Newborn InfantNCT01870622
Confirmation of Correct Tracheal Tube Placement in Newborn Infants - a Randomized Control Trial
A study testing Flow waves and ECO2 in people with Newborn Infant, run by University of Alberta at 1 site in Canada.
Trial summary
Most premature babies have difficulty breathing at birth and need help (resuscitation). The treatment for this is to gently inflate their lungs with a resuscitation device and a facemask. Read more about this study
- Who is it for?
- Ages Up to 120 days
- Conditions the study is for
- Newborn Infant
- What is being tested?
- Flow waves and ECO2
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2013to Oct 2014
- 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 Up to 120 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All infants (term and preterm) born at The Royal Alexandra Hospital who require endotracheal intubation in the delivery room or neonatal intensive care unit will be recorded.
Who cannot join
- Infants will also be excluded if their parents refuse to give consent to this study.
Trial locations and contacts
1 site in 1 country.
About this study
Most premature babies have difficulty breathing at birth and need help (resuscitation). The treatment for this is to gently inflate their lungs with a resuscitation device and a facemask. To gently inflate an infant's lungs the clinical team places a breathing tube in the windpipe and blow air into your baby's lung (puffs). With the first puffs the clinical team checks if the breathing tube is correctly placed within the windpipe. The investigators routinely use a detector which checks for exhaled carbon dioxide or the graphical display of waves forms of the infants breathing to check that the breathing tube position. However, the investigators do not know which one (exhaled carbon dioxide or the graphical display of waves forms) is better to check that the breathing tube position is correct and therefore the investigators would like to study them. The purpose of this study is to compare exhaled carbon dioxide detectors (ECO2 group) with the graphical display of waves forms (flow waves group) to provide us with information on how the investigators can help babies who struggle with breathing at birth.
- Conditions
- Newborn Infant
- Being tested
- Flow waves, ECO2
- Keywords
- Newborn,, Infant,, Endotracheal Intubation,, Carbon dioxide detector,, Flow waves
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow wavesProcedure or surgery
Flow waves will be used to confirm correct tube placement in newborn infants.
ECO2Procedure or surgery
ECO2 will be used to confirm correct tube placement in newborn infants.
| Study group | Role | What they receive |
|---|---|---|
| ECO2 | Active comparator | ECO2 will be used to confirm correct tube placement in newborn infants. Receives: Procedure: ECO2 |
| Flow waves | Experimental | Flow waves will be used to confirm correct tube placement Receives: Procedure: Flow waves |
What is being measured
The primary outcome is the main question the study is designed to answer.
Using flow waves will increase the percentage of correct tube placement in newborn infants
Flow waves and exhaled Carbon dioxide will be compared using the numbers of inflation needed to identify correct tube placement.
We will compare the number of inflation in each group to identify which device can identify correct tube placement faster and more accurately.
Outcome will be number of inflation until correct tube placement has been identified.
Measured: within the first 10 inflations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Newborn InfantStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01870622
- Sponsor's protocol ID
- Pro00036974
- Status last verified
- Mar 2017
- First submitted
- 29 May 2013
- Last updated
- 15 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schmolzer GM, O'Reilly M, Davis PG, Cheung PY, Roehr CC. Confirmation of correct tracheal tube placement in newborn infants. Resuscitation. 2013 Jun;84(6):731-7. doi: 10.1016/j.resuscitation.2012.11.028. Epub 2012 Dec 1.
PubMed 23211476Schmolzer GM, Poulton DA, Dawson JA, Kamlin CO, Morley CJ, Davis PG. Assessment of flow waves and colorimetric CO2 detector for endotracheal tube placement during neonatal resuscitation. Resuscitation. 2011 Mar;82(3):307-12. doi: 10.1016/j.resuscitation.2010.11.008. Epub 2010 Dec 16.
PubMed 21167628Schmolzer GM, Hooper SB, Crossley KJ, Allison BJ, Morley CJ, Davis PG. Assessment of gas flow waves for endotracheal tube placement in an ovine model of neonatal resuscitation. Resuscitation. 2010 Jun;81(6):737-41. doi: 10.1016/j.resuscitation.2010.02.018. Epub 2010 Mar 23.
PubMed 20334964Aziz HF, Martin JB, Moore JJ. The pediatric disposable end-tidal carbon dioxide detector role in endotracheal intubation in newborns. J Perinatol. 1999 Mar;19(2):110-3. doi: 10.1038/sj.jp.7200136.
PubMed 10642970Hosono S, Inami I, Fujita H, Minato M, Takahashi S, Mugishima H. A role of end-tidal CO(2) monitoring for assessment of tracheal intubations in very low birth weight infants during neonatal resuscitation at birth. J Perinat Med. 2009;37(1):79-84. doi: 10.1515/JPM.2009.017.
PubMed 18976048O'Donnell CP, Kamlin CO, Davis PG, Morley CJ. Endotracheal intubation attempts during neonatal resuscitation: success rates, duration, and adverse effects. Pediatrics. 2006 Jan;117(1):e16-21. doi: 10.1542/peds.2005-0901.
PubMed 16396845Leone TA, Rich W, Finer NN. Neonatal intubation: success of pediatric trainees. J Pediatr. 2005 May;146(5):638-41. doi: 10.1016/j.jpeds.2005.01.029.
PubMed 15870667
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confirmation of Correct Tracheal Tube Placement in Newborn Infants - a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT01870622
- Acronym / sponsor ID
- Pro00036974
- Conditions
- Newborn Infant
- Keywords
- Newborn,, Infant,, Endotracheal Intubation,, Carbon dioxide detector,, Flow waves
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 6 Jun 2013 (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.
Most premature babies have difficulty breathing at birth and need help (resuscitation). The treatment for this is to gently inflate their lungs with a resuscitation device and a facemask. To gently inflate an infant's lungs the clinical team places a breathing tube in the windpipe and blow air into your baby's lung (puffs). With the first puffs the clinical team checks if the breathing tube is correctly placed within the windpipe. The investigators routinely use a detector which checks for exhaled carbon dioxide or the graphical display of waves forms of the infants breathing to check that the breathing tube position. However, the investigators do not know which one (exhaled carbon dioxide or the graphical display of waves forms) is better to check that the breathing tube position is correct and therefore the investigators would like to study them. The purpose of this study is to compare exhaled carbon dioxide detectors (ECO2 group) with the graphical display of waves forms (flow waves group) to provide us with information on how the investigators can help babies who struggle with breathing at birth.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECO2 | Active comparator | Procedure: ECO2ECO2 will be used to confirm correct tube placement in newborn infants. |
| Flow waves | Experimental | Procedure: Flow wavesFlow waves will be used to confirm correct tube placement |
Who may qualify
- Ages
- Up to 120 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All infants (term and preterm) born at The Royal Alexandra Hospital who require endotracheal intubation in the delivery room or neonatal intensive care unit will be recorded.
Key exclusion criteria (1 listed)
- Infants will also be excluded if their parents refuse to give consent to this 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 |
|---|---|---|
| Flow wavesFlow waves will be used to confirm correct tube placement in newborn infants. | Procedure or surgery | Flow waves |
| ECO2ECO2 will be used to confirm correct tube placement in newborn infants. | Procedure or surgery | ECO2 |
Primary outcome
Using flow waves will increase the percentage of correct tube placement in newborn infants
Time frame: within the first 10 inflations
Flow waves and exhaled Carbon dioxide will be compared using the numbers of inflation needed to identify correct tube placement. We will compare the number of inflation in each group to identify which device can identify correct tube placement faster and more accurately. Outcome will be number of inflation until correct tube placement has been identified.
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 15 Mar 2017.
- Background: PubMed 23211476Schmolzer GM, O'Reilly M, Davis PG, Cheung PY, Roehr CC. Confirmation of correct tracheal tube placement in newborn infants. Resuscitation. 2013 Jun;84(6):731-7. doi: 10.1016/j.resuscitation.2012.11.028. Epub 2012 Dec 1.
- Background: PubMed 21167628Schmolzer GM, Poulton DA, Dawson JA, Kamlin CO, Morley CJ, Davis PG. Assessment of flow waves and colorimetric CO2 detector for endotracheal tube placement during neonatal resuscitation. Resuscitation. 2011 Mar;82(3):307-12. doi: 10.1016/j.resuscitation.2010.11.008. Epub 2010 Dec 16.
- Background: PubMed 20334964Schmolzer GM, Hooper SB, Crossley KJ, Allison BJ, Morley CJ, Davis PG. Assessment of gas flow waves for endotracheal tube placement in an ovine model of neonatal resuscitation. Resuscitation. 2010 Jun;81(6):737-41. doi: 10.1016/j.resuscitation.2010.02.018. Epub 2010 Mar 23.
- Background: PubMed 10642970Aziz HF, Martin JB, Moore JJ. The pediatric disposable end-tidal carbon dioxide detector role in endotracheal intubation in newborns. J Perinatol. 1999 Mar;19(2):110-3. doi: 10.1038/sj.jp.7200136.
- Background: PubMed 18976048Hosono S, Inami I, Fujita H, Minato M, Takahashi S, Mugishima H. A role of end-tidal CO(2) monitoring for assessment of tracheal intubations in very low birth weight infants during neonatal resuscitation at birth. J Perinat Med. 2009;37(1):79-84. doi: 10.1515/JPM.2009.017.
- Background: PubMed 16396845O'Donnell CP, Kamlin CO, Davis PG, Morley CJ. Endotracheal intubation attempts during neonatal resuscitation: success rates, duration, and adverse effects. Pediatrics. 2006 Jan;117(1):e16-21. doi: 10.1542/peds.2005-0901.
- Background: PubMed 15870667Leone TA, Rich W, Finer NN. Neonatal intubation: success of pediatric trainees. J Pediatr. 2005 May;146(5):638-41. doi: 10.1016/j.jpeds.2005.01.029.
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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 Flow waves and ECO2 in people with Newborn Infant, run by University of Alberta at 1 site in Canada.
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 1 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 15 Mar 2017. 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 Canada. 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?
Using flow waves will increase the percentage of correct tube placement in newborn infants (time frame: within the first 10 inflations). 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 NCT01870622, which also lists 7 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 15 Mar 2017.