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Temperature of Extremities and Necrotizing Enterocolitis

Association of Temperature of Extremities and Necrotizing Enterocolitis(NEC)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04801537
Enrollment
200
Registered
2021-03-17
Start date
2021-01-01
Completion date
2024-12-31
Last updated
2022-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bloody Stool, Necrotizing Enterocolitis, Neutral Temperature

Brief 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 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.

Interventions

OTHERnormal body temperature and warm extremities

environmental temperature is set according to the standard method to keep normal body temperature and warm extremities

OTHERnormal body temperature and cold extremities

environmental temperature is set according to the standard method to keep normal body temperature, but cold extremities

Sponsors

Children's Hospital of Chongqing Medical University
CollaboratorOTHER
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Hours to 28 Days

Inclusion criteria

* body weight \>2500 grams and/or gestational age \>35 weeks * an infant is diagnosed with hyperbilirubinemia and/or pneumonia without need for oxygen inhalation

Exclusion criteria

* congenital deformities * refusal of parents' consent

Design outcomes

Primary

MeasureTime frameDescription
bloody stoolbefore dischargea infant is suffered from bloody stool
necrotizing entercolitis(NEC)before dischargea infant is suffered from NEC

Secondary

MeasureTime frameDescription
late-onset sepsis(LOS)before dischargea infant is suffered from LOS

Countries

China

Contacts

Primary ContactChen Long, MD, PhD
neuroclong@126.com+8613883559467

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026