Neonatal ResuscitationNEOSUCNCT05472155
SUCTIONING AT BIRTH WITH BULB SYRINGE OR SUCTION CATHETER: A RANDOMIZED CONTROLLED TRIAL
A study testing Bulb syringe and Suction catheter in people with Neonatal Resuscitation, run by University Hospital Padova at 1 site in Ethiopia.
Trial summary
This study is designed to compare two different methods of oropharyngeal suctioning (with bulb syringe or suction catheter) in newborn infants at birth. Read more about this study
- Who is it for?
- Ages 1 minute to 2 daysHealthy volunteers can take part
- Conditions the study is for
- Neonatal Resuscitation
- What is being tested?
- Bulb syringe and Suction catheter
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEthiopia
- Study dates
- 21 Jul 2022to 30 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 2 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- inborn infants (and)
- need for suctioning at birth (and)
- parental consent
Who cannot join
- Major congenital malformations
- Parental refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
This study is designed to compare two different methods of oropharyngeal suctioning (with bulb syringe or suction catheter) in newborn infants at birth.
Read the 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.
- Conditions
- Neonatal Resuscitation
- Being tested
- Bulb syringe, Suction catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bulb syringeDevice
Suctioning with a bulb syringe
Suction catheterDevice
Suctioned with a suction catheter
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: 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 Receives: Device: Suction catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 minutes
Secondary outcomes (10)
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
Measured: 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
Measured: 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
Measured: 10 minutes
Neonates with saturation >80% at 5 minutes
Number (percentage) of neonates with saturation >80% at 5 minutes
Measured: 5 minutes
Time for achieving transcutaneous saturations >90%
Time needed for achieving transcutaneous saturations >90 from birth
Measured: 30 minutes
Face-mask ventilation
Number (percentage) of infants who need for face-mask ventilation according to the neonatal algorithm
Measured: 10 minutes
Supplemental oxygen in delivery room
Number (percentage) of infants who needed supplemental oxygen in delivery room
Measured: 30 minutes
Admission to the special care unit
Number (percentage) of infants who were admitted to the special care unit
Measured: 30 minutes
Local lesions
Number (percentage) of local lesions (defined as bleeding from the mouth and/or the nose) due to suctioning procedure
Measured: 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
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start21 Jul 2022
- Primary completion30 Oct 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neonatal ResuscitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Padova
- Sponsor type
- University, hospital or other
- Collaborators
- Doctors with Africa - CUAMM
- Responsible party
- Principal investigator, Daniele Trevisanuto, University Hospital Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472155
- Sponsor's protocol ID
- NEOUNIPD3(2022)
- Acronym
- NEOSUC
- Status last verified
- Dec 2023
- First submitted
- 21 Jul 2022
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available upon reasonable request
Publications
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.
PubMed 34193380Foster 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.
PubMed 28419406Lawn 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.
PubMed 24853593Kamath-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.
PubMed 28419084
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SUCTIONING AT BIRTH WITH BULB SYRINGE OR SUCTION CATHETER: A RANDOMIZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT05472155
- Acronym / sponsor ID
- NEOSUC / NEOUNIPD3(2022)
- Conditions
- Neonatal Resuscitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital PadovaUniversity, hospital or other
- Collaborators
- Doctors with Africa - CUAMM
- Study start
- 21 Jul 2022 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 25 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oropharyngeal suctioning with a bulb syringe | Experimental | Device: Bulb syringeNewborn 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 | Device: Suction catheterNewborn infants who have obvious obstruction to spontaneous breathing or who require positive pressure ventilation immediately after birth will be suctioned with a suction catheter |
Who may qualify
- Ages
- 1 minute to 2 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- inborn infants (and)
- need for suctioning at birth (and)
- parental consent
Key exclusion criteria (2 listed)
- Major congenital malformations
- Parental refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bulb syringeSuctioning with a bulb syringe | Device | Oropharyngeal suctioning with a bulb syringe |
| Suction catheterSuctioned with a suction catheter | Device | Oropharyngeal suctioning with a suction catheter |
Primary outcome
Oxygen saturation during the first 10 minutes of life
Time frame: 10 minutes
Preductal oxygen saturation will be measured by a pulse-oxymeter during the first 10 minutes of life
10 secondary outcomes
Heart rate during the first 10 minutes of life
Time frame: 10 minutes
Neonates with heart rate >100 beats per minute at 5 minutes
Time frame: 5 minutes
Episodes of bradycardia in the first 10 minutes of life
Time frame: 10 minutes
Neonates with saturation >80% at 5 minutes
Time frame: 5 minutes
Time for achieving transcutaneous saturations >90%
Time frame: 30 minutes
Face-mask ventilation
Time frame: 10 minutes
Supplemental oxygen in delivery room
Time frame: 30 minutes
Admission to the special care unit
Time frame: 30 minutes
Local lesions
Time frame: 10 minutes
Respiratory distress during the first 48 hours of life
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Results publication: PubMed 34193380Patterson 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.
- Results publication: PubMed 28419406Foster 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.
- Results publication: PubMed 24853593Lawn 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.
- Results publication: PubMed 28419084Kamath-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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be available upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bulb syringe and Suction catheter in people with Neonatal Resuscitation, run by University Hospital Padova at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen saturation during the first 10 minutes of life (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05472155, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.