Temperature of Extremities and Necrotizing Enterocolitis

NCT04801537 | Unknown DMC

• 1 other identifier: neutral temperature
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Neutral Temperature; Bloody Stool; Necrotizing Enterocolitis

Outcome Measures

Primary Outcomes (2)

• bloody stool

  a infant is suffered from bloody stool

  before discharge

• necrotizing entercolitis(NEC)

  a infant is suffered from NEC

  before discharge

Secondary Outcomes (1)

• late-onset sepsis(LOS)

  before discharge

Study Arms (2)

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

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

Interventions

normal body temperature and warm extremities OTHER

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

normal body temperature and warm extremities

normal body temperature and cold extremities OTHER

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

normal body temperature and cold extremities

Eligibility Criteria

• Age: 1 Hour - 28 Days
• Sex: all
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• congenital deformities
• refusal of parents' consent

Sponsors & Collaborators

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

Study Sites (1)

Chen

Chongqing, Chongqing Municipality, 400014, China

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Hemorrhage; Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Enterocolitis; Gastroenteritis; Intestinal Diseases

Central Study Contacts

Chen Long, MD, PhD

CONTACT

+8613883559467; neuroclong@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 17, 2021
• Study Start: January 1, 2021
• Primary Completion: January 1, 2024
• Study Completion: December 31, 2024
• Last Updated: October 14, 2022

Record last verified: 2022-10

Locations

CN (1)