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

Body Temperature Changes Clinical Trial

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02769468
• Other study ID #: 15052
• Status: Completed
• Phase: N/A
• First received: April 28, 2016
• Last updated: December 15, 2017
• Start date: November 2015
• Est. completion date: December 2016

Study information

• Verified date: December 2017
• Source: Maisonneuve-Rosemont Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Weeks to 36 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Body Temperature Changes

Intervention

Other:
• The Back

• Chest

• Left Axilla

Locations

Country	Name	City	State
Canada	Hopital Maisonneuve Rosemont	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Maisonneuve-Rosemont Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The average temperature right axillary.	The average temperature axillary at the admission in the Neonatal intensive care unit.	1 year