Nasal midazolam vs ketamine for neonatal intubation in the delivery room: a randomised trial.

OBJECTIVE: To compare the effectiveness of sedation by intranasal administration of midazolam (nMDZ) or ketamine (nKTM) for neonatal intubation. DESIGN: A multicentre, prospective, randomised, double-blind study. SETTING: Delivery rooms at four tertiary perinatal centres in France. PATIENTS: Preterm neonates with respiratory distress requiring non-emergent endotracheal intubation for surfactant instillation. INTERVENTIONS: Treatment was randomly allocated, with each neonate receiving a bolus of 0.1 mL/kg in each nostril, corresponding to 0.2 mg/kg for nMDZ and 2 mg/kg for nKTM. The drug was repeated once 7 min later at the same dose if adequate sedation was not obtained. MAIN OUTCOME MEASURES: Success was defined by adequate sedation before intubation and adequate comfort during the procedure. Intubation features, respiratory and cardiovascular events were recorded. RESULTS: Sixty newborns, with mean (SD) gestational age and birth weight of 28 (3) weeks and 1100 (350) g, were included within the first 20 min of life. nMDZ was associated with a higher success rate (89% vs 58%; RR: 1.54, 95% CI 1.12 to 2.12, p<0.01) and shorter delays between the first dose and intubation (10 (6) vs 16 (8) min, p<0.01).Number of attempts, time to intubation, mean arterial blood pressure measures over the first 12 hours after birth and length of invasive ventilation were not different. CONCLUSIONS: nMDZ was more efficient than nKTM to adequately sedate neonates requiring intubation in the delivery room. The haemodynamic and respiratory effects of both drugs were comparable. CLINICAL TRIAL: This clinical trial was recorded on the National Library of Medicine registry (NCT01517828).

Perfusion index and its dynamic changes in preterm neonates with patent ductus arteriosus.

AIM: The perfusion index (PI) and its dynamic change during respiration, and supressed the plethysmographic variability index (PVI), are calculated from pulse oximetry, and these indexes were recently proposed for continuous and noninvasive assessment of peripheral perfusion in neonates. We aimed to assess the effect of patent ductus arteriosus (PDA) on PI and PVI, according to ductal Doppler flow pattern. METHODS: Forty-five neonates with median (Q25-75) gestational age (GA) and birthweight of 27 (25-28) weeks and 857 (750-1080) grams, respectively, were assessed prospectively using serial echocardiography and pulse oximetry during the first postnatal week. RESULTS: Perfusion index increased from 0.70 (0.50-1.05) at day 1 to 1.50 (1.0-2.00) at day 7 (p < 0.01) and was not influenced by ductal flow pattern. PVI was 22 (18-27) and did not vary during the study period but differed according to ductal flow pattern, with lower values in the growing and pulsatile groups compared with the pulmonary hypertension (p < 0.05), closing and closed groups (p < 0.01). CONCLUSIONS: Ductal persistence and flow pattern did not affect PI but did affect PVI in preterm neonates of less than 29 weeks of GA. Future studies are needed to establish the usefulness of PVI in the early detection and management of PDA in preterm neonates.

Continuous positive airway pressure ventilation with helmet in infants under 1 year.

OBJECTIVE: To report the feasibility of helmet use in infants between 1 and 12 months old with acute respiratory failure. DESIGN AND SETTING: Observations were made before and 2 h after helmet CPAP of 6 cm H(2)O. Failure was defined as recourse to intratracheal ventilation. Patient stabilization or improvement was defined as a variation <10% or a decrease >10% in one of the following: respiratory rate, inspired oxygen fraction, or capillary partial pressure of CO(2). Tolerance was assessed by the pain and discomfort score, the systematic search for pressure sores, and the measurement of helmet humidity and noise level. RESULTS: Twenty-three infants with a median age of 5 (2-8) months were included. Helmet CPAP failed in two (9%) patients. Stability or improvement occurred in 16 (70%) patients. The pain and discomfort score was stable or improved in 22 (96%). Pressure sores were found in three (13%) infants. Humidity was 98% (98-99%) and fell to 40% (39-43%) after the humidifier was stopped. The noise level in the helmet was 81 (77-94) dB-SPL. CONCLUSIONS: The helmet was a satisfactory interface for CPAP delivery in young infants in more than two-thirds of the cases. Pressure sores can be prevented by placing a cushion in the helmet. Caregivers need to take into account the high humidity and noise levels of this interface.

Validation of a neonatal pain scale adapted to the new practices in caring for preterm newborns.

UNLABELLED: BACKGROUND Neonatal pain assessment generally requires access to facial expression. Improved neonatology practices, such as greater protection against bright lights and non-invasive mask ventilation, have made facial observation more difficult. OBJECTIVE: To validate a 'faceless' acute neonatal pain scale (FANS), which does not depend on facial expression. METHODS: In a prospective, multicentre study, 24-40-week-old neonates were videotaped during a painful procedure (heel prick). Three investigators then scored the pain using FANS and a previously validated scale: DAN (Douleur aiguë du Nouveau-né). FANS is based on assessment of limb movement, cry and autonomic reaction. Reliability was assessed by inter-rater agreement and internal consistency (Cronbach's alpha). Validity was evaluated by agreement between scales (intraclass correlation coefficient (ICC)). The Wilcoxon test evaluated the FANS score differences between conditions. Results are expressed as medians (25th and 75th percentiles). Ranges are presented for outcome parameters. RESULTS: From April 2006 to September 2007, 53 preterms of 32 (30-35) gestational weeks and 1500 (1000-2200) g were observed. Cronbach's alpha was 0.72. The ICC was 0.92 (0.9-0.98) for inter-rater agreement and 0.88 (0.76-0.93) for agreement between scales. CONCLUSION: FANS, which is reliable and valid, is the first scale to score pain in preterm newborns when facial expression is not accessible.