Temperature of Extremities and Necrotizing Enterocolitis

Necrotizing Enterocolitis Clinical Trial

Official title:

Association of Temperature of Extremities and Necrotizing Enterocolitis(NEC)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04801537
• Other study ID #: neutral temperature
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2022
• Source: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Contact: Chen Long, MD, PhD
• Phone: +8613883559467
• Email: neuroclong[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: January 1, 2024
• Gender: All
• Age group: 1 Hour to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Bloody Stool
• Enterocolitis
• Enterocolitis, Necrotizing
• Necrotizing Enterocolitis
• Neutral Temperature

Intervention

Other:
• normal body temperature and warm extremities
environmental temperature is set according to the standard method to keep normal body temperature and warm extremities
• normal body temperature and cold extremities
environmental temperature is set according to the standard method to keep normal body temperature, but cold extremities

Locations

Country	Name	City	State
China	Chen	Chongqing	Chongqing

Sponsors (2)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bloody stool	a infant is suffered from bloody stool	before discharge
Primary	necrotizing entercolitis(NEC)	a infant is suffered from NEC	before discharge
Secondary	late-onset sepsis(LOS)	a infant is suffered from LOS	before discharge