Effect of Probe Placement in Delivery Room on Temperature at the Admission of Premature Infants?
Primary Purpose
Body Temperature Changes
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
The Back
Chest
Left Axilla
Sponsored by
About this trial
This is an interventional other trial for Body Temperature Changes focused on measuring Temperature-Probe Placement-preterm infant-case room
Eligibility Criteria
Inclusion criteria:
- Preterm infant with gestational age between 28 and 35 6/7 weeks
Exclusion criteria:
- 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.
Sites / Locations
- Hopital Maisonneuve Rosemont
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
The Back
Chest
Left Axilla
Arm Description
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.
The probe is placed on the chest, 1 cm above the left nipple.
The probe is placed deep in the left axilla
Outcomes
Primary Outcome Measures
The average temperature right axillary.
The average temperature axillary at the admission in the Neonatal intensive care unit.
Secondary Outcome Measures
Full Information
NCT ID
NCT02769468
First Posted
April 28, 2016
Last Updated
December 15, 2017
Sponsor
Maisonneuve-Rosemont Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02769468
Brief Title
Effect of Probe Placement in Delivery Room on Temperature at the Admission of Premature Infants?
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?
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maisonneuve-Rosemont Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Temperature Changes
Keywords
Temperature-Probe Placement-preterm infant-case room
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The Back
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Chest
Arm Type
Active Comparator
Arm Description
The probe is placed on the chest, 1 cm above the left nipple.
Arm Title
Left Axilla
Arm Type
Active Comparator
Arm Description
The probe is placed deep in the left axilla
Intervention Type
Other
Intervention Name(s)
The Back
Intervention Type
Other
Intervention Name(s)
Chest
Intervention Type
Other
Intervention Name(s)
Left Axilla
Primary Outcome Measure Information:
Title
The average temperature right axillary.
Description
The average temperature axillary at the admission in the Neonatal intensive care unit.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
28 Weeks
Maximum Age & Unit of Time
36 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Preterm infant with gestational age between 28 and 35 6/7 weeks
Exclusion criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brahim Bensouda, MD
Organizational Affiliation
Maisonneuve-Rosemont Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Maisonneuve Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T2M4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Probe Placement in Delivery Room on Temperature at the Admission of Premature Infants?
We'll reach out to this number within 24 hrs