A pilot study of evaluation of semi-rigid and flexible catheters for less invasive surfactant administration in preterm infants with respiratory distress syndrome—a randomized controlled trial

Abstract

Background In respiratory distress syndrome, many neonatology centers worldwide perform minimal invasive surfactant application in premature infants, using small-diameter catheters for endotracheal intubation and surfactant administration. Methods In this single-center, open-label, randomized-controlled trial, preterm infants requiring surfactant administration after birth, using a standardized minimal invasive protocol, were randomized to two different modes of endotracheal catheterization: Flexible charrière-4 feeding tube inserted using Magill forceps (group 1) and semi-rigid catheter (group 2). Primary outcome was duration of laryngoscopy. Secondary outcomes were complication rate (intraventricular hemorrhage, soft-tissue damage in first week of life) and vital parameters during laryngoscopy. Between 2019 and 2020, 31 infants were included in the study. Prior to in-vivo testing, laryngoscopy durations were studied on a neonatal airway mannequin in students, nurses and doctors. Results Mean gestational age and birth weight were 27 + 6/7 weeks and 1009 g; and 28 + 0/7 weeks and 1127 g for group 1 and 2, respectively. Length of laryngoscopy was similar in both groups (61.1 s and 64.9 s) overall (p.77) and adjusted for weight (p.70) or gestational age (p.95). Laryngoscopy failed seven times in group 1 (43.8%) and four times (26.7%) in group 2 (p.46). Longer laryngoscopy was associated with lower oxygen saturation with lowest levels occurring after failed laryngoscopy attempts. Secondary outcomes were similar in both groups. In vitro data on 40 students, 40 nurses and 12 neonatologists showed significant faster laryngoscopy in students and nurses group 2 (p < .0001) unlike in neonatologists (p.13). Conclusion This study showed no difference in laryngoscopy duration in endotracheal catheterization when comparing semi-rigid and flexible catheters for minimal invasive surfactant application in preterm infants. In accordance with preliminary data and in contrast to published in-vitro trials, experienced neonatologists were able to perform endotracheal catheterization using both semi-rigid and flexible catheters at similar rates and ease, in vitro and in vivo. Trial registration ClinicalTrials.gov. NCT05024435 Registered 27 August 2021—Retrospectively registered.

Prevention of Chronic Morbidities in Extremely Premature Newborns with LISA-nCPAP Respiratory Therapy and Adjuvant Perinatal Strategies

“…Since its first description, various flexible and semi-rigid catheter techniques have been reported for LISA [ 20 , 23 ], and the preferred choice of equipment shows significant differences worldwide [ 24 , 25 , 26 , 27 , 28 , 29 ]. According to clinical trials [ 30 , 31 ] and in contrast with simulation studies [ 32 , 33 ], experienced neonatologists are able to perform endotracheal catheterization using both semi-rigid and flexible catheters at similar rates and ease.…”

“…Since its first description, various flexible and semi-rigid catheter techniques have been reported for LISA [20,23], and the preferred choice of equipment shows significant differences worldwide [24][25][26][27][28][29]. According to clinical trials [30,31] and in contrast with simulation studies [32,33], experienced neonatologists are able to perform endotracheal catheterization using both semi-rigid and flexible catheters at similar rates and ease. Table 1 presents the results of LISA-related RCTs [34][35][36][37][38][39][40][41][42][43][44][45][46][47][48][49][50][51][52], while Table 2 summarises meta-analyses comparing LISA with surfactant administration via an endotracheal tube (S-ETT), with or without extubation (INSURE or infants remained intubated after surfactant delivery) [10,[53][54][55][56][57].…”

“…As for the hemodynamic effects of NIV, a study in 20 relatively stable preterm infants with a mean gestational age of 27 (25)(26)(27)(28)(29)(30)(31)(32) weeks compares right and left ventricular output and anterior cerebral blood flow velocity between nCPAP and non-synchronized NIV at a median postnatal age of 20 (9-28) days [109]. Switching between the two modalities has no discernible impact on the hemodynamic parameters assessed.…”