Milk Temperature Control and Necrotizing Enterocolitis Risk in Extremely Preterm Infants

Necrotizing enterocolitis (NEC) is one of the most common and severe gastrointestinal emergencies during the neonatal period, especially among preterm infants. In high-income countries such as Finland and the USA, the prevalence of NEC ranges from 2% to 16.58% among very preterm infants (VPIs) and from 6.8% to 10.0% among extremely preterm infants (EPIs). According to the 2022 Annual Report of the China Newborn Collaboration Network (CHNN) from 89 tertiary hospitals, the prevalence of NEC was reported at 14.2% among VPIs and EPIs. Up to half of NEC cases in infants require surgical intervention, with 39.1% of VPIs and 44.5% of EPIs needing surgery. Consequently, NEC-related mortality rates vary significantly, ranging from 21.9% to 42.3% in preterm infants weighing less than 1500 grams (equivalent to VPIs) and from 33.0% to 50.5% in those weighing 500-1000 grams (equivalent to EPIs).

NCT Number	NCT06908239
Lead Sponsor	Daping Hospital and the Research Institute of Surgery of the Third Military Medical University Collaborators: Children's Hospital of Chongqing Medical University, children and women' hospital of Jiangxi, Women and Children's Health Hospital of Qujing, Guiyang Maternal and Child Health Care Hospital, Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region, Chengdu Women's and Children's Central Hospital, People's Hospital of Xinjiang Uygur Autonomous Region, Liuzhou Maternity and Child Healthcare Hospital, Chongqing Medical Center for Women and Children, Hunan children and women' hospital
Conditions	Necrotizing Enterocolitis, Preterm
Enrollment	250 participants
Start Date	2024-09-01
Primary Completion	2029-12-31 (estimated)
Study Completion	2029-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-04-03