NCT02769468

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 11, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 19, 2017

Status Verified

December 1, 2017

Enrollment Period

1.1 years

First QC Date

April 28, 2016

Last Update Submit

December 15, 2017

Conditions

Body Temperature Changes

Keywords

Temperature-Probe Placement-preterm infant-case room

Outcome Measures

Primary Outcomes (1)

  • The average temperature right axillary.

    The average temperature axillary at the admission in the Neonatal intensive care unit.

    1 year

Study Arms (3)

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.

Other: The Back

Chest

ACTIVE COMPARATOR

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

Other: Chest

Left Axilla

ACTIVE COMPARATOR

The probe is placed deep in the left axilla

Other: Left Axilla

Interventions

The BackOTHER
The Back
ChestOTHER
Chest
Left AxillaOTHER
Left Axilla

Eligibility Criteria

Age28 Weeks - 36 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Preterm infant with gestational age between 28 and 35 6/7 weeks

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Maisonneuve Rosemont

Montreal, Quebec, H1T2M4, Canada

Location

MeSH Terms

Conditions

Body Temperature Changes

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Brahim Bensouda, MD

    Maisonneuve-Rosemont Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD. Assistant Professor

Study Record Dates

First Submitted

April 28, 2016

First Posted

May 11, 2016

Study Start

November 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

December 19, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)