiology , Polyethylene , Constriction , Infant, Very Low Birth Weight , Intensive Care Units, Neonatal
3.
Article in English | MEDLINE | ID: mdl-38272657

ABSTRACT

OBJECTIVE: The International Liaison Committee on Resuscitation has recommended improvements in training for neonatal resuscitation, highlighting the potential role of respiratory function monitors (RFMs). Our objective was to determine whether a manikin-based, standardised face mask ventilation training intervention using an RFM with a simple visual display reduced face mask leak. DESIGN: Multicentre, before and after study. Participants and instructors were blinded to the RFM display during both assessment periods. PARTICIPANTS: Healthcare professionals working or training in a hospital providing maternity and neonatal services. INTERVENTION: All participants underwent a training intervention on positive pressure ventilation using a modified, leak-free manikin and RFM. The intervention consisted of a demonstration of optimal face mask ventilation technique, training in RFM interpretation with corrective strategies for common scenarios and a period of deliberate practice. Each participant performed 30 s of positive pressure ventilation blinded to the RFM display before and after training. MAIN OUTCOME MEASURES: The primary outcome was face mask leak (%) measured after training. Secondary outcome measures included expired tidal volume, inflating pressures and ventilation rate. Adjustments made to technique during training were an important qualitative outcome. RESULTS: Four hundred and fourteen participants were recruited over a 13-month period from April 2022, and 412 underwent analysis. Median (IQR) face mask leak before training was 31% (10-69%) compared with 10% (6-18%) after training (p<0.0001). Improvements were noted across all other ventilation parameters. CONCLUSION: Standardised face mask ventilation training using an RFM with simple visual feedback led to a significant reduction in leak.

4.
Cochrane Database Syst Rev ; 10: CD009102, 2023 10 03.
Article in English | MEDLINE | ID: mdl-37787113

ABSTRACT

BACKGROUND: The Neonatal Task Force of the International Liaison Committee on Resuscitation (ILCOR) makes practice recommendations for the care of newborn infants in the delivery room (DR). ILCOR recommends that all infants who are gasping, apnoeic, or bradycardic (heart rate < 100 per minute) should be given positive pressure ventilation (PPV) with a manual ventilation device (T-piece, self-inflating bag, or flow-inflating bag) via an interface. The most commonly used interface is a face mask that encircles the infant's nose and mouth. However, gas leak and airway obstruction are common during face mask PPV. Nasal interfaces (single and binasal prongs (long or short), or nasal masks) and laryngeal mask airways (LMAs) may also be used to deliver PPV to newborns in the DR, and may be more effective than face masks. OBJECTIVES: To determine whether newborn infants receiving PPV in the delivery room with a nasal interface compared to a face mask, laryngeal mask airway (LMA), or another type of nasal interface have reduced mortality and morbidity. To assess whether safety and efficacy of the nasal interface differs according to gestational age or ventilation device. SEARCH METHODS: Searches were conducted in September 2022 in CENTRAL, MEDLINE, Embase, Epistemonikos, and two trial registries. We searched conference abstracts and checked the reference lists of included trials and related systematic reviews identified through the search. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-RCT's that compared the use of nasal interfaces to other interfaces (face masks, LMAs, or one nasal interface to another) to deliver PPV to newborn infants in the DR. DATA COLLECTION AND ANALYSIS: Each review author independently evaluated the search results against the selection criteria, screened retrieved records, extracted data, and appraised the risk of bias. If they were study authors, they did not participate in the selection, risk of bias assessment, or data extraction related to the study. In such instances, the study was independently assessed by other review authors. We contacted trial investigators to obtain additional information. We completed data analysis according to the standards of Cochrane Neonatal, using risk ratio (RR) and 95% confidence Intervals (CI) to measure the effect of the different interfaces. We used fixed-effect models and the GRADE approach to assess the certainty of the evidence. MAIN RESULTS: We included five trials, in which 1406 infants participated. They were conducted in 13 neonatal centres across Europe and Australia. Each of these trials compared a nasal interface to a face mask for the delivery of respiratory support to newborn infants in the DR. Potential sources of bias were a lack of blinding to treatment allocation of the caregivers and investigators in all trials. The evidence suggests that resuscitation with a nasal interface in the DR, compared with a face mask, may have little to no effect on reducing death before discharge (typical risk ratio (RR) 0.72, 95% CI 0.47 to 1.13; 3 studies, 1124 infants; low-certainty evidence). Resuscitation with a nasal interface may reduce the rate of intubation in the DR, but the evidence is very uncertain (RR 0.68, 95% CI 0.54 to 0.85; 5 studies, 1406 infants; very low-certainty evidence). The evidence is very uncertain for the rate of intubation within 24 hours of birth (RR 0.97, 95% CI 0.85 to 1.09; 3 studies, 749 infants; very low-certainty evidence), endotracheal intubation outside the DR during hospitalisation (RR 1.15, 95% CI 0.93 to 1.42; 1 study, 144 infants; very low-certainty evidence) and cranial ultrasound abnormalities (intraventricular haemorrhage (IVH) grade ≥ 3, or periventricular leukomalacia; RR 0.94, 95% CI 0.55 to 1.61; 3 studies, 749 infants; very low-certainty evidence). Resuscitation with a nasal interface in the DR, compared with a face mask, may have little to no effect on the incidence of air leaks (RR 1.09, 95% CI 0.85 to 1.09; 2 studies, 507 infants; low-certainty evidence), or the need for supplemental oxygen at 36 weeks' corrected gestational age (RR 1.06, 95% CI 0.8 to 1.40; 2 studies, 507 infants; low-certainty evidence). We identified one ongoing study, which compares a nasal mask to a face mask to deliver PPV to infants in the DR. We did not identify any completed trials that compared nasal interfaces to LMAs or one nasal interface to another. AUTHORS' CONCLUSIONS: Nasal interfaces were found to offer comparable efficacy to face masks (low- to very low-certainty evidence), supporting resuscitation guidelines that state that nasal interfaces are a comparable alternative to face masks for providing respiratory support in the DR. Resuscitation with a nasal interface may reduce the rate of intubation in the DR when compared with a face mask. However, the evidence is very uncertain. This uncertainty is attributed to the use of a new ventilation system in the nasal interface group in two of the five trials. As such, it is not possible to differentiate separate, specific effects related to the ventilation device or to the interface in these studies.


Subject(s)
Positive-Pressure Respiration , Resuscitation , Infant, Newborn , Humans , Resuscitation/methods , Positive-Pressure Respiration/adverse effects , Positive-Pressure Respiration/methods , Respiration, Artificial , Intermittent Positive-Pressure Ventilation , Intubation, Intratracheal
5.
Arch Dis Child Fetal Neonatal Ed ; 108(3): 244-249, 2023 May.
Article in English | MEDLINE | ID: mdl-36307187

ABSTRACT

OBJECTIVE: In adult patients with acute respiratory failure, nasal high-flow (NHF) therapy at the time of intubation can decrease the duration of hypoxia. The objective of this pilot study was to calculate duration of peripheral oxygen saturation below 75% during single and multiple intubation attempts in order to inform development of a larger definitive trial. DESIGN AND SETTING: This double-blinded randomised controlled pilot trial was conducted at a single, tertiary neonatal centre from October 2020 to October 2021. PARTICIPANTS: Infants undergoing oral intubation in neonatal intensive care were included. Infants with upper airway anomalies were excluded. INTERVENTIONS: Infants were randomly assigned (1:1) to have NHF 6 L/min, FiO2 1.0 or NHF 0 L/min (control) applied during intubation, stratified by gestational age (<34 weeks vs ≥34 weeks). MAIN OUTCOME MEASURES: The primary outcome was duration of hypoxaemia of <75% up to the time of successful intubation, RESULTS: 43 infants were enrolled (26 <34 weeks and 17 ≥34 weeks) with 50 intubation episodes. In infants <34 weeks' gestation, median duration of SpO2 of <75% was 29 s (0-126 s) vs 43 s (0-132 s) (p=0.78, intervention vs control). Median duration of SpO2 of <75% in babies ≥34 weeks' gestation was 0 (0-32 s) vs 0 (0-20 s) (p=0.9, intervention vs control). CONCLUSION: This pilot study showed that it is feasible to provide NHF during intubation attempts. No significant differences were noted in duration of oxygen saturation of <75% between groups; however, this trial was not powered to detect a difference. A larger, higher-powered blinded study is warranted.


Subject(s)
Hypoxia , Intubation, Intratracheal , Infant, Newborn , Infant , Humans , Pilot Projects , Hypoxia/etiology , Hypoxia/therapy , Gestational Age , Nose , Oxygen , Oxygen Inhalation Therapy
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