Neonatal HypothermiaSCOPRINCT03844204
Effect of a Servo-control System on Heat Loss in Very Low Birth Weight Infants at Birth
A study of Neonatal Hypothermia, run by University Hospital Padova at 1 site in Italy.
Trial summary
Hypothermia in preterm infants during the immediate postnatal phase is associated with morbidity and mortality and remains an unresolved, worldwide challenge. A list of interventions, including adequate room temperature, use of infant warmers, polyethylene bags/wrap, pre-heated mattresses, caps and heated and… Read more about this study
- Who is it for?
- Ages 1 to 1 minute
- Conditions the study is for
- Neonatal Hypothermia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2019to 29 Feb 2020
- 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 1 to 1 minute
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Estimated birth weight <1500 g and/or gestational age <30+6 weeks (and)
- Inborn (and)
- Parental consent
Who cannot join
- Major congenital malformations (i.e. cardiac disease, defects of abdominal wall, ...);
- Outborn;
- Parental refusal to participate to the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Servo-control System on Heat Loss in Very Low Birth Weight Infants at Birth: a Multicenter, Prospective, Randomized Controlled Trial
Hypothermia in preterm infants during the immediate postnatal phase is associated with morbidity and mortality and remains an unresolved, worldwide challenge.
A list of interventions, including adequate room temperature, use of infant warmers, polyethylene bags/wrap, pre-heated mattresses, caps and heated and humidified gases, to prevent thermal loss at birth in very preterm infants has been recommended, but a certain percentage of very preterm infants are hypothermic at the time of the neonatal intensive care unit (NICU) admission suggesting that further measures are needed. The thermal servo-controlled systems are routinely used in the NICU to accurately manage the patients' temperature, but their role during the immediate postnatal phase has not been previously assessed.
We hypothesized that using a thermal servo-control system at delivery could prevent heat loss during this delicate phase and increase the percentage of very low birth weight infants (VLBWI) in the normal thermal range (temperature 36.5-37.5°C) at NICU admission. The aim of this study will be to compare two modes of thermal management (with and without the use of a thermal servo-controlled system) for preventing heat loss at birth in VLBWI infants.
- Conditions
- Neonatal Hypothermia
- Being tested
- Thermal servo-controlled system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal servo-controlled systemDevice
All patients will be positioned under the infant warmer. In the treatment group, a probe positioned on the skin of the neonate will guide the thermal exposure in a servo-controlled modality. In the control group, thermal exposure will be determined manually by setting the power of the heater at the maximum output.
| Study group | Role | What they receive |
|---|---|---|
| Servo-controlled system | Experimental | The temperature probe of the servo-controlled system will be positioned on the patient's abdomen with an adhesive tape. The body temperature will be set at 37°C. Receives: Device: Thermal servo-controlled system |
| No servo-controlled system | Active comparator | The temperature of the infant warmer will be manually set at maximum of power output. Receives: Device: Thermal servo-controlled system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of neonates in the normal thermal range (temperature 36.5-37.5°C) at NICU admission
Measured: 30 minutes
Secondary outcomes (9)
Proportion of neonates with temperature less than 36.0°C at NICU admission
Measured: 30 minutes
Proportion of neonates with mild hypothermia (temperature 36.0-36.4°C) at NICU admission
Measured: 30 minutes
Proportion of hyperthermic neonates (temperature >38.0°C) at NICU admission
Measured: 30 minutes
Temperature at 1 hour after NICU admission
Measured: 1 hour
Proportion of ineonates with ntraventricular hemorrhage (grade I-IV)
Measured: 7 days
Propoertions of neoantes with respiratory distress syndrome
Measured: 3 days
Proportion of neonates with late onset sepsis
Measured: 14 days
Proportion of neonates with bronchopulmonary dysplasia
Measured: 36 gestational weeks
Proportion of deaths
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start1 Mar 2019
- Primary completion29 Feb 2020
- Study completion29 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal HypothermiaStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniele Trevisanuto, University Hospital Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844204
- Sponsor's protocol ID
- 4371/AO
- Acronym
- SCOPRI
- Status last verified
- Apr 2020
- First submitted
- 14 Feb 2019
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cavallin F, Doglioni N, Allodi A, Battajon N, Vedovato S, Capasso L, Gitto E, Laforgia N, Paviotti G, Capretti MG, Gizzi C, Villani PE, Biban P, Pratesi S, Lista G, Ciralli F, Soffiati M, Staffler A, Baraldi E, Trevisanuto D; Servo COntrol for PReterm Infants (SCOPRI) Trial Group. Thermal management with and without servo-controlled system in preterm infants immediately after birth: a multicentre, randomised controlled study. Arch Dis Child Fetal Neonatal Ed. 2021 Nov;106(6):572-577. doi: 10.1136/archdischild-2020-320567. Epub 2021 Feb 17.
PubMed 33597230
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Servo-control System on Heat Loss in Very Low Birth Weight Infants at Birth: a Multicenter, Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03844204
- Acronym / sponsor ID
- SCOPRI / 4371/AO
- Conditions
- Neonatal Hypothermia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- University Hospital PadovaUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 18 Feb 2019 (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.
Hypothermia in preterm infants during the immediate postnatal phase is associated with morbidity and mortality and remains an unresolved, worldwide challenge.
A list of interventions, including adequate room temperature, use of infant warmers, polyethylene bags/wrap, pre-heated mattresses, caps and heated and humidified gases, to prevent thermal loss at birth in very preterm infants has been recommended, but a certain percentage of very preterm infants are hypothermic at the time of the neonatal intensive care unit (NICU) admission suggesting that further measures are needed. The thermal servo-controlled systems are routinely used in the NICU to accurately manage the patients' temperature, but their role during the immediate postnatal phase has not been previously assessed.
We hypothesized that using a thermal servo-control system at delivery could prevent heat loss during this delicate phase and increase the percentage of very low birth weight infants (VLBWI) in the normal thermal range (temperature 36.5-37.5°C) at NICU admission. The aim of this study will be to compare two modes of thermal management (with and without the use of a thermal servo-controlled system) for preventing heat loss at birth in VLBWI infants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Servo-controlled system | Experimental | Device: Thermal servo-controlled systemThe temperature probe of the servo-controlled system will be positioned on the patient's abdomen with an adhesive tape. The body temperature will be set at 37°C. |
| No servo-controlled system | Active comparator | Device: Thermal servo-controlled systemThe temperature of the infant warmer will be manually set at maximum of power output. |
Who may qualify
- Ages
- 1 to 1 minute
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Estimated birth weight <1500 g and/or gestational age <30+6 weeks (and)
- Inborn (and)
- Parental consent
Key exclusion criteria (3 listed)
- Major congenital malformations (i.e. cardiac disease, defects of abdominal wall, ...);
- Outborn;
- Parental refusal to participate to the study.
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 |
|---|---|---|
| Thermal servo-controlled systemAll patients will be positioned under the infant warmer. In the treatment group, a probe positioned on the skin of the neonate will guide the thermal exposure in a servo-controlled modality. In the control group, thermal exposure will be determined manually by setting the power of the heater at the maximum output. | Device | No servo-controlled system, Servo-controlled system |
Primary outcome
Proportion of neonates in the normal thermal range (temperature 36.5-37.5°C) at NICU admission
Time frame: 30 minutes
9 secondary outcomes
Proportion of neonates with temperature less than 36.0°C at NICU admission
Time frame: 30 minutes
Proportion of neonates with mild hypothermia (temperature 36.0-36.4°C) at NICU admission
Time frame: 30 minutes
Proportion of hyperthermic neonates (temperature >38.0°C) at NICU admission
Time frame: 30 minutes
Temperature at 1 hour after NICU admission
Time frame: 1 hour
Proportion of ineonates with ntraventricular hemorrhage (grade I-IV)
Time frame: 7 days
Propoertions of neoantes with respiratory distress syndrome
Time frame: 3 days
Proportion of neonates with late onset sepsis
Time frame: 14 days
Proportion of neonates with bronchopulmonary dysplasia
Time frame: 36 gestational weeks
Proportion of deaths
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Derived from this study: PubMed 33597230Cavallin F, Doglioni N, Allodi A, Battajon N, Vedovato S, Capasso L, Gitto E, Laforgia N, Paviotti G, Capretti MG, Gizzi C, Villani PE, Biban P, Pratesi S, Lista G, Ciralli F, Soffiati M, Staffler A, Baraldi E, Trevisanuto D; Servo COntrol for PReterm Infants (SCOPRI) Trial Group. Thermal management with and without servo-controlled system in preterm infants immediately after birth: a multicentre, randomised controlled study. Arch Dis Child Fetal Neonatal Ed. 2021 Nov;106(6):572-577. doi: 10.1136/archdischild-2020-320567. Epub 2021 Feb 17.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Neonatal Hypothermia, run by University Hospital Padova 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 3 Apr 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of neonates in the normal thermal range (temperature 36.5-37.5°C) at NICU admission (time frame: 30 minutes). 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 NCT03844204, which also lists 1 linked publication.
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 3 Apr 2020.