Neutral TemperatureNCT04801537
Temperature of Extremities and Necrotizing Enterocolitis
An observational study of Neutral Temperature and Bloody Stool, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial summary
Bloody stool and necrotizing enterocolitis(NEC) is two main focus in non-neonatal intensive care unit ward and usually lead to longed duration of hospitalization. Neutral temperature is a environmental temperature where the infant's body temperature is normal under resting state, and the changes of body temperature… Read more about this study
- Who is it for?
- Ages 1 hour to 28 days
- Conditions the study is for
- Neutral Temperature, Bloody Stool, Necrotizing Enterocolitis
- What is being tested?
- normal body temperature and warm extremities and normal body temperature and cold extremities
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2024
- Phase
- Observational
- 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 hour to 28 days
- All sexes
- Child
Study population: an infant's body weight > 2500 grams and/or gestational age >35 weeks is included in the present study.
Who may be able to join
- body weight >2500 grams and/or gestational age >35 weeks
- an infant is diagnosed with hyperbilirubinemia and/or pneumonia without need for oxygen inhalation
Who cannot join
- congenital deformities
- refusal of parents' consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chen
Chongqing, Chongqing Municipality, 400014
Chen Long, MD,PhD, +8613883559467, neuroclong@126.com
About this study
Official title: Association of Temperature of Extremities and Necrotizing Enterocolitis(NEC)
Bloody stool and necrotizing enterocolitis(NEC) is two main focus in non-neonatal intensive care unit ward and usually lead to longed duration of hospitalization.
Neutral temperature is a environmental temperature where the infant's body temperature is normal under resting state, and the changes of body temperature and skin temperature are less than 0.2-0.3 centigrade. According the definition, a suggested temperature range is set. For example, if an infant's body weight is more than 2500 gram, the initial set of environmental temperature is 31.3 centigrade with a range of 29.8-32.8 centigrade.
low environmental temperature is a risk factor for Bloody stool and NEC. Therefore, how to set the optimal environmental temperature is a challenge.
Read the detailed description
After birth, newborns must adapt to their relatively cold environment by the metabolic production of heat because they are not able to generate an adequate shivering response. Under the condition, environment temperature should be given to protect an infant from cold stress and cold injury, even NEC.
Therefore, the setting of the optimal environment temperature is a key focus in neonatal ward. Here, the investigators suggest a hypothesis that environment temperature should be set to keep warmth of extremities temperature and infant's body temperature is between 36.7-37.3 centigrade.
In the present study, the investigators will test the hypothesis.
- Conditions
- Neutral Temperature, Bloody Stool, Necrotizing Enterocolitis
- Being tested
- normal body temperature and warm extremities, normal body temperature and cold extremities
- Medical subject headings
- Gastrointestinal Hemorrhage, Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal body temperature and warm extremitiesOther
environmental temperature is set according to the standard method to keep normal body temperature and warm extremities
normal body temperature and cold extremitiesOther
environmental temperature is set according to the standard method to keep normal body temperature, but cold extremities
| Study group | Role | What they receive |
|---|---|---|
| normal body temperature and warm extremities | standard set of environmental temperature is done, and the infant's body temperature is normal and extremities are warm Receives: Other: normal body temperature and warm extremities | |
| normal body temperature and cold extremities | standard set of environmental temperature is done, and infant's body temperature is normal and extremities are cold Receives: Other: normal body temperature and cold extremities |
What is being measured
The primary outcome is the main question the study is designed to answer.
bloody stool
a infant is suffered from bloody stool
Measured: before discharge
necrotizing entercolitis(NEC)
a infant is suffered from NEC
Measured: before discharge
Secondary outcomes (1)
late-onset sepsis(LOS)
a infant is suffered from LOS
Measured: before discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start1 Jan 2021
- Primary completion1 Jan 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neutral TemperatureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Chongqing Medical University
- Responsible party
- Principal investigator, Chen Long,MD, Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801537
- Sponsor's protocol ID
- neutral temperature
- Status last verified
- Oct 2022
- First submitted
- 12 Mar 2021
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Temperature of Extremities and Necrotizing Enterocolitis(NEC)
- ClinicalTrials.gov ID
- NCT04801537
- Acronym / sponsor ID
- neutral temperature
- Conditions
- Neutral Temperature, Bloody Stool, Necrotizing Enterocolitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Collaborators
- Children's Hospital of Chongqing Medical University
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 17 Mar 2021 (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.
Bloody stool and necrotizing enterocolitis(NEC) is two main focus in non-neonatal intensive care unit ward and usually lead to longed duration of hospitalization.
Neutral temperature is a environmental temperature where the infant's body temperature is normal under resting state, and the changes of body temperature and skin temperature are less than 0.2-0.3 centigrade. According the definition, a suggested temperature range is set. For example, if an infant's body weight is more than 2500 gram, the initial set of environmental temperature is 31.3 centigrade with a range of 29.8-32.8 centigrade.
low environmental temperature is a risk factor for Bloody stool and NEC. Therefore, how to set the optimal environmental temperature is a challenge.
Detailed description
After birth, newborns must adapt to their relatively cold environment by the metabolic production of heat because they are not able to generate an adequate shivering response. Under the condition, environment temperature should be given to protect an infant from cold stress and cold injury, even NEC.
Therefore, the setting of the optimal environment temperature is a key focus in neonatal ward. Here, the investigators suggest a hypothesis that environment temperature should be set to keep warmth of extremities temperature and infant's body temperature is between 36.7-37.3 centigrade.
In the present study, the investigators will test the hypothesis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal body temperature and warm extremities | – | Other: normal body temperature and warm extremitiesstandard set of environmental temperature is done, and the infant's body temperature is normal and extremities are warm |
| normal body temperature and cold extremities | – | Other: normal body temperature and cold extremitiesstandard set of environmental temperature is done, and infant's body temperature is normal and extremities are cold |
Who may qualify
- Ages
- 1 hour to 28 days
- Sex
- All
- Age groups
- Child
- Study population
- an infant's body weight > 2500 grams and/or gestational age >35 weeks is included in the present study.
Key inclusion criteria (2 listed)
- body weight >2500 grams and/or gestational age >35 weeks
- an infant is diagnosed with hyperbilirubinemia and/or pneumonia without need for oxygen inhalation
Key exclusion criteria (2 listed)
- congenital deformities
- refusal of parents' consent
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 |
|---|---|---|
| normal body temperature and warm extremitiesenvironmental temperature is set according to the standard method to keep normal body temperature and warm extremities | Other | normal body temperature and warm extremities |
| normal body temperature and cold extremitiesenvironmental temperature is set according to the standard method to keep normal body temperature, but cold extremities | Other | normal body temperature and cold extremities |
Primary outcome
bloody stool
Time frame: before discharge
a infant is suffered from bloody stool
necrotizing entercolitis(NEC)
Time frame: before discharge
a infant is suffered from NEC
1 secondary outcome
late-onset sepsis(LOS)
Time frame: before discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neutral Temperature and Bloody Stool, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
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 2 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: status not confirmed, as of the sponsor's last update on 14 Oct 2022. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen Long, MD, PhD (+8613883559467, neuroclong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bloody stool (time frame: before discharge). The study lists 2 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 14 Oct 2022.