Temperature of Extremities and Necrotizing Enterocolitis

Recruiting

• Conditions: Neutral Temperature; Bloody Stool; Necrotizing Enterocolitis
• Interventions: Other: normal body temperature and cold extremities; Other: normal body temperature and warm extremities

• Registration Number: NCT04801537
• Lead Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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.

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-03-12
• Study First Submitted QC: 2021-03-12
• Study First Posted: 2021-03-17
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-13
• Last Update Posted: 2022-10-14
• Primary Completion: 2024-01-01
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
normal body temperature and cold 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
normal body temperature and warm extremities	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

Primary Outcome Measures

Name	Time	Method
necrotizing entercolitis(NEC)	before discharge	a infant is suffered from NEC
bloody stool	before discharge	a infant is suffered from bloody stool

Secondary Outcome Measures

Name	Time	Method
late-onset sepsis(LOS)	before discharge	a infant is suffered from LOS

Trial Locations

Locations (1)

Chen; 🇨🇳 Chongqing, Chongqing, China