Newborn ResuscitationPEEPrestNCT02971553
PEEP Resuscitation Trial
A study testing Upright Resuscitator with PEEP and Upright Resuscitator in people with Newborn Resuscitation, run by Helse Stavanger HF at 1 site in Tanzania.
Trial summary
Each year, almost 3 million newborn babies die within their first month of life, often as a consequence of labour complications. Approximately 5% of newborns will not start breathing at birth and need immediate help. The optimal ventilation strategy with liquid-filled lungs has not been determined. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Newborn Resuscitation
- What is being tested?
- Upright Resuscitator with PEEP and Upright Resuscitator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteTanzania
- Study dates
- Oct 2016to May 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Neonates who need assisted bag/mask ventilation after birth due to failure to initiate breathing the first 60 seconds after birth.
Who cannot join
- Babies with major deformities not deemed to be viable.
- Missing parental consent
Trial locations and contacts
1 site in 1 country.
Tanzania1 site
Haydom Lutheran Hospital, Research Institute
Haydom, Manyara Region, 9041
About this study
Official title: A Randomised Controlled Trial on Positive End-expiratory Pressure (PEEP) During Resuscitation of Non-breathing Neonates
Each year, almost 3 million newborn babies die within their first month of life, often as a consequence of labour complications. Approximately 5% of newborns will not start breathing at birth and need immediate help. The optimal ventilation strategy with liquid-filled lungs has not been determined. Animal studies suggest that assisted ventilation with positive end expiratory pressure (PEEP) improves the aeration of liquid-filled lungs leading to more rapid recovery. However, no large human clinical studies have investigated the clinical responses to assisted ventilation with PEEP in asphyxiated newborns.
Read the detailed description
Laerdal Global Health has developed a PEEP valve which has been tested and shown to provide reliable end-expiratory pressures in a manikin model, even with a high mask leak. Whether this PEEP valve provides reliable PEEP in vivo and whether this translates to clinical beneficial outcomes remains to be proven.
The aim is to study whether lung aeration can be improved by adding a device for positive end expiratory pressure (PEEP) to better distend the airways in neonates more than 28 weeks gestation.
- Conditions
- Newborn Resuscitation
- Being tested
- Upright Resuscitator with PEEP, Upright Resuscitator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upright Resuscitator with PEEPDevice
Upright ResuscitatorDevice
| Study group | Role | What they receive |
|---|---|---|
| Upright Resuscitator with PEEP | Experimental | Ventilation with the Upright Resuscitator with PEEP Receives: Device: Upright Resuscitator with PEEP |
| Upright Resuscitator | Active comparator | Ventilation with the Upright Resuscitator (without PEEP) Receives: Device: Upright Resuscitator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delta heart rate (beats/minute) during each ventilation sequence
Measured: 10 minutes
Secondary outcomes (5)
Neonatal outcome dead versus alive
Measured: Up to 24 hours
Time to cessation of ventilation
Measured: Up to 1 hour
Time to heart rate above 140 beats/minute
Measured: Up to 1 hour
Mean ariway pressures given
Measured: Up to 1 hour
Time to detection of exhaled CO2 above 1% and 4%
Measured: Up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Newborn 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
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Collaborators
- Haydom Lutheran Hospital
- Responsible party
- Sponsor
- Investigators
- Hussein Kidanto, MD, PhD, Principal investigator, Muhimibili National Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02971553
- Sponsor's protocol ID
- Upright PEEP
- Acronym
- PEEPrest
- Status last verified
- Jun 2019
- First submitted
- 17 Nov 2016
- Last updated
- 12 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Holte K, Ersdal H, Eilevstjonn J, Gomo O, Klingenberg C, Thallinger M, Linde J, Stigum H, Yeconia A, Kidanto H, Stordal K. Positive End-Expiratory Pressure in Newborn Resuscitation Around Term: A Randomized Controlled Trial. Pediatrics. 2020 Oct;146(4):e20200494. doi: 10.1542/peds.2020-0494. Epub 2020 Sep 11.
PubMed 32917847
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial on Positive End-expiratory Pressure (PEEP) During Resuscitation of Non-breathing Neonates
- ClinicalTrials.gov ID
- NCT02971553
- Acronym / sponsor ID
- PEEPrest / Upright PEEP
- Conditions
- Newborn Resuscitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Collaborators
- Haydom Lutheran Hospital
- Study start
- Oct 2016 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 23 Nov 2016 (estimated)
- 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.
Each year, almost 3 million newborn babies die within their first month of life, often as a consequence of labour complications. Approximately 5% of newborns will not start breathing at birth and need immediate help. The optimal ventilation strategy with liquid-filled lungs has not been determined. Animal studies suggest that assisted ventilation with positive end expiratory pressure (PEEP) improves the aeration of liquid-filled lungs leading to more rapid recovery. However, no large human clinical studies have investigated the clinical responses to assisted ventilation with PEEP in asphyxiated newborns.
Detailed description
Laerdal Global Health has developed a PEEP valve which has been tested and shown to provide reliable end-expiratory pressures in a manikin model, even with a high mask leak. Whether this PEEP valve provides reliable PEEP in vivo and whether this translates to clinical beneficial outcomes remains to be proven.
The aim is to study whether lung aeration can be improved by adding a device for positive end expiratory pressure (PEEP) to better distend the airways in neonates more than 28 weeks gestation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upright Resuscitator with PEEP | Experimental | Device: Upright Resuscitator with PEEPVentilation with the Upright Resuscitator with PEEP |
| Upright Resuscitator | Active comparator | Device: Upright ResuscitatorVentilation with the Upright Resuscitator (without PEEP) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Neonates who need assisted bag/mask ventilation after birth due to failure to initiate breathing the first 60 seconds after birth.
Key exclusion criteria (2 listed)
- Babies with major deformities not deemed to be viable.
- Missing parental consent
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 |
|---|---|---|
| Upright Resuscitator with PEEP | Device | Upright Resuscitator with PEEP |
| Upright Resuscitator | Device | Upright Resuscitator |
Primary outcome
Delta heart rate (beats/minute) during each ventilation sequence
Time frame: 10 minutes
5 secondary outcomes
Neonatal outcome dead versus alive
Time frame: Up to 24 hours
Time to cessation of ventilation
Time frame: Up to 1 hour
Time to heart rate above 140 beats/minute
Time frame: Up to 1 hour
Mean ariway pressures given
Time frame: Up to 1 hour
Time to detection of exhaled CO2 above 1% and 4%
Time frame: Up to 1 hour
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 12 Jun 2019.
- Derived from this study: PubMed 32917847Holte K, Ersdal H, Eilevstjonn J, Gomo O, Klingenberg C, Thallinger M, Linde J, Stigum H, Yeconia A, Kidanto H, Stordal K. Positive End-Expiratory Pressure in Newborn Resuscitation Around Term: A Randomized Controlled Trial. Pediatrics. 2020 Oct;146(4):e20200494. doi: 10.1542/peds.2020-0494. Epub 2020 Sep 11.
- Individual participant dataSharing planned: No
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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.
Hussein Kidanto, MD, PhD principal investigator
Muhimibili National Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upright Resuscitator with PEEP and Upright Resuscitator in people with Newborn Resuscitation, run by Helse Stavanger HF at 1 site in Tanzania.
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 1 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 12 Jun 2019. 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 Tanzania. 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?
Delta heart rate (beats/minute) during each ventilation sequence (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 NCT02971553, which also lists 1 linked publication.
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 12 Jun 2019.