Clinical trial NCT06275932: Management of Healthy Newborn's Body Temperature at Birth
Official title: Management of Healthy Newborn's Body Temperature With the Use of Blanket: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Newborn, Infant
Body Temperature
Delivery Room
Keywords: newborn, infant
body temperature
delivery room
hypothermia, induced
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 776
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

For mother

* Mothers' age over 18 years and good comprehension of Italian language;
* Signed informed consent of the mother.

For newborn

* Informed consent signed by both parents, or in the case of a single-parent family, by mother
* Gestational age at birth greater than or equal to 37+0 weeks
* Newborns from singleton pregnancies;
* Both male and female newborns;
* Newborns who will be born from vaginal birth.

Exclusion Criteria:

For mother

* Mothers who do not want to carry out skin-to-skin contact;
* Mothers who do not understand/speak the Italian language;
* Mothers who need assistance procedures that hinder skin-to-skin contact.

For newborn

* Newborns whose parents decline participation in the study;
* Newborns with major congenital anomalies (heart, brain, metabolic, gastrointestinal);
* Newborns born via cesarean section;
* Newborns whose parents are under 18 years old, in the case of a single parent the mother who is under 18 years;
* Newborns requiring neonatal resuscitation after birth with obstruction of the skin-to-skin contact.

Primary outcomes:
measure: Newborn's body temperature at the end of skin-to-skin contact
timeFrame: At the beginning and the end skin-to-skin contact, up to three hours after birth.
Secondary outcomes:
measure: Newborns' proportion with a body temperature < 36.5°C when arriving at the nursery
timeFrame: At the arrival in the nursery, up to six hours after birth.
measure: Newborns' proportion with temperature below 36.0°C at the end of skin-to-skin contact and at arrival in the nursery
timeFrame: At the end of skin-to-skin contact and at arrival in the nursery, up to six hours after birth.
measure: Newborns' proportion with moderate hypothermia (temperature 36.0 - 36.4°C) at the end of skin-to-skin contact and at arrival in the nursery
timeFrame: At the end of skin-to-skin contact and at arrival in the nursery, up to six hours after birth.
measure: Newborns' proportion with hyperthermia (temperature > 37.5°C) at the end of skin-to-skin contact and at arrival in the nursery
timeFrame: At the end of skin-to-skin contact and at arrival in the nursery, up to six hours after birth.
measure: Newborns' average temperature one hour after arriving at the nursery
timeFrame: At arrival in the nursery, up to six hours after birth.
measure: Duration of nursery stay
timeFrame: from birth until discharge, measured up to 1 week.
measure: Duration of skin-to-skin contact
timeFrame: From the beginning until the end of skin-to-skin contact, up to three hours after birth.
measure: Newborns' proportion exclusively breastfed at discharge
timeFrame: At discharge from the nursery, measured up to 1 week.
measure: Type of breastfeeding at discharge
timeFrame: At discharge from the nursery, measured up to 1 week.
measure: Newborns' proportion with hypoglycemia during hospitalization
timeFrame: At discharge from the nursery, measured up to 1 week.
measure: Newborns' proportion affected by respiratory distress syndrome
timeFrame: At discharge from the nursery, measured up to 1 week.
measure: Newborns' proportion transferred to the Neonatal Intensive Care Unit (NICU)
timeFrame: At discharge from the nursery, measured up to 1 week.
measure: Newborns' weight loss at discharge
timeFrame: At discharge from the nursery, measured up to 1 week.
measure: Mortality before discharge from hospital
timeFrame: At discharge from the nursery, measured up to 1 week.
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Study officials:
affiliation: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
name: Gabriele Sorrentino, pedRN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sharma D. Golden hour of neonatal life: Need of the hour. Matern Health Neonatol Perinatol. 2017 Sep 19;3:16. doi: 10.1186/s40748-017-0057-x. eCollection 2017.
citation: Manani M, Jegatheesan P, DeSandre G, Song D, Showalter L, Govindaswami B. Elimination of admission hypothermia in preterm very low-birth-weight infants by standardization of delivery room management. Perm J. 2013 Summer;17(3):8-13. doi: 10.7812/TPP/12-130.
citation: Trevisanuto D, Testoni D, de Almeida MFB. Maintaining normothermia: Why and how? Semin Fetal Neonatal Med. 2018 Oct;23(5):333-339. doi: 10.1016/j.siny.2018.03.009. Epub 2018 Mar 21.
citation: World Health Organization. Thermal protection of the newborn: a practical guide. Published online 1997.
citation: Duryea EL, Nelson DB, Wyckoff MH, Grant EN, Tao W, Sadana N, Chalak LF, McIntire DD, Leveno KJ. The impact of ambient operating room temperature on neonatal and maternal hypothermia and associated morbidities: a randomized controlled trial. Am J Obstet Gynecol. 2016 Apr;214(4):505.e1-505.e7. doi: 10.1016/j.ajog.2016.01.190. Epub 2016 Feb 10.
citation: Moore ER, Anderson GC, Bergman N, Dowswell T. Early skin-to-skin contact for mothers and their healthy newborn infants. Cochrane Database Syst Rev. 2012 May 16;5(5):CD003519. doi: 10.1002/14651858.CD003519.pub3.