Necrotizing EnterocolitisNECNCT06908239
Milk Temperature Control and Necrotizing Enterocolitis Risk in Extremely Preterm Infants
A study testing thermostatic feeding in people with Necrotizing Enterocolitis and Preterm, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial 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%… Read more about this study
- Who is it for?
- Ages 24 to 31 weeks
- Conditions the study is for
- Necrotizing Enterocolitis, Preterm
- What is being tested?
- thermostatic feeding
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 31 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- gestational age at delivery between 24+0 and 31+6 weeks
- initiation of enteral nutrition within 24 hours after birth.
Who cannot join
- 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:
- 1. Death
- 2. Parents' decision to withdraw participation
Show all 17Show fewer
- 3. 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:
- 1) 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
- 2) 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
- 3) 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:
- 1) 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
- 2) The feeding duration could be gradually reduced in 10-minute increments down to a minimum of 15 minutes. Weaning from standard feeding would occur if no FI was observed after oral feeding within 30 minutes for 1-2 days.
- Due to the lack of existing intervention-based evidence for reference, we based our sample size calculation on an RCT that examined the impact of feeding patterns (human milk-based diet vs. bovine milk-based products). According to the published data, the incidence of NEC was significantly lower in infants receiving an exclusively human-milk-based diet (4.5%) compared to those receiving bovine milk-based products (15.9%; p = 0.04), with approximately 10% in difference of incidence. Using previously published data on NEC prevention, we conducted a power analysis for a superiority clinical trial. To achieve 80% power with a 5% Type I error rate (α = 0.05), we estimated a sample size of 100 participants per group (n₁ = 100, n₂ = 100). Considering a 20% loss to follow-up, we adjusted the sample size to 120 participants per group to ensure adequate power to detect an approximately 10% difference in NEC incidence between the intervention and control groups (R version 4.2.2).
Trial locations and contacts
1 site in 1 country.
China1 site
Chongqing Health Center for Women and Children
Chongqing, Chongqing Municipality, 401147
About this study
Official title: Milk Temperature Control and Necrotizing Enterocolitis Risk in Extremely Preterm Infants: a Randomized Trial
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).
Read the detailed description
Although the pathophysiology of NEC is not fully understood, epidemiological studies strongly suggest a multifactorial cause, involving infection and inflammation, premature birth, hypoxic-ischemia, improper feeding, and cold exposure. As for cold exposure, it encompasses inhaling cold air through the respiratory tract, contact with cold environments through the skin, and consuming cold food through the digestive tract. Such exposure increases the risks of cardiovascular hospitalization, temperature-related mortality, allergic diseases including asthma and atopic dermatitis, and neonatal death. A recent study by Lyu et al. suggested that admission hypothermia is associated with an increased incidence of NEC. However, no research has systematically explored how preventing cold exposure, such as through milk feeding via the digestive tract, could potentially reduce the development of NEC among EPIs/VPIs.
Covariates collected using medical records throughout study conduction included maternal age, neonatal sex, birthweight and gestational age at delivery, and weekly weight until discharged. Gestational diabetes mellitus was diagnosed based on a 2-hour 75g three-time-point oral glucose tolerance test was performed at the clinic according to the International Association of Diabetes and Pregnancy Study (IADPSG) criteria adopted by Chinese Obstetrics and Gynecology guidelines between 24 and 28 weeks of gestation. The investigators collected information on clinical diagnosis of hypertension disorders during pregnancy (HDP) from medical records, which was defined by systolic blood pressure (SBP) ≥140 mm Hg and/or diastolic blood pressure (DBP) ≥ 90 mm Hg, with positive proteinuria, at any timepoints between week 20 and delivery.Other pregnancy outcomes or complications were also retrieved from the medical databased, such as the admission of antenatal corticoids, placenta previa, premature rupture of the membrane, and intrahepatic cholestasis of pregnancy that were diagnosed based on national guidelines. As for infants, neonatal critical case score (NCIS) were assessed within 24 hours of admission and divided into non-critical group (>90), critical group (70-90) and extremely critical group (<70) according to the Chinese Pediatric guidelines. Others neonatal medical conditions during hospitalization were also recorded if diagnosed based on international guidelines, namely small-for-gestational age (SGA), respiratory distress syndrome (RDS) and early onset of sepsis (EOS) within three days after birth. In addition, the days to diagnosis of NEC, length of stay during hospitalization, and cases of surgery among NEC cases were collected from thermostatic feeding and standard feeding groups.
- Conditions
- Necrotizing Enterocolitis, Preterm
- Being tested
- thermostatic feeding, control
- Keywords
- Necrotizing enterocolitis, preterm
- Medical subject headings
- Enterocolitis, Necrotizing, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thermostatic feedingOther
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
controlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: three months after admission
Secondary outcomes (6)
the incidence of bronchopulmonary dysplasia(BPD)
Bronchopulmonary dysplasia (BPD) was diagnosed at a corrected gestational age of 36 weeks, following the NICHD definition established in 2019
Measured: at 36 weeks' gestational age
the incidence of late-on sepsis(LOS)
Late-onset sepsis (LOS) was defined by the expert consensus on the diagnosis and management of neonatal sepsis (version 2019) with onset beyond three days after admission
Measured: three months after admission
the incidence of intraventricular hemorrhage(IVH)
Intraventricular hemorrhage (IVH) was presented with grades 1-4.
Measured: three months after admission
the incidence of retinopathy of Prematurity(ROP)
Retinopathy of prematurity (ROP) was categorized according to the International Classification of Retinopathy of Prematurity, revised in 2005
Measured: three months after admission
the incidence of hematochezia
Hematochezia was presented and diagnosed
Measured: three months after admission
the incidence of extra-uterine growth restriction(EUGR)
Extrauterine growth retardation (EUGR) was identified at a corrected gestational age of 36 weeks, based on the Fenton growth chart for preterm infants
Measured: at 36 weeks' corrected gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start1 Sep 2024
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotizing EnterocolitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Chen Long,MD, Chongqing Medical Center for Women and Children
- Investigators
- Long Long, MD.,PhD, Principal investigator, Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06908239
- Sponsor's protocol ID
- Milk Temperature and NEC
- Other IDs
- 2024049
- Acronym
- NEC
- Status last verified
- Sep 2024
- First submitted
- 20 Mar 2025
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: patients data after paper published after request
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Milk Temperature Control and Necrotizing Enterocolitis Risk in Extremely Preterm Infants: a Randomized Trial
- ClinicalTrials.gov ID
- NCT06908239
- Acronym / sponsor ID
- NEC / Milk Temperature and NEC
- Conditions
- Necrotizing Enterocolitis, Preterm
- Keywords
- Necrotizing enterocolitis, preterm
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- 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
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 3 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Although the pathophysiology of NEC is not fully understood, epidemiological studies strongly suggest a multifactorial cause, involving infection and inflammation, premature birth, hypoxic-ischemia, improper feeding, and cold exposure. As for cold exposure, it encompasses inhaling cold air through the respiratory tract, contact with cold environments through the skin, and consuming cold food through the digestive tract. Such exposure increases the risks of cardiovascular hospitalization, temperature-related mortality, allergic diseases including asthma and atopic dermatitis, and neonatal death. A recent study by Lyu et al. suggested that admission hypothermia is associated with an increased incidence of NEC. However, no research has systematically explored how preventing cold exposure, such as through milk feeding via the digestive tract, could potentially reduce the development of NEC among EPIs/VPIs.
Covariates collected using medical records throughout study conduction included maternal age, neonatal sex, birthweight and gestational age at delivery, and weekly weight until discharged. Gestational diabetes mellitus was diagnosed based on a 2-hour 75g three-time-point oral glucose tolerance test was performed at the clinic according to the International Association of Diabetes and Pregnancy Study (IADPSG) criteria adopted by Chinese Obstetrics and Gynecology guidelines between 24 and 28 weeks of gestation. The investigators collected information on clinical diagnosis of hypertension disorders during pregnancy (HDP) from medical records, which was defined by systolic blood pressure (SBP) ≥140 mm Hg and/or diastolic blood pressure (DBP) ≥ 90 mm Hg, with positive proteinuria, at any timepoints between week 20 and delivery.Other pregnancy outcomes or complications were also retrieved from the medical databased, such as the admission of antenatal corticoids, placenta previa, premature rupture of the membrane, and intrahepatic cholestasis of pregnancy that were diagnosed based on national guidelines. As for infants, neonatal critical case score (NCIS) were assessed within 24 hours of admission and divided into non-critical group (>90), critical group (70-90) and extremely critical group (<70) according to the Chinese Pediatric guidelines. Others neonatal medical conditions during hospitalization were also recorded if diagnosed based on international guidelines, namely small-for-gestational age (SGA), respiratory distress syndrome (RDS) and early onset of sepsis (EOS) within three days after birth. In addition, the days to diagnosis of NEC, length of stay during hospitalization, and cases of surgery among NEC cases were collected from thermostatic feeding and standard feeding groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| thermostatic feeding | Experimental | Other: thermostatic feedingIn 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 |
| control | Active comparator | Other: controlIn 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. |
Who may qualify
- Ages
- 24 to 31 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- gestational age at delivery between 24+0 and 31+6 weeks
- initiation of enteral nutrition within 24 hours after birth.
Key exclusion criteria (17 listed)
- 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:
- 1. Death
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thermostatic feedingIn 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 |
| controlIn 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 |
Primary outcome
the incidence of necrotizing enterocolitis (NEC)
Time frame: three months after admission
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
6 secondary outcomes
the incidence of bronchopulmonary dysplasia(BPD)
Time frame: at 36 weeks' gestational age
the incidence of late-on sepsis(LOS)
Time frame: three months after admission
the incidence of intraventricular hemorrhage(IVH)
Time frame: three months after admission
the incidence of retinopathy of Prematurity(ROP)
Time frame: three months after admission
the incidence of hematochezia
Time frame: three months after admission
the incidence of extra-uterine growth restriction(EUGR)
Time frame: at 36 weeks' corrected gestational age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: Yes. patients data after paper published after request
Related trials for Necrotizing Enterocolitis
Active, not recruitingObservational study
Early Predictors of Necrotizing Enterocolitis in Neonates
Necrotizing Enterocolitis
Recruiting
Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
Very Preterm Infant, Necrotizing Enterocolitis (NEC)
RecruitingObservational study
The Correlation Between Red Cell Transfusion and Complications of Prematurity
Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD)
RecruitingPhase 1
Gut Permeability and Microbiome in Preterm Infants
Prematurity Complications
Recruiting
WithHolding Enteral Feeds Around Blood Transfusion (International)
Necrotizing Enterocolitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Long Long, MD.,PhD principal investigator
Children's Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thermostatic feeding in people with Necrotizing Enterocolitis and Preterm, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of necrotizing enterocolitis (NEC) (time frame: three months after admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.