Temperature of Extremities and Necrotizing Enterocolitis

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.

Study Overview

• Status: Recruiting
• Conditions: Necrotizing Enterocolitis; Bloody Stool; Neutral Temperature
• Intervention / Treatment: Other: normal body temperature and warm extremities; Other: normal body temperature and cold extremities

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400014
      • Recruiting
      • Chen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 4 weeks (CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

an infant's body weight > 2500 grams and/or gestational age >35 weeks is included in the present study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	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; standard set of environmental temperature is done, and infant's body temperature is normal and extremities are cold	Other: normal body temperature and cold extremities; environmental temperature is set according to the standard method to keep normal body temperature, but cold extremities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bloody stool	a infant is suffered from bloody stool	before discharge
necrotizing entercolitis(NEC)	a infant is suffered from NEC	before discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
late-onset sepsis(LOS)	a infant is suffered from LOS	before discharge

Collaborators and Investigators

• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Collaborators: Children's Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2021
• Primary Completion (ANTICIPATED): January 1, 2024
• Study Completion (ANTICIPATED): December 31, 2024

Study Registration Dates

• First Submitted: March 12, 2021
• First Submitted That Met QC Criteria: March 12, 2021
• First Posted (ACTUAL): March 17, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 14, 2022
• Last Update Submitted That Met QC Criteria: October 13, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Enterocolitis; Enterocolitis, Necrotizing
• Other Study ID Numbers: neutral temperature

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No