Management of Healthy Newborn's Body Temperature at Birth

NCT06275932 | Not Yet Recruiting

• 1 other identifier: TermoNeo/2023
• Study Type: interventional
• Target: 776
• Locations: 1 country
• Sites: 1

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.

Conditions

Newborn, Infant; Body Temperature; Delivery Room

Keywords

newborn, infant; body temperature; delivery room; hypothermia, induced

Outcome Measures

Primary Outcomes (1)

• Newborn's body temperature at the end of skin-to-skin contact

  Newborn's body temperature will be measured at the beginning and the end of skin-to-skin contact with a digital thermometer placed in axillary location. Newborn's body temperature at the end of kin-to-skin contact will be compared between two groups.

  At the beginning and the end skin-to-skin contact, up to three hours after birth.

Secondary Outcomes (14)

• Newborns' proportion with a body temperature < 36.5°C when arriving at the nursery

  At the arrival in the nursery, up to six hours after birth.

• Newborns' proportion with temperature below 36.0°C at the end of skin-to-skin contact and at arrival in the nursery

  At the end of skin-to-skin contact and at arrival in the nursery, up to six hours after birth.

• 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

  At the end of skin-to-skin contact and at arrival in the nursery, up to six hours after birth.

• Newborns' proportion with hyperthermia (temperature > 37.5°C) at the end of skin-to-skin contact and at arrival in the nursery

  At the end of skin-to-skin contact and at arrival in the nursery, up to six hours after birth.

• Newborns' average temperature one hour after arriving at the nursery

  At arrival in the nursery, up to six hours after birth.

Study Arms (2)

Interventional group

EXPERIMENTAL

All the enrolled newborns will make the skin-to-skin contact with the use of a thermal blanket after birth.

Other: Interventional group

Standard of care group

ACTIVE COMPARATOR

All the enrolled newborns will make the skin-to-skin contact according to local procedure after birth.

Other: Standard of care group

Interventions

Interventional group OTHER

Newborns will be covered with a thermal blanket during skin-to-skin contact in delivery room.

Interventional group

Standard of care group OTHER

Newborns will be covered with a bed wetting mat and cotton sheet during skin-to-skin contact in delivery room.

Standard of care group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Related Publications (6)

• 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.

  PMID: 28932408 BACKGROUND

• 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.

  PMID: 24355884 BACKGROUND

• 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.

  PMID: 29599071 BACKGROUND

• World Health Organization. Thermal protection of the newborn: a practical guide. Published online 1997.

  BACKGROUND

• 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.

  PMID: 26874298 BACKGROUND

• 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.

  PMID: 22592691 BACKGROUND

Related Links

• WHO Recommendations on Postnatal Care of the Mother and Newborn. World Health Organization

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gabriele Sorrentino, pedRN

  Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriele Sorrentino, pedRN

CONTACT

+393496060149; gabriele.sorrentino@policlinico.mi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 23, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: May 31, 2025
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)