Newborn, InfantNCT06275932
Management of Healthy Newborn's Body Temperature at Birth
A study testing Interventional group in people with Newborn, Infant and Body Temperature, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Newborn, Infant, Body Temperature, Delivery Room
- What is being tested?
- Interventional group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- 30 Apr 2025to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Newborns from singleton pregnancies;
- Both male and female newborns;
- Newborns who will be born from vaginal birth.
Who cannot join
- 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;
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
About this study
Official title: Management of Healthy Newborn's Body Temperature With the Use of Blanket: Randomized Controlled Trial
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).
Read more
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.
Read the 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.
- Conditions
- Newborn, Infant, Body Temperature, Delivery Room
- Being tested
- Interventional group, Standard of care group
- Keywords
- newborn, infant, body temperature, delivery room, hypothermia, induced
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventional groupOther
Newborns will be covered with a thermal blanket during skin-to-skin contact in delivery room.
Standard of care groupOther
Newborns will be covered with a bed wetting mat and cotton sheet during skin-to-skin contact in delivery room.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | All the enrolled newborns will make the skin-to-skin contact with the use of a thermal blanket after birth. Receives: 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. Receives: Other: Standard of care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Evaluation of newborns' proportion with a body temperature < 36.5°C will be calculated in both arms of study measuring newborn's body temperature with a digital thermometer placed in axillary location when they will arrive at the nursery.
Measured: 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
Evaluation of newborns' proportion with temperature below 36.0°C at the end of skin-to-skin contact and at arrival in the nursery, in variation of the time spent in the delivery room at the end of the skin-to-skin contact, will be calculated in both arms of study measuring newborn's body temperature with a digital thermometer placed in axillary location.
Measured: 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
Evaluation of 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, in variation of the time spent in the delivery room at the end of the skin-to-skin contact, will be calculated in both arms of study measuring newborn's body temperature with a digital thermometer placed in axillary location.
Measured: 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
Evaluation of newborns' proportion with hyperthermia (temperature > 37.5°C) at the end of skin-to-skin contact and at arrival in the nursery, in variation of the time spent in the delivery room at the end of the skin-to-skin contact, will be calculated in both arms of study measuring newborn's body temperature with a digital thermometer placed in axillary location.
Measured: 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
Evaluation of newborns' average temperature one hour after arriving at the nursery will be calculated in both arms of study measuring newborn's body temperature with a digital thermometer placed in axillary location.
Measured: At arrival in the nursery, up to six hours after birth.
Duration of nursery stay
Duration of stay in the nursery (hours) will be collected from electronical medical records
Measured: from birth until discharge, measured up to 1 week.
Duration of skin-to-skin contact
Duration of skin-to-skin contact (minutes) will be collected from electronical medical records
Measured: From the beginning until the end of skin-to-skin contact, up to three hours after birth.
Newborns' proportion exclusively breastfed at discharge
Evaluation of Newborns' proportion exclusively breastfed at discharge will be collected from electronical medical records
Measured: At discharge from the nursery, measured up to 1 week.
Type of breastfeeding at discharge
Evaluation of the type of breastfeeding at discharge will be collected from electronical medical records.
Measured: At discharge from the nursery, measured up to 1 week.
Newborns' proportion with hypoglycemia during hospitalization
Evaluation of newborns' proportion with hypoglycemia during hospitalization will be collected from electronical medical records
Measured: At discharge from the nursery, measured up to 1 week.
Newborns' proportion affected by respiratory distress syndrome
Evaluation of newborns' proportion affected by respiratory distress syndrome will be collected from electronical medical records.
Measured: At discharge from the nursery, measured up to 1 week.
Newborns' proportion transferred to the Neonatal Intensive Care Unit (NICU)
Evaluation of newborns' proportion transferred to the NICU will be collected from electronical medical records.
Measured: At discharge from the nursery, measured up to 1 week.
Newborns' weight loss at discharge
Percentage of Newborns' weight loss at discharge will be collected from electronical medical records.
Measured: At discharge from the nursery, measured up to 1 week.
Mortality before discharge from hospital
Evaluation of mortality before discharge from hospital will be collected from electronical medical records.
Measured: At discharge from the nursery, measured up to 1 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start30 Apr 2025
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Why it stopped: Lack of acquisition of blankets
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Newborn, InfantStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriele Sorrentino, pedRN, Principal investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06275932
- Sponsor's protocol ID
- TermoNeo/2023
- Status last verified
- Jun 2026
- First submitted
- 6 Feb 2024
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28932408Manani 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.
PubMed 24355884Trevisanuto 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.
PubMed 29599071World Health Organization. Thermal protection of the newborn: a practical guide. Published online 1997.
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.
PubMed 26874298Moore 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.
PubMed 22592691
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Healthy Newborn's Body Temperature With the Use of Blanket: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06275932
- Acronym / sponsor ID
- TermoNeo/2023
- Conditions
- Newborn, Infant, Body Temperature, Delivery Room
- Keywords
- newborn, infant, body temperature, delivery room, hypothermia, induced
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of acquisition of blankets
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Other: Interventional groupAll the enrolled newborns will make the skin-to-skin contact with the use of a thermal blanket after birth. |
| Standard of care group | Active comparator | Other: Standard of care groupAll the enrolled newborns will make the skin-to-skin contact according to local procedure after birth. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interventional groupNewborns will be covered with a thermal blanket during skin-to-skin contact in delivery room. | Other | Interventional group |
| Standard of care groupNewborns will be covered with a bed wetting mat and cotton sheet during skin-to-skin contact in delivery room. | Other | Standard of care group |
Primary outcome
Newborn's body temperature at the end of skin-to-skin contact
Time frame: At the beginning and the end skin-to-skin contact, up to three hours after birth.
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.
14 secondary outcomes
Newborns' proportion with a body temperature < 36.5°C when arriving at the nursery
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At arrival in the nursery, up to six hours after birth.
Duration of nursery stay
Time frame: from birth until discharge, measured up to 1 week.
Duration of skin-to-skin contact
Time frame: From the beginning until the end of skin-to-skin contact, up to three hours after birth.
Newborns' proportion exclusively breastfed at discharge
Time frame: At discharge from the nursery, measured up to 1 week.
Type of breastfeeding at discharge
Time frame: At discharge from the nursery, measured up to 1 week.
Newborns' proportion with hypoglycemia during hospitalization
Time frame: At discharge from the nursery, measured up to 1 week.
Newborns' proportion affected by respiratory distress syndrome
Time frame: At discharge from the nursery, measured up to 1 week.
Newborns' proportion transferred to the Neonatal Intensive Care Unit (NICU)
Time frame: At discharge from the nursery, measured up to 1 week.
Newborns' weight loss at discharge
Time frame: At discharge from the nursery, measured up to 1 week.
Mortality before discharge from hospital
Time frame: At discharge from the nursery, measured up to 1 week.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Background: PubMed 28932408Sharma 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.
- Background: PubMed 24355884Manani 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.
- Background: PubMed 29599071Trevisanuto 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.
- BackgroundWorld Health Organization. Thermal protection of the newborn: a practical guide. Published online 1997.
- Background: PubMed 26874298Duryea 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.
- Background: PubMed 22592691Moore 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.
- WHO Recommendations on Postnatal Care of the Mother and Newborn. World Health OrganizationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriele Sorrentino, pedRN principal investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interventional group in people with Newborn, Infant and Body Temperature, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Newborn's body temperature at the end of skin-to-skin contact (time frame: At the beginning and the end skin-to-skin contact, up to three hours after birth.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06275932, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.