Management of Healthy Newborn's Body Temperature at Birth

Body Temperature Clinical Trial

Official title: Management of Healthy Newborn's Body Temperature With the Use of Blanket: Randomized Controlled Trial

Status Not yet recruiting

Clinical Trial Summary

At birth, the newborn begins a process of adaptation to extrauterine life. One of the phases of this stabilization process is the maintenance of body temperature; indeed, the newborn passes from a warm environment (mother's womb) of around 37°C to an environment with a temperature lower (delivery room) and, therefore, must implement a series of physiological processes to be able to maintain body temperature constant and within ideal ranges through a balance between production and heat loss.

Hypothermia at birth could cause risks or comorbidities such as an increased risk of infant mortality, hypoglycemia, sepsis, metabolic acidosis, respiratory distress syndrome (RDS) and intraventricular hemorrhage (IVH).

One of the factors that affects heat loss in the delivery room is the relationship between surface area, volume and body mass of the newborn. The decrease in body temperature is directly related to gestational age and weight at birth; indeed, this problem is much more present in premature and/or low weight newborns at birth. Even if a full-term newborn has a more developed thermoregulation center than a preterm newborn, this does not mean that this type of newborns is not at risk heat dispersion.

To date, the strategies that are implemented for the physiological newborn are documented in the literature are, in addition to the heat chain described by the World Health Organization (WHO), the implementation of skin-to-skin contact (skin to skin) mother-newborn.

Some studies demonstrating the beneficial effect of this procedure on maintenance of the newborn's body temperature.

The aim of this study is to evaluate two healthcare interventions to prevent heat loss of healthy newborns at birth.

Clinical Trial Description

This study is a prospective, randomized controlled trial design which involves the use of two care interventions (experimental vs standard of care) to prevent heat loss of healthy newborns in the delivery room during contact skin to skin after birth.

Study population includes newborns born by natural birth with a gestational age greater than or equal to 37+0 weeks.

Newborns will be randomly assigned to receive: 1) a thermal blanket (experimental group) , or 2) a bed wetting mat and cotton sheet (standard of care group) that cover them during the skin-to-skin contact after birth.

At birth all newborns will receive the same care required by local procedures.

Research hypothesis:

• the use of a thermal blanket placed on the newborn during the skin-to-skin contact could reduce heat dispersion at the end of the procedure and therefore reduce the percentage of newborns who at the end of skin-to-skin contact have a temperature lower than 36.5°C.

The effectiveness of these interventions will be evaluated by measuring mother and newborn's body temperature at the beginning and the end of skin-to-skin contact. ;

Related Conditions & MeSH terms

• Body Temperature

• NCT number: NCT06275932
• Study type: Interventional
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: Gabriele Sorrentino, pedRN
• Phone: +393496060149
• Email: gabriele.sorrentino@policlinico.mi.it
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Completion date: May 31, 2025