Clinical trial NCT02769468: Effect of Probe Placement in Delivery Room on Temperature at the Admission of Premature Infants?
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?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Temperature Changes
Keywords: Temperature-Probe Placement-preterm infant-case room
Lead sponsor: Maisonneuve-Rosemont Hospital
Sponsor class: OTHER
First posted: 2016-05-11
Enrollment: 121
Sex: ALL
Minimum age (years): 28
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The average temperature right axillary.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Hopital Maisonneuve Rosemont
state: Quebec
Study officials:
affiliation: Maisonneuve-Rosemont Hospital
name: Brahim Bensouda, MD
role: PRINCIPAL_INVESTIGATOR
References: