Body Temperature ChangesNCT02769468
Effect of Probe Placement in Delivery Room on Temperature at the Admission of Premature Infants?
A study testing The Back, Chest and Left Axilla in people with Body Temperature Changes, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
Trial summary
The aim of the study is to compare the effect of 3 different skin temperature placement probe in the case room on the admission temperature to the NICU in preterm infants. The authors aim to evaluate which placement results in more preterm in the acceptable range (36.5-37 °C). Read more about this study
- Who is it for?
- Ages 28 to 36 weeks
- Conditions the study is for
- Body Temperature Changes
- What is being tested?
- The Back, Chest and Left Axilla
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2015to Dec 2016
- 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 28 to 36 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infant with gestational age between 28 and 35 6/7 weeks
Who cannot join
- Infant with severe congenital malformation and those who had sever asphyxia or died in the delivery room and infant born before arrival of NICU team.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Temperature Probe Placement in Delivery Room on Temperature at the Admission in the Neonatal Intensive Care Unit (NICU) of Premature Infants?
The aim of the study is to compare the effect of 3 different skin temperature placement probe in the case room on the admission temperature to the NICU in preterm infants. The authors aim to evaluate which placement results in more preterm in the acceptable range (36.5-37 °C).
Read the detailed description
It's a prospective randomized trial conducted at Maisonneuve Rosemont Hospital, neonatal tertiary center located in Montreal with over 2600 annual deliveries. All pregnant women who are expecting to deliver a preterm infant with gestational between 28 and 35 6/7 weeks will be eligible to be enrolled into the study and informed consent is obtained.
Simple randomization is accomplished by opening a sealed pre-set envelope with group assignment before delivery.
Group 1: The probe is placed lateral from the spine, 1 cm above the intergluteal cleft, and in side position to the flank between the hips and the ribs.
Group 2: The probe is placed on the chest, 1 cm above the left nipple. Group 3: The probe is placed deep in the left axilla
At birth, all the preterm are immediately placed under a radiant warmer and resuscitated as per Neonatal resuscitation program (NRP) guidelines. Application of a skin temperature probe set at 36.5°C, for servo-controlled thermoregulation by 2 minutes of life. Probes will be fixed with an insulated reflective water-soluble gel probe.
No changes are made to the routine delivery room management and resuscitation for this study. After initial delivery room management, babies are transported in a heated radiant warmer (Panda) to the NICU.
In the delivery room, when the baby has a skin temperature servo-controlled stable at 36.5° C, the baby is ready to be transferred to NICU. All babies admitted to the NICU are routinely cared for by the attending neonatologist.
Data collection:
The temperature displaced on the servo controlled table is collected when the baby is the NICU just before transfer from the radiant table to the incubator.
The right axillary temperature will be taken by a thermometer.
- Conditions
- Body Temperature Changes
- Being tested
- The Back, Chest, Left Axilla
- Keywords
- Temperature-Probe Placement-preterm infant-case room
- Medical subject headings
- Body Temperature Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The BackOther
ChestOther
Left AxillaOther
| Study group | Role | What they receive |
|---|---|---|
| The Back | Active comparator | The probe is placed lateral from the spine, 1 cm above the intergluteal cleft, and in side position to the flank between the hips and the ribs. Receives: Other: The Back |
| Chest | Active comparator | The probe is placed on the chest, 1 cm above the left nipple. Receives: Other: Chest |
| Left Axilla | Active comparator | The probe is placed deep in the left axilla Receives: Other: Left Axilla |
What is being measured
The primary outcome is the main question the study is designed to answer.
The average temperature right axillary.
The average temperature axillary at the admission in the Neonatal intensive care unit.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startNov 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Temperature ChangesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maisonneuve-Rosemont Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Brahim Bensouda, Maisonneuve-Rosemont Hospital
- Investigators
- Brahim Bensouda, MD, Principal investigator, Maisonneuve-Rosemont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02769468
- Sponsor's protocol ID
- 15052
- Status last verified
- Dec 2017
- First submitted
- 28 Apr 2016
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Temperature Probe Placement in Delivery Room on Temperature at the Admission in the Neonatal Intensive Care Unit (NICU) of Premature Infants?
- ClinicalTrials.gov ID
- NCT02769468
- Acronym / sponsor ID
- 15052
- Conditions
- Body Temperature Changes
- Keywords
- Temperature-Probe Placement-preterm infant-case room
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Maisonneuve-Rosemont HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 May 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.
The aim of the study is to compare the effect of 3 different skin temperature placement probe in the case room on the admission temperature to the NICU in preterm infants. The authors aim to evaluate which placement results in more preterm in the acceptable range (36.5-37 °C).
Detailed description
It's a prospective randomized trial conducted at Maisonneuve Rosemont Hospital, neonatal tertiary center located in Montreal with over 2600 annual deliveries. All pregnant women who are expecting to deliver a preterm infant with gestational between 28 and 35 6/7 weeks will be eligible to be enrolled into the study and informed consent is obtained.
Simple randomization is accomplished by opening a sealed pre-set envelope with group assignment before delivery.
Group 1: The probe is placed lateral from the spine, 1 cm above the intergluteal cleft, and in side position to the flank between the hips and the ribs.
Group 2: The probe is placed on the chest, 1 cm above the left nipple. Group 3: The probe is placed deep in the left axilla
At birth, all the preterm are immediately placed under a radiant warmer and resuscitated as per Neonatal resuscitation program (NRP) guidelines. Application of a skin temperature probe set at 36.5°C, for servo-controlled thermoregulation by 2 minutes of life. Probes will be fixed with an insulated reflective water-soluble gel probe.
No changes are made to the routine delivery room management and resuscitation for this study. After initial delivery room management, babies are transported in a heated radiant warmer (Panda) to the NICU.
In the delivery room, when the baby has a skin temperature servo-controlled stable at 36.5° C, the baby is ready to be transferred to NICU. All babies admitted to the NICU are routinely cared for by the attending neonatologist.
Data collection:
The temperature displaced on the servo controlled table is collected when the baby is the NICU just before transfer from the radiant table to the incubator.
The right axillary temperature will be taken by a thermometer.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The Back | Active comparator | Other: The BackThe probe is placed lateral from the spine, 1 cm above the intergluteal cleft, and in side position to the flank between the hips and the ribs. |
| Chest | Active comparator | Other: ChestThe probe is placed on the chest, 1 cm above the left nipple. |
| Left Axilla | Active comparator | Other: Left AxillaThe probe is placed deep in the left axilla |
Who may qualify
- Ages
- 28 to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Preterm infant with gestational age between 28 and 35 6/7 weeks
Key exclusion criteria (1 listed)
- Infant with severe congenital malformation and those who had sever asphyxia or died in the delivery room and infant born before arrival of NICU team.
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 |
|---|---|---|
| The Back | Other | The Back |
| Chest | Other | Chest |
| Left Axilla | Other | Left Axilla |
Primary outcome
The average temperature right axillary.
Time frame: 1 year
The average temperature axillary at the admission in the Neonatal intensive care unit.
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 19 Dec 2017.
- Individual participant dataSharing planned: No
Related trials for Body Temperature Changes
RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
Recruiting
Swiss 2024 Continous Fever Monitoring in Pediatric Oncology Patients
Pediatric Oncology Patients With Risk for Infections
RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
Cholelithiasis
RecruitingObservational study
Natural History, Genetics, and Pathophysiology of Systemic Juvenile Idiopathic Arthritis, Adult-Onset Still's Disease, and Related Conditions
Still's Disease, Adult-Onset, Systemic Inflammation
Recruiting
Effect of Buzzy and Virtual Reality on Children Undergoing Venous Procedures
Fever, Children
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.
Brahim Bensouda, MD principal investigator
Maisonneuve-Rosemont 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 The Back, Chest and Left Axilla in people with Body Temperature Changes, run by Maisonneuve-Rosemont Hospital 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 19 Dec 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?
The average temperature right axillary. (time frame: 1 year). 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 19 Dec 2017.