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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Neonatal Resuscitation

Intervention / Treatment
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* Device: Bulb syringe
* Device: Suction catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 2 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oropharyngeal suctioning with a bulb syringe<br>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 | Device: Bulb syringe<br>* Suctioning with a bulb syringe<br>|
| Active Comparator: Oropharyngeal suctioning with a suction catheter<br>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 | Device: Suction catheter<br>* Suctioned with a suction catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 10 minutes | 
| Neonates with saturation >80% at 5 minutes | Number (percentage) of neonates with saturation >80% at 5 minutes | 5 minutes | 
| Time for achieving transcutaneous saturations >90% | Time needed for achieving transcutaneous saturations >90 from birth | 30 minutes | 
| Face-mask ventilation | Number (percentage) of infants who need for face-mask ventilation according to the neonatal algorithm | 10 minutes | 
| Supplemental oxygen in delivery room | Number (percentage) of infants who needed supplemental oxygen in delivery room | 30 minutes | 
| Admission to the special care unit | Number (percentage) of infants who were admitted to the special care unit | 30 minutes | 
| Local lesions | Number (percentage) of local lesions (defined as bleeding from the mouth and/or the nose) due to suctioning procedure | 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 | 48 hours |