Infant Showing No Response to ResuscitationNCT02181894
Identifying the Most Accurate Method for Predicting the Safe Depth of Orally Placed Neonatal Endotracheal Tubes (ETT).
An observational study of Infant Showing No Response to Resuscitation and Ventilator Adverse Event, run by University of Colorado, Denver at 5 sites in 2 countries.
Trial summary
Placing artificial airways in infants is often performed under emergent life-saving conditions, which necessitates a procedure that is both accurate and efficient. Intubations of the newborn are often necessary before an accurate weight can be reported and estimations are often inaccurate. Read more about this study
- Who is it for?
- Ages 1 minute to 72 hours
- Conditions the study is for
- Infant Showing No Response to Resuscitation, Ventilator Adverse Event, Apparent Life Threatening Event in Newborn and Infant
- Type of treatment
- Pill or oral medicine
- How many people
- 8 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Nov 2014to 1 Jul 2016
- Phase
- Observational
- 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 72 hours
- All sexes
- No healthy volunteers
- Child
Study population: Infants <72 hours of age and orally intubated
Who may be able to join
- Infants orally intubated and admitted into the Neonatal Intensive Care Unit.
Who cannot join
- Previous intubation
- Hydrops fetalis
- Thoracic congenital anomalies
- Facial abnormalities
- Naso-tracheal intubation
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States3 sites
Children's Hospital Colorado
Aurora, Colorado, 80045
University of Colorado Hospital
Aurora, Colorado, 80045
Kaiser Permanente, Los Angeles Medical Center
Los Angeles, California, 90027
Ireland2 sites
The Coombe Women & Infants University Hospital
Dublin
The Rotunda Hospital
Dublin
About this study
Official title: Identifying the Most Accurate Method for Predicting the Safe Depth of Orally Placed Neonatal Endotracheal Tubes.
Placing artificial airways in infants is often performed under emergent life-saving conditions, which necessitates a procedure that is both accurate and efficient. Intubations of the newborn are often necessary before an accurate weight can be reported and estimations are often inaccurate. The current national standard uses body weight to predict the appropriate tube depth yet this approach tends to place the tube too deep for the smallest and most vulnerable neonate; and placement accuracy of any size infant is only 50-70%. The consequence of malpositioned ETTs resulting from poor oxygenation, lung hyperinflation, pneumothoraces and death has been suggested to cost $20 to $54 million annually.
The morbidity and the financial impact suggest an optimal and accurate approach to place ETT in neonates has not been identified. Other methods to estimate the proper depth of the orotracheal tube have shown promise yet no comparison studies have been performed. Identifying the most accurate method to safely place neonatal orotracheal tubes will improve placement precision and reduce adverse events and their associated costs.
Read more
Hypothesis
Compared to weight, sternal to xyphoid length and shoulder to elbow length, the nasal to tragus length will become the most accurate method for predicting the safe depth of orally placed neonatal endotracheal tubes.
- Conditions
- Infant Showing No Response to Resuscitation, Ventilator Adverse Event, Apparent Life Threatening Event in Newborn and Infant
- Keywords
- Infant, Newborn, Neonate, Intubation, Neonatal resuscitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Orally intubated infants | Subjects will be <72 hours of age and orally intubated. Following consent, four measures will be reported (i.e. body weight, nasal to tragus length, suprasternal notch to xyphoid process and shoulder to elbow length). Measures will be compared against a chest x-ray and placement of ETT at the subjects lip to identify the most accurate method to place endotracheal tubes in the newborn. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The differences between 4 measurement methods in placing a neonatal ETT between the lower border of T1 and upper margin of T3 on chest radiograph.
Measured: Up to 3 years
Secondary outcomes (1)
The differences in head position in placing a neonatal ETT between the lower border of T1 and upper margin of T3 on chest radiograph.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2014 (estimated)
- Study startNov 2014
- Primary completion1 Jul 2016
- Study completion1 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant Showing No Response to ResuscitationStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan L Moran, DNP APRN NNP-BC FFNMRCSI, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02181894
- Sponsor's protocol ID
- 14-1117
- Other IDs
- UL1TR001082
- Status last verified
- Jul 2018
- First submitted
- 2 Jul 2014
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying the Most Accurate Method for Predicting the Safe Depth of Orally Placed Neonatal Endotracheal Tubes.
- ClinicalTrials.gov ID
- NCT02181894
- Acronym / sponsor ID
- 14-1117
- Conditions
- Infant Showing No Response to Resuscitation, Ventilator Adverse Event, Apparent Life Threatening Event in Newborn and Infant
- Keywords
- Infant, Newborn, Neonate, Intubation, Neonatal resuscitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- 1 Jul 2016 (actual)
- Study completion
- 1 Jul 2016 (actual)
- First posted
- 4 Jul 2014 (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.
Placing artificial airways in infants is often performed under emergent life-saving conditions, which necessitates a procedure that is both accurate and efficient. Intubations of the newborn are often necessary before an accurate weight can be reported and estimations are often inaccurate. The current national standard uses body weight to predict the appropriate tube depth yet this approach tends to place the tube too deep for the smallest and most vulnerable neonate; and placement accuracy of any size infant is only 50-70%. The consequence of malpositioned ETTs resulting from poor oxygenation, lung hyperinflation, pneumothoraces and death has been suggested to cost $20 to $54 million annually.
The morbidity and the financial impact suggest an optimal and accurate approach to place ETT in neonates has not been identified. Other methods to estimate the proper depth of the orotracheal tube have shown promise yet no comparison studies have been performed. Identifying the most accurate method to safely place neonatal orotracheal tubes will improve placement precision and reduce adverse events and their associated costs.
Hypothesis
Compared to weight, sternal to xyphoid length and shoulder to elbow length, the nasal to tragus length will become the most accurate method for predicting the safe depth of orally placed neonatal endotracheal tubes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orally intubated infants | – | –Subjects will be <72 hours of age and orally intubated. Following consent, four measures will be reported (i.e. body weight, nasal to tragus length, suprasternal notch to xyphoid process and shoulder to elbow length). Measures will be compared against a chest x-ray and placement of ETT at the subjects lip to identify the most accurate method to place endotracheal tubes in the newborn. |
Who may qualify
- Ages
- 1 minute to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants <72 hours of age and orally intubated
Key inclusion criteria (1 listed)
- Infants orally intubated and admitted into the Neonatal Intensive Care Unit.
Key exclusion criteria (5 listed)
- Previous intubation
- Hydrops fetalis
- Thoracic congenital anomalies
- Facial abnormalities
- Naso-tracheal intubation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The differences between 4 measurement methods in placing a neonatal ETT between the lower border of T1 and upper margin of T3 on chest radiograph.
Time frame: Up to 3 years
1 secondary outcome
The differences in head position in placing a neonatal ETT between the lower border of T1 and upper margin of T3 on chest radiograph.
Time frame: Up to 3 years
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 26 Jul 2018.
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.
Susan L Moran, DNP APRN NNP-BC FFNMRCSI principal investigator
Children's Hospital Colorado
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant Showing No Response to Resuscitation and Ventilator Adverse Event, run by University of Colorado, Denver at 5 sites in 2 countries.
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 5 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 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Ireland. 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?
The differences between 4 measurement methods in placing a neonatal ETT between the lower border of T1 and upper margin of T3 on chest radiograph. (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jul 2018.