NCT05472155

SUCTIONING AT BIRTH WITH BULB SYRINGE OR SUCTION CATHETER: A RANDOMIZED CONTROLLED TRIAL

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University Hospital Padova · Academic / Other
• Sex: All
• Age: 1 Minute – 2 Days
• Healthy volunteers: Accepted

Summary

This study is designed to compare two different methods of oropharyngeal suctioning (with bulb syringe or suction catheter) in newborn infants at birth.

Detailed description

Objective of the study: This trial aims to compare two different methods of oropharyngeal suctioning (with bulb syringe or suction catheter) in newborn infants needing suctioning at birth. Primary outcome measure: Oxygen saturation during the first 10 minutes of life. Study design: 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. Setting: The study is conducted at the St. Luke Catholic Hospital in Wolisso (Ethiopia), which is a level III hospital with around 3,600 deliveries per year. Immediately after birth, all infants needing suctioning are randomized to receive suctioning with bulb syringe or suction catheter. All resuscitative procedures are performed following the Helping Babies Breathe algorithm. An external observer, not involved in the care of the newborn, is responsible of the positioning the probe of the pulse oximeter and the collection of the data. We aim to enroll 60 neonates.

Conditions

• Neonatal Resuscitation

Interventions

Type	Name	Description
DEVICE	Bulb syringe	Suctioning with a bulb syringe
DEVICE	Suction catheter	Suctioned with a suction catheter

Timeline

• Start date: 2022-07-21
• Primary completion: 2022-10-30
• Completion: 2022-10-30
• First posted: 2022-07-25
• Last updated: 2023-12-05

Locations

1 site across 1 country: Ethiopia