Body TemperatureNCT02311972
Temperature Monitoring With InnerSense Esophageal Temperature Sensor/Feeding Tube After Birth Through Stabilization in VLBW Infants
A study testing Philips InnerSense Esophageal Temperature Sensor/Feeding Tube in people with Body Temperature, run by Duke University at 1 site in United States.
Trial summary
Very low birth weight (VLBW) infants (<1500 grams at birth) and other low birth weight infants experience hypothermia after birth and through stabilization (first 24 hours of life) due to an inability to keep warm through metabolic heat production while experiencing heat loss during care. Read more about this study
- Who is it for?
- Ages 1 minute to 24 hours
- Conditions the study is for
- Body Temperature
- What is being tested?
- Philips InnerSense Esophageal Temperature Sensor/Feeding Tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 24 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parents of eligible infants must be enrolled prior to, or shortly after delivery as the InnerSense esophageal temperature sensor/feeding tube will be inserted post delivery resuscitation
Who cannot join
- Infants are excluded if parents were not consented prior to, or shortly after delivery
- Infants are not eligible if they have major congenital anomalies including gastrointestinal or facial abnormalities
- Infants with major cardiac anomalies are also excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Very low birth weight (VLBW) infants (<1500 grams at birth) and other low birth weight infants experience hypothermia after birth and through stabilization (first 24 hours of life) due to an inability to keep warm through metabolic heat production while experiencing heat loss during care.
The investigator hypothesizes that inserting an InnerSense oral gastric tube (Philips Healthcare) with its imbedded thermistor and attaching the tube to a temperature monitor with a digital temperature display will enable care-providers to monitor continuous body temperature and prompt them to provide warmth and prevent heat loss, thus preventing hypothermia in these infants for the first 24 hours of life. The investigator predicts infants in the intervention group will have warmer axillary temperatures upon admission to the NICU and at 1, 4, and 8 hours of age. Mothers in non-active labor will be sought for consent to enroll their VLBW infant into this study after the infant's birth. 160 VLBW infants and other low birth weight infants 1000-2000 grams will be randomized to the intervention group (placement of InnerSense oral gastric tube with thermistor to a Squirrel monitor for continuous digital temperature display, immediately after birth through 24 hours of life) or the control group (standard delivery room care and stabilization care). The study staff plans to enroll 180 infants (90 per group) to allow for screen failures. Axillary temperatures of all infants will be recorded at NICU admission, 1, 4, 8 and 24 hours of age. Further, the study staff intends to enroll approximately 300 Intensive Care Nursery providers who care for an InnerSense study infant and wish to complete a provider satisfaction survey. These providers will be asked to provide consent prior to completing the survey and their names will be recorded on a separate study enrollment log.
Infant demographic data will be compared to make sure groups are not significantly different. Temperatures from the intervention group will be compared to the control group using a student t test at each time point. Satisfaction questionnaires will be summarized and described. The InnerSense oral gastric tube with temperature monitoring is FDA approved for use and is being marketed commercially by Philips Healthcare. VLBW infants have oral gastric tubes placed as standard of care for feeding, and intermittently in the delivery room when positive pressure ventilation is necessary for respiratory stabilization. There are no additional safety risks to the intervention of this study; however, a safety/data monitoring committee will be formed and meet quarterly to monitor the trial.
- Conditions
- Body Temperature
- Being tested
- Philips InnerSense Esophageal Temperature Sensor/Feeding Tube, Standard of care feeding tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Philips InnerSense Esophageal Temperature Sensor/Feeding TubeDevice
Standard of care feeding tubeDevice
| Study group | Role | What they receive |
|---|---|---|
| Control - Standard of Care | Active comparator | Infants in the standard of care group will receive no study interventions other than study recorded axillary temperatures on admission, and at 1, 4, 8 and 24 hours. Infants will receive standard delivery room stabilization and NICU stabilization. Infants in the control group will receive a feeding tube as standard of care, and the standard issue feeding tube used in the Intensive Care Nursery does not have the capability to record or display esophageal temperatures. Nurses will record an axillary temperature upon admission to the NICU, and at 1, 4, 8 and 24 hours of age for each infant in both groups on a data sheet at the bedside. These data will be entered into a RedCap data base created for the study. Receives: Device: Standard of care feeding tube |
| Philips InnerSense Esophageal Temperature Sensor/Feeding Tube | Active comparator | The nurse will insert an InnerSense temperature sensor/feeding tube per normal standards as soon after birth as possible, during delivery room stabilization. Nurses will record an axillary temperature upon admission to the NICU, and at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life. All temperatures entered into the study database. Receives: Device: Philips InnerSense Esophageal Temperature Sensor/Feeding Tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Axillary Admission Temperature
Mean axillary temperatures upon Admission from infants in the InnerSense group and the standard of care group will be compared to determine if a significant difference
Measured: Admission
Mean Axillary Temperature at 4 Hours of Infant Life
The mean axillary temperature at 4 hours of age will be compared for infants in the InnerSense group and the standard of care group to determine if a significant difference is seen at 4 hours of life.
Measured: 4 Hours of Infant Life
Secondary outcomes (5)
Percentage of Infants With Hypothermic Temperatures (<36.5° C) Upon Admission
Axillary temperatures for infants in the InnerSense group and infants in the standard of care group will be compared on admission to determine the percentage of hypothermia in both groups.
Measured: Admission
Percentage of Infants With Hypothermic Temperatures (<36.5° C) at 1 Hour of Infant Life
Axillary temperatures for infants in the InnerSense group and infants in the standard of care group will be compared at 1 hour to determine the percentage of hypothermia in both groups.
Measured: 1 Hour of Infant Life
Percentage of Infants With Hypothermic Temperatures (<36.5° C) at 4 Hours of Infant Life
Axillary temperatures for infants in the InnerSense group and infants in the standard of care group will be compared at 4 hours to determine the percentage of hypothermia in both groups.
Measured: 4 Hours of Infant Life
Percentage of Infants With Hypothermic Temperatures (<36.5° C) at 8 Hours of Infant Life
Axillary temperatures for infants in the InnerSense group and infants in the standard of care group will be compared at 8 hours to determine the percentage of hypothermia in both groups.
Measured: 8 Hours of Infant Life
Pearson Correlation Coefficient Comparing Thermistor Abdominal Temperature to Esophageal Temperature in Each Infant in the Experimental Arm.
Temperatures measured by the abdomen thermistor will be compared with esophageal temperatures in each infant over 24 hours using pearson correlation coefficient.
Measured: Admission to 24 hours of infant life.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionApr 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Body TemperatureStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Healthcare
- Responsible party
- Sponsor
- Investigators
- Robin B Dail (Knobel), PhD, RN, FAAN, Principal investigator, Duke University School of Nursing & School of Medicine, Department of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02311972
- Sponsor's protocol ID
- Pro00051454
- Status last verified
- May 2017
- First submitted
- 4 Dec 2014
- Last updated
- 14 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Martin JA, Hamilton BE, Ventura SJ, Osterman MJ, Mathews TJ. Births: final data for 2011. Natl Vital Stat Rep. 2013 Jun 28;62(1):1-69, 72.
PubMed 24974591Bhatt DR, White R, Martin G, Van Marter LJ, Finer N, Goldsmith JP, Ramos C, Kukreja S, Ramanathan R. Transitional hypothermia in preterm newborns. J Perinatol. 2007 Dec;27 Suppl 2:S45-7. doi: 10.1038/sj.jp.7211842.
PubMed 18034181Basu S, Rathore P, Bhatia BD. Predictors of mortality in very low birth weight neonates in India. Singapore Med J. 2008 Jul;49(7):556-60.
PubMed 18695864Laptook AR, Salhab W, Bhaskar B; Neonatal Research Network. Admission temperature of low birth weight infants: predictors and associated morbidities. Pediatrics. 2007 Mar;119(3):e643-9. doi: 10.1542/peds.2006-0943. Epub 2007 Feb 12.
PubMed 17296783Knobel RB, Wimmer JE Jr, Holbert D. Heat loss prevention for preterm infants in the delivery room. J Perinatol. 2005 May;25(5):304-8. doi: 10.1038/sj.jp.7211289.
PubMed 15861196Almeida PG, Chandley J, Davis J, Harrigan RC. Use of the heated gel mattress and its impact on admission temperature of very low birth-weight infants. Adv Neonatal Care. 2009 Feb;9(1):34-9. doi: 10.1097/01.ANC.0000346094.28110.11.
PubMed 19212164te Pas AB, Lopriore E, Dito I, Morley CJ, Walther FJ. Humidified and heated air during stabilization at birth improves temperature in preterm infants. Pediatrics. 2010 Jun;125(6):e1427-32. doi: 10.1542/peds.2009-2656. Epub 2010 May 10.
PubMed 20457686
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temperature Monitoring With InnerSense Esophageal Temperature Sensor/Feeding Tube After Birth Through Stabilization in VLBW Infants
- ClinicalTrials.gov ID
- NCT02311972
- Acronym / sponsor ID
- Pro00051454
- Conditions
- Body Temperature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Philips Healthcare
- Study start
- Nov 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 9 Dec 2014 (estimated)
- Results
- Posted 14 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Very low birth weight (VLBW) infants (<1500 grams at birth) and other low birth weight infants experience hypothermia after birth and through stabilization (first 24 hours of life) due to an inability to keep warm through metabolic heat production while experiencing heat loss during care.
The investigator hypothesizes that inserting an InnerSense oral gastric tube (Philips Healthcare) with its imbedded thermistor and attaching the tube to a temperature monitor with a digital temperature display will enable care-providers to monitor continuous body temperature and prompt them to provide warmth and prevent heat loss, thus preventing hypothermia in these infants for the first 24 hours of life. The investigator predicts infants in the intervention group will have warmer axillary temperatures upon admission to the NICU and at 1, 4, and 8 hours of age. Mothers in non-active labor will be sought for consent to enroll their VLBW infant into this study after the infant's birth. 160 VLBW infants and other low birth weight infants 1000-2000 grams will be randomized to the intervention group (placement of InnerSense oral gastric tube with thermistor to a Squirrel monitor for continuous digital temperature display, immediately after birth through 24 hours of life) or the control group (standard delivery room care and stabilization care). The study staff plans to enroll 180 infants (90 per group) to allow for screen failures. Axillary temperatures of all infants will be recorded at NICU admission, 1, 4, 8 and 24 hours of age. Further, the study staff intends to enroll approximately 300 Intensive Care Nursery providers who care for an InnerSense study infant and wish to complete a provider satisfaction survey. These providers will be asked to provide consent prior to completing the survey and their names will be recorded on a separate study enrollment log.
Infant demographic data will be compared to make sure groups are not significantly different. Temperatures from the intervention group will be compared to the control group using a student t test at each time point. Satisfaction questionnaires will be summarized and described. The InnerSense oral gastric tube with temperature monitoring is FDA approved for use and is being marketed commercially by Philips Healthcare. VLBW infants have oral gastric tubes placed as standard of care for feeding, and intermittently in the delivery room when positive pressure ventilation is necessary for respiratory stabilization. There are no additional safety risks to the intervention of this study; however, a safety/data monitoring committee will be formed and meet quarterly to monitor the trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control - Standard of Care | Active comparator | Device: Standard of care feeding tubeInfants in the standard of care group will receive no study interventions other than study recorded axillary temperatures on admission, and at 1, 4, 8 and 24 hours. Infants will receive standard delivery room stabilization and NICU stabilization. Infants in the control group will receive a feeding tube as standard of care, and the standard issue feeding tube used in the Intensive Care Nursery does not have the capability to record or display esophageal temperatures. Nurses will record an axillary temperature upon admission to the NICU, and at 1, 4, 8 and 24 hours of age for each infant in both groups on a data sheet at the bedside. These data will be entered into a RedCap data base created for the study. |
| Philips InnerSense Esophageal Temperature Sensor/Feeding Tube | Active comparator | Device: Philips InnerSense Esophageal Temperature Sensor/Feeding TubeThe nurse will insert an InnerSense temperature sensor/feeding tube per normal standards as soon after birth as possible, during delivery room stabilization. Nurses will record an axillary temperature upon admission to the NICU, and at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life. All temperatures entered into the study database. |
Who may qualify
- Ages
- 1 minute to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Parents of eligible infants must be enrolled prior to, or shortly after delivery as the InnerSense esophageal temperature sensor/feeding tube will be inserted post delivery resuscitation
Key exclusion criteria (3 listed)
- Infants are excluded if parents were not consented prior to, or shortly after delivery
- Infants are not eligible if they have major congenital anomalies including gastrointestinal or facial abnormalities
- Infants with major cardiac anomalies are also excluded
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 |
|---|---|---|
| Philips InnerSense Esophageal Temperature Sensor/Feeding Tube | Device | Philips InnerSense Esophageal Temperature Sensor/Feeding Tube |
| Standard of care feeding tube | Device | Control - Standard of Care |
Primary outcome
Mean Axillary Admission Temperature
Time frame: Admission
Mean axillary temperatures upon Admission from infants in the InnerSense group and the standard of care group will be compared to determine if a significant difference
Mean Axillary Temperature at 4 Hours of Infant Life
Time frame: 4 Hours of Infant Life
The mean axillary temperature at 4 hours of age will be compared for infants in the InnerSense group and the standard of care group to determine if a significant difference is seen at 4 hours of life.
5 secondary outcomes
Percentage of Infants With Hypothermic Temperatures (<36.5° C) Upon Admission
Time frame: Admission
Percentage of Infants With Hypothermic Temperatures (<36.5° C) at 1 Hour of Infant Life
Time frame: 1 Hour of Infant Life
Percentage of Infants With Hypothermic Temperatures (<36.5° C) at 4 Hours of Infant Life
Time frame: 4 Hours of Infant Life
Percentage of Infants With Hypothermic Temperatures (<36.5° C) at 8 Hours of Infant Life
Time frame: 8 Hours of Infant Life
Pearson Correlation Coefficient Comparing Thermistor Abdominal Temperature to Esophageal Temperature in Each Infant in the Experimental Arm.
Time frame: Admission to 24 hours of infant life.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24974591Martin JA, Hamilton BE, Ventura SJ, Osterman MJ, Mathews TJ. Births: final data for 2011. Natl Vital Stat Rep. 2013 Jun 28;62(1):1-69, 72.
- Background: PubMed 18034181Bhatt DR, White R, Martin G, Van Marter LJ, Finer N, Goldsmith JP, Ramos C, Kukreja S, Ramanathan R. Transitional hypothermia in preterm newborns. J Perinatol. 2007 Dec;27 Suppl 2:S45-7. doi: 10.1038/sj.jp.7211842.
- Background: PubMed 18695864Basu S, Rathore P, Bhatia BD. Predictors of mortality in very low birth weight neonates in India. Singapore Med J. 2008 Jul;49(7):556-60.
- Background: PubMed 17296783Laptook AR, Salhab W, Bhaskar B; Neonatal Research Network. Admission temperature of low birth weight infants: predictors and associated morbidities. Pediatrics. 2007 Mar;119(3):e643-9. doi: 10.1542/peds.2006-0943. Epub 2007 Feb 12.
- Background: PubMed 15861196Knobel RB, Wimmer JE Jr, Holbert D. Heat loss prevention for preterm infants in the delivery room. J Perinatol. 2005 May;25(5):304-8. doi: 10.1038/sj.jp.7211289.
- Background: PubMed 19212164Almeida PG, Chandley J, Davis J, Harrigan RC. Use of the heated gel mattress and its impact on admission temperature of very low birth-weight infants. Adv Neonatal Care. 2009 Feb;9(1):34-9. doi: 10.1097/01.ANC.0000346094.28110.11.
- Background: PubMed 20457686te Pas AB, Lopriore E, Dito I, Morley CJ, Walther FJ. Humidified and heated air during stabilization at birth improves temperature in preterm infants. Pediatrics. 2010 Jun;125(6):e1427-32. doi: 10.1542/peds.2009-2656. Epub 2010 May 10.
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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.
Robin B Dail (Knobel), PhD, RN, FAAN principal investigator
Duke University School of Nursing & School of Medicine, Department of Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Philips InnerSense Esophageal Temperature Sensor/Feeding Tube in people with Body Temperature, run by Duke University at 1 site in United States.
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 3 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 14 Jun 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 United States. 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?
Yes. Results are posted in the registry (first posted 14 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Axillary Admission Temperature (time frame: Admission). The study lists 2 primary outcomes in all. 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 NCT02311972, 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 14 Jun 2017.