Milk Temperature Control and Necrotizing Enterocolitis Risk in Extremely Preterm Infants

NCT06908239 | Active Not Recruiting DMC

• 2 other identifiers: Milk Temperature and NEC2024049
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Necrotizing enterocolitis; preterm

Outcome Measures

Primary Outcomes (1)

• the incidence of necrotizing enterocolitis (NEC)

  Primary outcome was the incidence of necrotizing enterocolitis (NEC), specifically focusing on cases classified as Bell's stage ≥2, according to the modified Bell's staging criteria for NEC

  three months after admission

Secondary Outcomes (6)

• the incidence of bronchopulmonary dysplasia(BPD)

  at 36 weeks' gestational age

• the incidence of late-on sepsis(LOS)

  three months after admission

• the incidence of intraventricular hemorrhage(IVH)

  three months after admission

• the incidence of retinopathy of Prematurity(ROP)

  three months after admission

• the incidence of hematochezia

  three months after admission

Study Arms (2)

thermostatic feeding

EXPERIMENTAL

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: thermostatic feeding

control

ACTIVE COMPARATOR

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.

Other: control

Interventions

thermostatic feeding OTHER

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

thermostatic feeding

control OTHER

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.

control

Eligibility Criteria

• Age: 24 Weeks - 31 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• gestational age at delivery between 24+0 and 31+6 weeks
• initiation of enteral nutrition within 24 hours after birth.

You may not qualify if:

• parental decision to not participate
• presence of major congenital anomalies
• requirement for surgical intervention prior to randomization.
• The subject would be considered censored if the study ended due to one of the following conditions:
• \. Death
• \. Parents' decision to withdraw participation
• \. Discharge based on doctors' recommendations.
• Once enrolled, the neonates received minimal enteral nutrition within the first 24 hours after birth for the initial three days. Following this period, both groups of neonates were fed expressed milk using a pumping system.
• the milk temperature was measured using the following steps:
• \) During the first week after birth, each preterm infant had two identical pumping setups. One pump was used for feeding according to group allocation, while the second, set to zero velocity, was used to measure milk temperature
• \) The temperature from the second pump, taken at the same time milk entered the stomach from the first pump, was recorded as the final milk temperature
• \) After the first week, only one pump was used per infant, and the temperature of the last 1 ml of milk was measured as the final temperature.
• Both groups were supplemented with human milk fortifier (HMF) for preterm infants weighing 1800 g or less. The neonates were fed 50 ml/kg/day of breast milk, following the Chinese Expert Consensus on the Use of Breast Milk Fortifiers in Premature Infants. The milk was sourced from the infant's mother. Initially, infants received half-strength fortified milk for 3-7 days before transitioning to full-strength fortified milk. HMF was discontinued once the infant's body weight reached the 25th-50th percentile for appropriate-for-gestational-age infants or the 10th percentile for small-for-gestational-age infants, depending on sex and gestational age. The choice of formula, HMF, and the decision to add lactase was at the discretion of the attending neonatologist.
• Weaning from thermostatic feeding would occur if any of the following conditions were met:
• \) If no signs of feeding intolerance (FI) appeared after administering pumped milk within 15 minutes for 1-2 days, thermostatic feeding would transition to standard feeding

Sponsors & Collaborators

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: lead
• Children's Hospital of Chongqing Medical University: collaborator
• children and women' hospital of Jiangxi: collaborator
• Women and Children's Health Hospital of Qujing: collaborator
• Guiyang Maternal and Child Health Care Hospital: collaborator
• Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region: collaborator
• Chengdu Women's and Children's Central Hospital: collaborator
• People's Hospital of Xinjiang Uygur Autonomous Region: collaborator
• Liuzhou Maternity and Child Healthcare Hospital: collaborator
• Chongqing Medical Center for Women and Children: collaborator
• Hunan children and women' hospital: collaborator

Study Sites (1)

Chongqing Health Center for Women and Children

Chongqing, Chongqing Municipality, 401147, China

Location

MeSH Terms

Conditions

Enterocolitis, Necrotizing; Premature Birth

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Long Long, MD.,PhD

  Women and Children's Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Model Details: 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

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: April 3, 2025
• Study Start: September 1, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 3, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: patients data after paper published after request for three months
• Access Criteria: Doctor Long Chen. patients' data after request

Locations

CN (1)