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NCT06275932
Management of Healthy Newborn's Body Temperature at Birth
NA trial testing Interventional group in Newborn, Infant in 776 participants. Status unknown.
1 April 2025
Quick facts
| Lead sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 776 |
| Start date | 1 April 2024 |
| Primary completion | 1 April 2025 |
| Estimated completion | 31 May 2025 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Interventional group
- Standard of care group
Conditions studied
- Newborn, Infant — all drugs for Newborn, Infant →
- Body Temperature — all drugs for Body Temperature →
- Delivery Room — all drugs for Delivery Room →
Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Who can join
Eligibility, any sex, with Newborn, Infant or Body Temperature. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06275932
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06275932 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Last refreshed: 23 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06275932.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing