A randomized controlled trial for neonatal suctioning in a low-resource setting delivery room: a comparison between penguin and catheter

ABSTRACT Background: evidence from literature showed that suctioning should be offered to newborn infants who have obvious obstruction to spontaneous breathing or who require positive pressure ventilation. In these cases, international guidelines recommend the use of a penguin suction device or a suction catheter in newborn infants needing suctioning at birth, but they do 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 was oxygen saturation during the first 10 minutes of life. Materials and methods: the study was conducted from August to October 2021 and from June to September 2022 at the St. Luke Catholic Hospital, Wolisso (Ethiopia), a non-profit, referral, private, level III hospital with around 3,600 deliveries per year. This was a single center, prospective, randomized clinical trial comparing two different methods of oropharyngeal suctioning (with bulb syringe/penguin or suction catheter). Sixty-one neonates, term and preterm, were enrolled. Inclusion criteria included neonates of any gestational age, need for oronasopharyngeal suctioning and parental consent. Immediately after birth, all infants needing suctioning were randomized to receive suctioning with bulb syringe/penguin or suction catheter. All resuscitative procedures were performed following the Help Babies Breathe algorithm. An external observer, not involved in the care of the newborn, was responsible of the positioning of the pulse oximeter probe and the data collection, first among all oxygen saturation and heart rate. Results: 61 patients were enrolled in the trial (31 in electrical arm and 30 in the 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 = 0.0989). Admission to special care unit is more frequent in electrical vs. manual arm (61% vs. 33%, p = 0.0288). Conclusions: there was no difference between the two methods. This could lead to choose the manual suction in a low-resource setting in order to optimize the resources available. Since the midwives could not be masked to the study intervention and since they were more trained in performing manual suction, further studies should be conducted in order to confirm the results. Trial registration: ClinicalTrials.gov with identifier: NCT05472155.