Temperature of Extremities and Necrotizing Enterocolitis

Army Medical University of People's Liberation Army

Status: Enrolling

Conditions: Necrotizing Enterocolitis; Bloody Stool; Neutral Temperature

Treatments: Other: normal body temperature and cold extremities; Other: normal body temperature and warm extremities

Study type: Observational

Funder types: Other

Identifiers

NCT04801537

neutral temperature

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 1 hour to 28 days old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

normal body temperature and warm extremities

Description:

standard set of environmental temperature is done, and the infant's body temperature is normal and extremities are warm

Treatment:

Other: normal body temperature and warm extremities

normal body temperature and cold extremities

Description:

standard set of environmental temperature is done, and infant's body temperature is normal and extremities are cold

Treatment:

Other: normal body temperature and cold extremities