Milk Temperature Control and Necrotizing Enterocolitis Risk in Extremely Preterm Infants

Summary

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).

Conditions

• Necrotizing Enterocolitis
• Preterm

Interventions

OTHER

thermostatic feeding

In the thermostatic feeding group (intervention arm), milk or formula was delivered directly into the stomach via an infusion pump (Model 8713030CN, Shenzhen Shengnuo Medical Equipment Co., Ltd., Shenzhen, Guangdong, China) located within the incubator. The initial temperature of the milk was set at 38°C, and naturally decreased to match that of the incubator, maintaining a stable, thermostatic environment until the completion of feeding, as well as the setting and adjustment of the temperature of incubator according to the Chinese Medical Association guidelines

OTHER

control

In the control arm, standard feeding involved delivering breast milk or formula directly into the stomach using an infusion pump (Model 8713030CN) placed on an infusion stand. The initial temperature of the milk or formula was set at 38°C, and the temperature was allowed to naturally decrease to match the ambient air temperature of the NICU until feeding was completed. For both groups, the feeding volume and speed were managed in accordance with the clinical application guidelines for neonatal nutrition support in China.

Sponsors & Collaborators

• Children's Hospital of Chongqing Medical University

  collaborator OTHER

• children and women' hospital of Jiangxi

  collaborator UNKNOWN

• Women and Children's Health Hospital of Qujing

  collaborator OTHER

• Guiyang Maternal and Child Health Care Hospital

  collaborator OTHER

• Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region

  collaborator OTHER

• Chengdu Women's and Children's Central Hospital

  collaborator OTHER

• People's Hospital of Xinjiang Uygur Autonomous Region

  collaborator OTHER

• Liuzhou Maternity and Child Healthcare Hospital

  collaborator OTHER

• Chongqing Medical Center for Women and Children

  collaborator OTHER

• Hunan children and women' hospital

  collaborator UNKNOWN

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

  lead OTHER

Principal Investigators

• Long Long, MD.,PhD · Women and Children's Hospital of Chongqing Medical University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

24 Weeks

Max Age

31 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-01

Primary Completion

2029-12-31

Completion

2029-12-31

Countries

• China

Study Locations