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

Not Applicable

Completed

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Oropharyngeal suctioning with a suction catheter	Suction catheter	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
Oropharyngeal suctioning with a bulb syringe	Bulb syringe	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

Primary Outcome Measures

Name	Time	Method
Oxygen saturation during the first 10 minutes of life	10 minutes	Preductal oxygen saturation will be measured by a pulse-oxymeter during the first 10 minutes of life

Secondary Outcome Measures

Name	Time	Method
Neonates with heart rate >100 beats per minute at 5 minutes	5 minutes	Number (percentage) of neonates with heart rate \>100 bpm at 5 minutes
Heart rate during the first 10 minutes of life	10 minutes	Heart rate will be monitored by a pulse-oxymeter during the first 10 minutes of life
Neonates with saturation >80% at 5 minutes	5 minutes	Number (percentage) of neonates with saturation \>80% at 5 minutes
Admission to the special care unit	30 minutes	Number (percentage) of infants who were admitted to the special care unit
Episodes of bradycardia in the first 10 minutes of life	10 minutes	Episodes of bradycardia will be defined as heart rate \<100 beats per minute in the first 10 minutes of life
Supplemental oxygen in delivery room	30 minutes	Number (percentage) of infants who needed supplemental oxygen in delivery room
Face-mask ventilation	10 minutes	Number (percentage) of infants who need for face-mask ventilation according to the neonatal algorithm
Respiratory distress during the first 48 hours of life	48 hours	Number (percentage) of infants with respiratory distress (defined as need for supplemental oxygen and/or nasal-CPAP) during the first 48 hours of life
Time for achieving transcutaneous saturations >90%	30 minutes	Time needed for achieving transcutaneous saturations \>90 from birth
Local lesions	10 minutes	Number (percentage) of local lesions (defined as bleeding from the mouth and/or the nose) due to suctioning procedure

Locations (1): St. Luke Catholic Hospital, Wolisso, Ethiopia
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Addis Ababa, Ethiopia