Effect of Probe Placement in Delivery Room on Temperature at the Admission of Premature Infants?

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).

Study Overview

• Status: Completed
• Conditions: Body Temperature Changes
• Intervention / Treatment: Other: The Back; Other: Chest; Other: Left Axilla

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 Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H1T2M4
      • Hôpital Maisonneuve Rosemont

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 8 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: The Back; 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.	Other: The Back
Active Comparator: Chest; The probe is placed on the chest, 1 cm above the left nipple.	Other: Chest
Active Comparator: Left Axilla; The probe is placed deep in the left axilla	Other: Left Axilla

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The average temperature right axillary.	The average temperature axillary at the admission in the Neonatal intensive care unit.	1 year

Collaborators and Investigators

• Sponsor: Maisonneuve-Rosemont Hospital
• Investigators: Principal Investigator: Brahim Bensouda, MD, Maisonneuve-Rosemont Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: April 28, 2016
• First Submitted That Met QC Criteria: May 10, 2016
• First Posted (Estimate): May 11, 2016

Study Record Updates

• Last Update Posted (Actual): December 19, 2017
• Last Update Submitted That Met QC Criteria: December 15, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Temperature-Probe Placement-preterm infant-case room
• Additional Relevant MeSH Terms: Body Temperature Changes
• Other Study ID Numbers: 15052

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO