HypothermiaNCT05729698
Efficacy of A Novel in Prevention of Neonatal Hypothermia
A study testing Baby warmer swaddle and polyethylene bag in people with Hypothermia and Newborn, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The research was carried out to determine the effect of baby warmer swaddle, which has a heating system used after the birth of preterm babies, on the development of hypothermia. Read more about this study
- Who is it for?
- Ages 1 to 1 dayHealthy volunteers can take part
- Conditions the study is for
- Hypothermia, Newborn, Preterm Birth
- What is being tested?
- Baby warmer swaddle and polyethylene bag
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2020to 1 Jan 2023
- 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 day
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- between 32-37 GH,
- with an indication for hospitalization in the NICU,
- with a body temperature of 36.4 °C and above in the axillary route immediately after birth,
- with a maternal body temperature between 36.4 °C and 38 °C in the tympanic route are included in the study
Who cannot join
- with congenital anomalies,
- who were transported to another hospital, or who were transported to the hospital where the research was conducted from an external center
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpaşa
Istanbul, 34381
About this study
Official title: Efficacy of A Novel in Prevention of Neonatal Hypothermia in Preterm: Baby Warmer Swaddle
The research was carried out to determine the effect of baby warmer swaddle, which has a heating system used after the birth of preterm babies, on the development of hypothermia.
Design: Randomized controlled clinical trial Setting: The research was carried out in the NICU of a training and research hospital in Istanbul.
Method: A total of 65 babies between 32-37 weeks of gestation were included in the study. In accordance with the routine procedure of the clinic, preterm babies wrapped in polyethylene bags after birth formed the control group (n=33), while babies wrapped in polyethylene bags and placed in a swaddle with a heating system formed the experimental group (n=32).
Read the detailed description
Although neonatal hypothermia has higher rates especially in underdeveloped and developing countries, it is a global health problem also seen in developed countries. In a meta-analysis study, the prevalence of neonatal hypothermia was reported as 57.2% in East Africa. In a multicenter, prospective study, 79.6% of preterm newborns were admitted to NICUs with hypothermia in Ethiopia. In a study, the incidence of hypothermia to be 53% in the first 24 hours of life in preterm infants they conducted in a hospital in France. In a study, in 28 countries with upper-middle income status, admission temperature data of a total of 454,617 very low birth weight infants from 2009 to 2016 were analyzed. Although these data showed an improvement in hypothermia rates ranging from 52.6% (2009) to 38.2% (2016), approximately 4 out of 10 infants experienced hypothermia when admitted to the NICU. Similarly, in the United Kingdom, the National Neonatal Monitoring Program reported the prevalence of hypothermia as 28% and 25% for babies born in 2015 and 2016, respectively, emphasizing hypothermia as an ongoing problem.
- Conditions
- Hypothermia, Newborn, Preterm Birth
- Being tested
- Baby warmer swaddle, polyethylene bag
- Keywords
- hypothermia, newborn, body temperature changes, preterm birth
- Medical subject headings
- Hypothermia, Premature Birth, Body Temperature Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baby warmer swaddleDevice
Also called prethermo
Baby Swaddle with Heating System
polyethylene bagOther
polyethylene food bag
| Study group | Role | What they receive |
|---|---|---|
| polyethylene bag method | Experimental | polyethylene bag method: preterm babies will be placed in polythene bags after birth Receives: Other: polyethylene bag |
| baby warmer swaddle method | Experimental | baby warmer swaddle group: preterm babies will be placed in baby warmer swaddle after birth Receives: Device: Baby warmer swaddle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal hypothermia
Neonatal hypothermia is defined as temperature < 36.5C
Measured: immediately after birth
Neonatal hypothermia
Neonatal hypothermia is defined as temperature < 36.5C
Measured: 20 minutes after birth
Neonatal hypothermia
Neonatal hypothermia is defined as temperature < 36.5C
Measured: 40 minutes after birth
Neonatal hypothermia
Neonatal hypothermia is defined as temperature < 36.5C
Measured: 60 minutes after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start1 Dec 2020
- Primary completion1 Dec 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothermiaStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Caglar, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729698
- Sponsor's protocol ID
- Sedacaglar
- Status last verified
- Feb 2023
- First submitted
- 16 Jan 2023
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of A Novel in Prevention of Neonatal Hypothermia in Preterm: Baby Warmer Swaddle
- ClinicalTrials.gov ID
- NCT05729698
- Acronym / sponsor ID
- Sedacaglar
- Conditions
- Hypothermia, Newborn, Preterm Birth
- Keywords
- hypothermia, newborn, body temperature changes, preterm birth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 15 Feb 2023 (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.
The research was carried out to determine the effect of baby warmer swaddle, which has a heating system used after the birth of preterm babies, on the development of hypothermia.
Design: Randomized controlled clinical trial Setting: The research was carried out in the NICU of a training and research hospital in Istanbul.
Method: A total of 65 babies between 32-37 weeks of gestation were included in the study. In accordance with the routine procedure of the clinic, preterm babies wrapped in polyethylene bags after birth formed the control group (n=33), while babies wrapped in polyethylene bags and placed in a swaddle with a heating system formed the experimental group (n=32).
Detailed description
Although neonatal hypothermia has higher rates especially in underdeveloped and developing countries, it is a global health problem also seen in developed countries. In a meta-analysis study, the prevalence of neonatal hypothermia was reported as 57.2% in East Africa. In a multicenter, prospective study, 79.6% of preterm newborns were admitted to NICUs with hypothermia in Ethiopia. In a study, the incidence of hypothermia to be 53% in the first 24 hours of life in preterm infants they conducted in a hospital in France. In a study, in 28 countries with upper-middle income status, admission temperature data of a total of 454,617 very low birth weight infants from 2009 to 2016 were analyzed. Although these data showed an improvement in hypothermia rates ranging from 52.6% (2009) to 38.2% (2016), approximately 4 out of 10 infants experienced hypothermia when admitted to the NICU. Similarly, in the United Kingdom, the National Neonatal Monitoring Program reported the prevalence of hypothermia as 28% and 25% for babies born in 2015 and 2016, respectively, emphasizing hypothermia as an ongoing problem.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| polyethylene bag method | Experimental | Other: polyethylene bagpolyethylene bag method: preterm babies will be placed in polythene bags after birth |
| baby warmer swaddle method | Experimental | Device: Baby warmer swaddlebaby warmer swaddle group: preterm babies will be placed in baby warmer swaddle after birth |
Who may qualify
- Ages
- 1 to 1 day
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- between 32-37 GH,
- with an indication for hospitalization in the NICU,
- with a body temperature of 36.4 °C and above in the axillary route immediately after birth,
- with a maternal body temperature between 36.4 °C and 38 °C in the tympanic route are included in the study
Key exclusion criteria (2 listed)
- with congenital anomalies,
- who were transported to another hospital, or who were transported to the hospital where the research was conducted from an external center
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 |
|---|---|---|
| Baby warmer swaddleAlso: prethermoBaby Swaddle with Heating System | Device | baby warmer swaddle method |
| polyethylene bagpolyethylene food bag | Other | polyethylene bag method |
Primary outcome
Neonatal hypothermia
Time frame: immediately after birth
Neonatal hypothermia is defined as temperature < 36.5C
Neonatal hypothermia
Time frame: 20 minutes after birth
Neonatal hypothermia is defined as temperature < 36.5C
Neonatal hypothermia
Time frame: 40 minutes after birth
Neonatal hypothermia is defined as temperature < 36.5C
Neonatal hypothermia
Time frame: 60 minutes after birth
Neonatal hypothermia is defined as temperature < 36.5C
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 15 Feb 2023.
- 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.
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 testing Baby warmer swaddle and polyethylene bag in people with Hypothermia and Newborn, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 4 inclusion and 2 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 15 Feb 2023. 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 Turkey (Türkiye). 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?
Neonatal hypothermia (time frame: immediately after birth). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2023.