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

University Hospital Padova

Status: Completed

Conditions: Neonatal Resuscitation

Treatments: Device: Suction catheter; Device: Bulb syringe

Study type: Interventional

Funder types: Other

Identifiers

NCT05472155

NEOUNIPD3(2022)

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 1 minute to 2 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• inborn infants (and)
• need for suctioning at birth (and)
• parental consent

Exclusion criteria

• Major congenital malformations
• Parental refusal to participate in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Oropharyngeal suctioning with a bulb syringe

Experimental group

Description:

Newborn infants who have obvious obstruction to spontaneous breathing or who require positive pressure ventilation immediately after birth will be suctioned with a bulb syringe

Treatment:

Device: Bulb syringe

Oropharyngeal suctioning with a suction catheter

Active Comparator group

Description:

Newborn infants who have obvious obstruction to spontaneous breathing or who require positive pressure ventilation immediately after birth will be suctioned with a suction catheter

Treatment:

Device: Suction catheter