Milk Temperature Control and Necrotizing Enterocolitis Risk in Extremely Preterm Infants

NAActive, not recruitingINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

September 1, 2024

Primary Completion Date

December 31, 2029

Study Completion Date

December 31, 2029

Conditions
Necrotizing EnterocolitisPreterm
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.

Trial Locations (1)

401147

Chongqing Health Center for Women and Children, Chongqing

All Listed Sponsors
collaborator

Children's Hospital of Chongqing Medical University

OTHER

collaborator

children and women' hospital of Jiangxi

UNKNOWN

collaborator

Women and Children's Health Hospital of Qujing

OTHER

collaborator

Guiyang Maternal and Child Health Care Hospital

OTHER

collaborator

Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region

OTHER

collaborator

Chengdu Women's and Children's Central Hospital

OTHER

collaborator

People's Hospital of Xinjiang Uygur Autonomous Region

OTHER

collaborator

Liuzhou Maternity and Child Healthcare Hospital

OTHER

collaborator

Chongqing Medical Center for Women and Children

OTHER

collaborator

Hunan children and women' hospital

UNKNOWN

lead

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

OTHER

NCT06908239 - Milk Temperature Control and Necrotizing Enterocolitis Risk in Extremely Preterm Infants | Biotech Hunter | Biotech Hunter