PENGUIN VS CATHETER FOR AIRWAY SUCTIONING AT BIRTH: A RANDOMIZED CONTROLLED TRIAL IN A LOW RESOURCE SETTING

Background: evidence from literature showed that suctioning should be offered only to newborn infants who have obvious obstruction to spontaneous breathing or who require positive pressure ventilation. International guidelines recommend the use of a penguin suction device or a suction catheter in newborn infants needing suctioning at birth, but literature does not provide any information on clinical differences between the two procedures. Objectives: this trial aims to compare two different methods of oropharyngeal suctioning (with penguin suction device or suction catheter) in newborn infants needing suctioning at birth. The primary outcome measure is oxygen saturation during the first 10 minutes of life. Setting: the study was conducted at the St. Luke Catholic Hospital in Wolisso (Ethiopia), which is a level III hospital with around 3,600 deliveries per year. This is a referral, private, nonprofit hospital located in Wolisso town, which is the capital of the Southwest Shoa Zone in the Oromiya region. Material and methods: this is a single center, prospective, randomized clinical trial comparing two different methods of oropharyngeal suctioning (with bulb syringe or suction catheter) in newborn infants needing suctioning at birth. 61 neonates, term and preterm, is enrolled in this study. Immediately after birth, all infants needing suctioning will be randomized to receive suctioning with bulb syringe or suction catheter. All resuscitative procedures will be performed following the Help Babies Breathe algorithm. An external observer, not involved in the care of the newborn, will be responsible of the positioning the probe of the pulse oximeter and the collection of the data. Results: 61 participants were enrolled in the trial (31 in electrical arm and 30 manual arm). The oxygen saturation increases over time in both arms (p < 0.0001), with the same slope (p = 0.7728). The heart rate increases over time in both arms (p < 0.0001), with no different slope (p = 0.9089). Admission to special care unit is more frequent in electrical vs. manual arm (61% vs. 33%, p = 0.0288). Conclusions: oxygen saturation and heart rate during the first ten minutes of life were the same when using a penguin suction device or a suction catheter. There were no differences between the two arms regarding the study secondary outcomes, except for the admission to the special care unit (NICU) which was significantly higher in the suction catheter group. Trial Registration: the study has been registered in ClinicalTrials.gov with identifier: NCT05472155.