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Milk Temperature Control and Necrotizing Enterocolitis Risk in Preterm Neonates: A Randomized Controlled Trial

Study on pumping milk dring neonatal period: a RCT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100044805
Enrollment
Unknown
Registered
2021-03-27
Start date
2021-06-01
Completion date
Unknown
Last updated
2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

necrotizing enterocolitis

Interventions

Experimental group:Thermostatic feeding: First, breast milk or formula was warmed to 38 °C. The warmed milk (38 °C) was then aspirated using a clinically standard syringe and placed on an infusion pum
Shenzhen Sino Medical Equipment Co., Ltd., Shenzhen, Guangdong, China) inside the incubator to initiate feeding. During the infusion, the milk temperature gradually decreased and eventually equilibrat
Control group:Standard feeding:Using the same model of infusion pump and syringe, feeding was performed with the equipment placed on a stand outside the incubator. The initial temperature of the breas

Sponsors

The Children's Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Gestational age less than 32 weeks; 2. Initiation of enteral nutrition within 24 hours after birth.

Exclusion criteria

Exclusion criteria: 1. Parental decision to not participate; 2. Presence of major congenital anomalies; 3. Requirement for surgical intervention prior to randomization.

Design outcomes

Primary

MeasureTime frame
The incidence of necrotizing enterocolitis (NEC);

Secondary

MeasureTime frame
Time to full gastrointestinal nutrition(days);Weekly weight growth(g/d);The incidence of feeding intolerance;The incidence of retinopathy of prematurity;The incidence of intraventricular hemorrhage;The incidence of bronchopulmonary dysplasia;The incidence of extraurine growth restriction;The incidence of late onset sepsis;Number of fasting episodes;Number of milk volume reductions;Duration of hospitalization;

Countries

China

Contacts

Public ContactLiu Xuexiu

The Children's Hospital of Chongqing Medical University

lx198691lx@163.com+86 132 0612 1943

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 13, 2026