This study is designed to compare two different methods of oropharyngeal suctioning (with bulb syringe or suction catheter) in newborn infants at birth.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Suctioning with a bulb syringe
Suctioned with a suction catheter
St. Luke Catholic Hospital, Wolisso, Ethiopia
Addis Ababa, Ethiopia
Oxygen saturation during the first 10 minutes of life
Preductal oxygen saturation will be measured by a pulse-oxymeter during the first 10 minutes of life
Time frame: 10 minutes
Heart rate during the first 10 minutes of life
Heart rate will be monitored by a pulse-oxymeter during the first 10 minutes of life
Time frame: 10 minutes
Neonates with heart rate >100 beats per minute at 5 minutes
Number (percentage) of neonates with heart rate \>100 bpm at 5 minutes
Time frame: 5 minutes
Episodes of bradycardia in the first 10 minutes of life
Episodes of bradycardia will be defined as heart rate \<100 beats per minute in the first 10 minutes of life
Time frame: 10 minutes
Neonates with saturation >80% at 5 minutes
Number (percentage) of neonates with saturation \>80% at 5 minutes
Time frame: 5 minutes
Time for achieving transcutaneous saturations >90%
Time needed for achieving transcutaneous saturations \>90 from birth
Time frame: 30 minutes
Face-mask ventilation
Number (percentage) of infants who need for face-mask ventilation according to the neonatal algorithm
Time frame: 10 minutes
Supplemental oxygen in delivery room
Number (percentage) of infants who needed supplemental oxygen in delivery room
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Time frame: 30 minutes
Admission to the special care unit
Number (percentage) of infants who were admitted to the special care unit
Time frame: 30 minutes
Local lesions
Number (percentage) of local lesions (defined as bleeding from the mouth and/or the nose) due to suctioning procedure
Time frame: 10 minutes
Respiratory distress during the first 48 hours of life
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 frame: 48 hours