Neonatal Resuscitation
Conditions
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.
Interventions
DEVICEBulb syringe
Suctioning with a bulb syringe
DEVICESuction catheter
Suctioned with a suction catheter
Sponsors
Doctors with Africa - CUAMM
University Hospital Padova
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Masking is not possible due to the study design. Only statistician who will perform the analysis will be blind to the arm allocation.
Eligibility
Sex/Gender
ALL
Age
1 Minutes to 2 Days
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Neonates with saturation >80% at 5 minutes | 5 minutes | Number (percentage) of neonates with saturation \>80% at 5 minutes |
| Time for achieving transcutaneous saturations >90% | 30 minutes | Time needed for achieving transcutaneous saturations \>90 from birth |
| 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 |
| Supplemental oxygen in delivery room | 30 minutes | Number (percentage) of infants who needed supplemental oxygen in delivery room |
| Admission to the special care unit | 30 minutes | Number (percentage) of infants who were admitted to the special care unit |
| Local lesions | 10 minutes | Number (percentage) of local lesions (defined as bleeding from the mouth and/or the nose) due to suctioning procedure |
| 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 |
| Face-mask ventilation | 10 minutes | Number (percentage) of infants who need for face-mask ventilation according to the neonatal algorithm |
Countries
Ethiopia
Outcome results
None listed