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

NCT ID: NCT02769468

Last Updated: 2017-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-12-31

Brief Summary

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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

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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

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Body Temperature Changes

Keywords

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Temperature-Probe Placement-preterm infant-case room

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

The Back

Intervention Type OTHER

Chest

The probe is placed on the chest, 1 cm above the left nipple.

Group Type ACTIVE_COMPARATOR

Chest

Intervention Type OTHER

Left Axilla

The probe is placed deep in the left axilla

Group Type ACTIVE_COMPARATOR

Left Axilla

Intervention Type OTHER

Interventions

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The Back

Intervention Type OTHER

Chest

Intervention Type OTHER

Left Axilla

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

28 Weeks

Maximum Eligible Age

36 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maisonneuve-Rosemont Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr Brahim Bensouda

MD. Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brahim Bensouda, MD

Role: PRINCIPAL_INVESTIGATOR

Maisonneuve-Rosemont Hospital

Locations

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Hopital Maisonneuve Rosemont

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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15052

Identifier Type: -

Identifier Source: org_study_id