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| Name | Class |
|---|---|
| Doctors with Africa - CUAMM | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oropharyngeal suctioning with a bulb syringe | Experimental | 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 |
|
| Oropharyngeal suctioning with a suction catheter | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bulb syringe | Device | Suctioning with a bulb syringe |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Luke Catholic Hospital, Wolisso, Ethiopia | Addis Ababa | Ethiopia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34193380 | Result | Patterson J, North K, Dempsey E, Ishoso D, Trevisanuto D, Lee AC, Kamath-Rayne BD; Newborn Brain Society Guidelines and Publications Committee. Optimizing initial neonatal resuscitation to reduce neonatal encephalopathy around the world. Semin Fetal Neonatal Med. 2021 Aug;26(4):101262. doi: 10.1016/j.siny.2021.101262. Epub 2021 Jun 22. | |
| 28419406 |
| Label | URL |
|---|---|
| Related Info | View source |
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Data will be available upon reasonable request
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Masking is not possible due to the study design. Only statistician who will perform the analysis will be blind to the arm allocation.
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| Suction catheter |
| Device |
Suctioned with a suction catheter |
|
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 |
| Foster JP, Dawson JA, Davis PG, Dahlen HG. Routine oro/nasopharyngeal suction versus no suction at birth. Cochrane Database Syst Rev. 2017 Apr 18;4(4):CD010332. doi: 10.1002/14651858.CD010332.pub2. |
| 24853593 | Result | Lawn JE, Blencowe H, Oza S, You D, Lee AC, Waiswa P, Lalli M, Bhutta Z, Barros AJ, Christian P, Mathers C, Cousens SN; Lancet Every Newborn Study Group. Every Newborn: progress, priorities, and potential beyond survival. Lancet. 2014 Jul 12;384(9938):189-205. doi: 10.1016/S0140-6736(14)60496-7. Epub 2014 May 19. |
| 28419084 | Result | Kamath-Rayne BD, Berkelhamer SK, Kc A, Ersdal HL, Niermeyer S. Neonatal resuscitation in global health settings: an examination of the past to prepare for the future. Pediatr Res. 2017 Aug;82(2):194-200. doi: 10.1038/pr.2017.48. Epub 2017 May 24. |