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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?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02769468
Enrollment
121
Registered
2016-05-11
Start date
2015-11-30
Completion date
2016-12-31
Last updated
2017-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body Temperature Changes

Keywords

Temperature-Probe Placement-preterm infant-case room

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.

Interventions

OTHERThe Back
OTHERChest
OTHERLeft Axilla

Sponsors

Maisonneuve-Rosemont Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
28 Weeks to 36 Weeks
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The average temperature right axillary.1 yearThe average temperature axillary at the admission in the Neonatal intensive care unit.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026