Very Preterm InfantNCT07045844
Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
A study testing Pasteurized Donor Milk for Insufficient Breastfeeding, Preterm Formula for Insufficient Breastfeeding and Routine fortification in people with Very Preterm Infant and Necrotizing Enterocolitis (NEC), run by The Children's Hospital of Zhejiang University School of Medicine at 24 sites in China.
Trial summary
The goal of this clinical trial is to evaluate whether supplementing with pasteurized donor human milk (pHDM) or preterm formula (PTF) when own mother's milk (OMM) is insufficient can improve outcomes in very preterm infants born before 29 weeks of gestation. Read more about this study
- Who is it for?
- Ages 1 day to 90 days
- Conditions the study is for
- Very Preterm Infant, Necrotizing Enterocolitis (NEC)
- What is being tested?
- Pasteurized Donor Milk for Insufficient Breastfeeding, Preterm Formula for Insufficient Breastfeeding and Routine fortification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,324 participants
- Where
- 24 sitesChina
- Study dates
- 23 Jan 2026to 31 Jul 2030
- 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 1 day to 90 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age at birth less than 29 weeks;
- No contraindications to enteral feeding;
- Mother is willing to breastfeed.
Who cannot join
- For Randomization Group 1: If the infant has already received pasteurized human donor milk (pHDM), preterm formula (PTF), or nutritional fortifiers;
- For Randomization Group 2: If the infant is exclusively fed with preterm formula and the mother has no intention to express breast milk;
Trial locations and contacts
24 sites in 1 country. Contact the study team or a site near you to ask about taking part.
24 sites in 1 country
China24 sites, 24 recruiting
- Recruiting
Sichuan Provincial Maternal and Child Health Hospital
Chengdu, Sichuan, 610045
Jingmei Hao, 18280350267
Jingmei Hao
- Recruiting
Ganzhou Maternal and Child Health Hospital
Ganzhou, Jiangxi
Xiaohua Luo, 18079708860
Xiaohua Luo
- Recruiting
The First Affiliated Hospital of Guilin Medical University
Guilin, Guangxi
Yuan Tan, 13707837294
Yuan Tan
- Recruiting
Yongkang Maternity and Child Health Care Hospital
Guli, Zhejiang, 321300
Aijuan Yang, 8613506790182, 55724110@qq.com
Aijuan Yang
- Recruiting
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 0571
Zheng Chen, 0571-13857151000, chenz@zju.edu.cn
Yanping Xu
- Recruiting
Women's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310006
Jiajun Zhu, 8613858089111, jiajunzhu@zju.edu.cn
Jiajun Zhu
- Recruiting
Hangzhou Women's Hospital
Hangzhou, Zhejiang, 310008
Weinong Mo, 8613606719109, hzxsmwn@126.com
Weinong Mo
- Recruiting
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016
Zhou Jiang, 8613588878072, 5200013@zju.edu.cn
Zhou Jiang
- Not yet recruiting
Inner Mongolia Autonomous Region Maternity and Child Health Care Hospital
Hohhot, Inner Mongolia, 010020
Arigong Gaowa, 18604710867, 15389716630@163.com
Arigong Gaowa
- Recruiting
Huzhou Maternity and Child Health Care Hospital
Huzhou, Zhejiang, 313000
Qinqin Fu, 13967250510, 778748271@qq.com
Qinqin Fu
- Recruiting
Jiaxing Maternity and Child Health Care Hospital
Jiaxing, Zhejiang, 314000
Huafei Huang, 8613867344127, 39362000@qq.com
Huafei Huang
- Recruiting
Jinhua Maternity and Child Health Care Hospital
Jinhua, Zhejiang, 321000
Yuan Gao, 13605728733, gyuanjh@foxmail.com
Yuan Gao
- Recruiting
Taizhou Hospital of Zhejiang Province
Linhai, Zhejiang, 317000
Hongping Lu, 13958559180, luhp@enzemed.com
Hongping Lu
- Not yet recruiting
Linyi People's Hospital
Linyi, Shandong, 276003
Fen Cheng, 18253959131
Fen Cheng
- Recruiting
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan
Lan Kang, 13982762269
Lan Kang
- Recruiting
Ningbo Women and Children's Hospital (The Affiliated Women and Children's Hospital of Ningbo University)
Ningbo, Zhejiang, 315012
Qin Lv, 8613738822179, artose@sina.com
Yanhong Li
- Not yet recruiting
Keqiao District Maternity and Child Health Care Hospital
Shaoxing, Zhejiang, 312030
Hongwei Wang, 15988211719, whw918@126.com
Hongwei Wang
- Not yet recruiting
Enze Hospital, Taizhou Enze Medical Center (Group)
Taizhou, Zhejiang, 318053
Linghua Wang, 13957652116, wanglh6019@enzemed.com
Linhua Wang
- Recruiting
Hubei Maternity and Child Health Care Hospital
Wuhan, Hubei, 430070
Yi Zhang, 13871586428, 491768583@qq.com
Yi Zhang
- Recruiting
Peking University First Hospital Ningxia Women and Children's Hospital (Ningxia Hui Autonomous Region Maternal and Child Health Hospital)
Yinchuan, Ningxia
Yuhua Wu, 17709589568
Yuhua Wu
- Recruiting
Yiwu Maternity and Child Health Care Hospital (Yiwu Branch of The Children's Hospital, Zhejiang University School of Medicine)
Yiwu, Zhejiang, 322000
Shujun Chen, 8618314930492, 12444229204@qq.com
Shujun Chen
- Recruiting
Yiyang Central Hospital
Yiyang, Hunan
Xianglian Liu, 15898439990
Xianglian Liu
- Recruiting
Yulin Maternity and Child Health Care Hospital, Guangxi
Yulin, Guangxi, 537000
Yaoxun Wu, 13768963338, 17825765@qq.com
Yaoxun Wu
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Qianya Xu, 13203805371
Qianya Xu
About this study
Official title: The Effects of Different Enteral Feeding Regimens on Necrotizing Enterocolitis, Mortality, and Neurodevelopment in Very Preterm Infants: A Multicenter Double-Randomized Trial
The goal of this clinical trial is to evaluate whether supplementing with pasteurized donor human milk (pHDM) or preterm formula (PTF) when own mother's milk (OMM) is insufficient can improve outcomes in very preterm infants born before 29 weeks of gestation. It also aims to assess whether routine use of human milk fortifiers benefits this population. The main questions it aims to answer are:
Does supplementing OMM with pHDM or PTF improve survival without surgery-requiring necrotizing enterocolitis (NEC) by 34 weeks corrected gestational age? Is routine fortification of human milk better than selective fortification based on growth faltering?
Read more
Researchers will compare:
pHDM vs. PTF to see which better supports survival without severe NEC. Routine fortification vs. selective fortification to assess the impact on growth and long-term neurodevelopment.
Participants will:
Be randomized twice:
- First, within the first week of life to receive either pHDM or PTF when OMM is insufficient
- Second, in the second week of life to receive either routine fortification or selective fortification only if growth faltering occurs Receive feeding and care as per standard clinical practice Complete neurodevelopmental assessment at 2 years corrected age using the Griffiths Mental Development Scales.
This multicenter, double-randomized, open-label randomized controlled trial is embedded in routine neonatal care and uses real-world data to assess both short- and long-term outcomes.
COLLABORATE-China is being run in partnership with the UK-wide COLLABORATE trial sponsored by Imperial College London.
- Being tested
- Pasteurized Donor Milk for Insufficient Breastfeeding, Preterm Formula for Insufficient Breastfeeding, Routine fortification, Rescue fortification
- Medical subject headings
- Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pasteurized Donor Milk for Insufficient BreastfeedingDietary supplement
Participants receive pasteurized donor human milk (pHDM) as supplemental feeding when the clinician determines maternal milk supply is insufficient.
Randomization 1 will occur when the clinician determines that supplemental feeding is required due to insufficient breast milk supply.
Preterm Formula for Insufficient BreastfeedingDietary supplement
Participants receive preterm formula (PTF) as supplemental feeding when the clinician determines maternal milk supply is insufficient.
Randomization 1 will occur when the clinician determines that supplemental feeding is required due to insufficient breast milk supply.
Routine fortificationDietary supplement
Randomization 2 will be conducted when the total daily intake of human milk (including own mother's milk [OMM] and/or donor pasteurized human milk [pHDM] ) reaches between 60-120 mL/kg
Rescue fortificationDietary supplement
Randomization 2 will be conducted: Add fortifiers when the infant meets predefined criteria for growth faltering (Preterm infants exhibit a sustained decline in growth velocity for weight, length, or head circumference, demonstrated by a downward crossing of centiles on growth curves, despite tolerating and consuming at least 180 mL/kg/day of breast milk or formula. Blood urea levels in these infants remain consistently below 1.5 mmol/L, and there are no severe complications such as active sepsis or the need for vasoactive medications to maintain circulatory stability. Chronic sodium depletion has also been ruled out, as this condition alone can lead to growth failure. Additionally, preterm infants are unable to tolerate high-volume feeding of 180 mL/kg/day due to specific reasons, such as severe gastroesophageal reflux or the presence of a high-output stoma following surgical procedures).
| Study group | Role | What they receive |
|---|---|---|
| Pasteurized Donor Milk for Insufficient Breastfeeding | Experimental | Participants receive pasteurized donor human milk (pHDM) as supplemental feeding when the clinician determines maternal milk supply is insufficient. Receives: Dietary Supplement: Pasteurized Donor Milk for Insufficient Breastfeeding; Dietary Supplement: Routine fortification; Dietary Supplement: Rescue fortification |
| Preterm formula for Insufficient Breastfeeding | Experimental | Participants receive preterm formula (PTF) as supplemental feeding when the clinician determines maternal milk supply is insufficient. Receives: Dietary Supplement: Preterm Formula for Insufficient Breastfeeding; Dietary Supplement: Routine fortification; Dietary Supplement: Rescue fortification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival without surgical NEC
Survival to 34 weeks corrected gestational age without surgical necrotizing enterocolitis (NEC)
Measured: 34 weeks corrected gestational age
Secondary outcomes (16)
NEC requiring surgical intervention
Measured: 34 weeks gestational age
Survival
Measured: 28 days after birth
Survival that occurred during hospitalization
Survival: Survival outcome indicators measure the success of enduring life-threatening conditions, eg. survival rate.
Measured: From birth until hospital discharge (up to approximately 44 weeks postmenstrual age)
Medically treated NEC that occurred during hospitalization
Medically treated NEC: Diagnosis of necrotizing enterocolitis that required medical (non-surgical) treatment, such as bowel rest and antibiotic therapy.
Measured: From birth until hospital discharge (up to approximately 44 weeks postmenstrual age)
Treated retinopathy of prematurity (ROP) that occurred during hospitalization
Treated retinopathy of prematurity (ROP): ROP that progressed to a stage requiring medical or surgical intervention, including laser therapy or intravitreal injections.
Measured: From birth until hospital discharge (up to approximately 44 weeks postmenstrual age)
Hearing impairment that occurred during hospitalization
Hearing impairment: Documented hearing loss identified through newborn hearing screening or diagnostic audiology tests, potentially requiring follow-up or intervention.
Measured: From birth until hospital discharge (up to approximately 44 weeks postmenstrual age)
Severe brain injury that occurred during hospitalization
Severe brain injury: Presence of significant brain injury such as Grade III or IV intraventricular hemorrhage (IVH) or periventricular leukomalacia (PVL) as diagnosed by cranial imaging.
Measured: From birth until hospital discharge (up to approximately 44 weeks postmenstrual age)
Length of hospital stay
Length of hospital stay: Total number of days from birth until discharge from the hospital.
Measured: From birth until hospital discharge (up to approximately 44 weeks postmenstrual age)
Number of episodes of bloodstream infection that occurred during hospitalization
Number of episodes of bloodstream infection: Total number of confirmed bloodstream infections (positive blood cultures) during the hospital stay.
Measured: From birth until hospital discharge (up to approximately 44 weeks postmenstrual age)
Events that occurred during hospitalization
Number of days of antibiotic treatment: Cumulative number of days the infant received systemic antibiotic therapy during hospitalization.
Measured: From birth until hospital discharge (up to approximately 44 weeks postmenstrual age)
Number of days on parenteral nutrition that occurred during hospitalization
Number of days on parenteral nutrition: Total number of days the infant received intravenous nutritional support due to inability to tolerate full enteral feeds.
Measured: From birth until hospital discharge (up to approximately 44 weeks postmenstrual age)
Number of days of NPO that occurred during hospitalization
Number of days of NPO: Total number of days the infant was designated "nil per os" (NPO), meaning no enteral feeding was given.
Measured: From birth until hospital discharge (up to approximately 44 weeks postmenstrual age)
Body weight
Growth parameters (weight): Measurements of the infant's body weight at 2 years corrected age.
Measured: From birth until 2 years corrected age.
Body length
Body length: Measurements of the infant's body length at 2 years corrected age.
Measured: From birth until 2 years corrected age.
Head circumference
Head circumference: Measurements of the infant's head circumference at 2 years corrected age.
Measured: From birth until 2 years corrected age.
Griffiths Mental Development Scales
Survival without moderate to severe cognitive or language impairment. Assessment using the Griffiths Mental Development Scales at a corrected age of 2 years.
Measured: At 2 years corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start23 Jan 2026
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Very Preterm InfantStudies of the same condition, open and under way.
- More trials run by The Children's Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 2,324 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London
- Responsible party
- Principal investigator, Yanping Xu, The Children's Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045844
- Sponsor's protocol ID
- 2025-IRB-0232-P-04
- Status last verified
- Oct 2026
- First submitted
- 17 Jun 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Different Enteral Feeding Regimens on Necrotizing Enterocolitis, Mortality, and Neurodevelopment in Very Preterm Infants: A Multicenter Double-Randomized Trial
- ClinicalTrials.gov ID
- NCT07045844
- Acronym / sponsor ID
- 2025-IRB-0232-P-04
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,324 participants (estimated)
- Lead sponsor
- The Children's Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Collaborators
- Imperial College London
- Study start
- 23 Jan 2026 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 1 Jul 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.
The goal of this clinical trial is to evaluate whether supplementing with pasteurized donor human milk (pHDM) or preterm formula (PTF) when own mother's milk (OMM) is insufficient can improve outcomes in very preterm infants born before 29 weeks of gestation. It also aims to assess whether routine use of human milk fortifiers benefits this population. The main questions it aims to answer are:
Does supplementing OMM with pHDM or PTF improve survival without surgery-requiring necrotizing enterocolitis (NEC) by 34 weeks corrected gestational age? Is routine fortification of human milk better than selective fortification based on growth faltering?
Researchers will compare:
pHDM vs. PTF to see which better supports survival without severe NEC. Routine fortification vs. selective fortification to assess the impact on growth and long-term neurodevelopment.
Participants will:
Be randomized twice:
- First, within the first week of life to receive either pHDM or PTF when OMM is insufficient
- Second, in the second week of life to receive either routine fortification or selective fortification only if growth faltering occurs Receive feeding and care as per standard clinical practice Complete neurodevelopmental assessment at 2 years corrected age using the Griffiths Mental Development Scales.
This multicenter, double-randomized, open-label randomized controlled trial is embedded in routine neonatal care and uses real-world data to assess both short- and long-term outcomes.
COLLABORATE-China is being run in partnership with the UK-wide COLLABORATE trial sponsored by Imperial College London.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pasteurized Donor Milk for Insufficient Breastfeeding | Experimental | Dietary Supplement: Pasteurized Donor Milk for Insufficient Breastfeeding, Dietary Supplement: Routine fortification, Dietary Supplement: Rescue fortificationParticipants receive pasteurized donor human milk (pHDM) as supplemental feeding when the clinician determines maternal milk supply is insufficient. |
| Preterm formula for Insufficient Breastfeeding | Experimental | Dietary Supplement: Preterm Formula for Insufficient Breastfeeding, Dietary Supplement: Routine fortification, Dietary Supplement: Rescue fortificationParticipants receive preterm formula (PTF) as supplemental feeding when the clinician determines maternal milk supply is insufficient. |
Who may qualify
- Ages
- 1 day to 90 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Gestational age at birth less than 29 weeks;
- No contraindications to enteral feeding;
- Mother is willing to breastfeed.
Key exclusion criteria (2 listed)
- For Randomization Group 1: If the infant has already received pasteurized human donor milk (pHDM), preterm formula (PTF), or nutritional fortifiers;
- For Randomization Group 2: If the infant is exclusively fed with preterm formula and the mother has no intention to express breast milk;
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 |
|---|---|---|
| Pasteurized Donor Milk for Insufficient BreastfeedingParticipants receive pasteurized donor human milk (pHDM) as supplemental feeding when the clinician determines maternal milk supply is insufficient. Randomization 1 will occur when the clinician determines that supplemental feeding is required due to insufficient breast milk supply. | Dietary supplement | Pasteurized Donor Milk for Insufficient Breastfeeding |
| Preterm Formula for Insufficient BreastfeedingParticipants receive preterm formula (PTF) as supplemental feeding when the clinician determines maternal milk supply is insufficient. Randomization 1 will occur when the clinician determines that supplemental feeding is required due to insufficient breast milk supply. | Dietary supplement | Preterm formula for Insufficient Breastfeeding |
| Routine fortificationRandomization 2 will be conducted when the total daily intake of human milk (including own mother's milk [OMM] and/or donor pasteurized human milk [pHDM] ) reaches between 60-120 mL/kg | Dietary supplement | Pasteurized Donor Milk for Insufficient Breastfeeding, Preterm formula for Insufficient Breastfeeding |
| Rescue fortificationRandomization 2 will be conducted: Add fortifiers when the infant meets predefined criteria for growth faltering (Preterm infants exhibit a sustained decline in growth velocity for weight, length, or head circumference, demonstrated by a downward crossing of centiles on growth curves, despite tolerating and consuming at least 180 mL/kg/day of breast milk or formula. Blood urea levels in these infants remain consistently below 1.5 mmol/L, and there are no severe complications such as active sepsis or the need for vasoactive medications to maintain circulatory stability. Chronic sodium depletion has also been ruled out, as this condition alone can lead to growth failure. Additionally, preterm infants are unable to tolerate high-volume feeding of 180 mL/kg/day due to specific reasons, such as severe gastroesophageal reflux or the presence of a high-output stoma following surgical procedures). | Dietary supplement | Pasteurized Donor Milk for Insufficient Breastfeeding, Preterm formula for Insufficient Breastfeeding |
Primary outcome
Survival without surgical NEC
Time frame: 34 weeks corrected gestational age
Survival to 34 weeks corrected gestational age without surgical necrotizing enterocolitis (NEC)
16 secondary outcomes
NEC requiring surgical intervention
Time frame: 34 weeks gestational age
Survival
Time frame: 28 days after birth
Survival that occurred during hospitalization
Time frame: From birth until hospital discharge (up to approximately 44 weeks postmenstrual age)
Medically treated NEC that occurred during hospitalization
Time frame: From birth until hospital discharge (up to approximately 44 weeks postmenstrual age)
Treated retinopathy of prematurity (ROP) that occurred during hospitalization
Time frame: From birth until hospital discharge (up to approximately 44 weeks postmenstrual age)
Hearing impairment that occurred during hospitalization
Time frame: From birth until hospital discharge (up to approximately 44 weeks postmenstrual age)
Severe brain injury that occurred during hospitalization
Time frame: From birth until hospital discharge (up to approximately 44 weeks postmenstrual age)
Length of hospital stay
Time frame: From birth until hospital discharge (up to approximately 44 weeks postmenstrual age)
Number of episodes of bloodstream infection that occurred during hospitalization
Time frame: From birth until hospital discharge (up to approximately 44 weeks postmenstrual age)
Events that occurred during hospitalization
Time frame: From birth until hospital discharge (up to approximately 44 weeks postmenstrual age)
Number of days on parenteral nutrition that occurred during hospitalization
Time frame: From birth until hospital discharge (up to approximately 44 weeks postmenstrual age)
Number of days of NPO that occurred during hospitalization
Time frame: From birth until hospital discharge (up to approximately 44 weeks postmenstrual age)
Body weight
Time frame: From birth until 2 years corrected age.
Body length
Time frame: From birth until 2 years corrected age.
Head circumference
Time frame: From birth until 2 years corrected age.
Griffiths Mental Development Scales
Time frame: At 2 years corrected 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 26 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Very Preterm Infant
Not yet recruiting
Effects of a Multisensory Intervention Program on the Term Behavior of the Very Premature Baby
Very Premature Baby
Recruiting
Milk And Growth In Children (MAGIC) Born Very Preterm: A Randomized Trial
Prematurity
Active, not recruiting
Serial Brain MRI in Hospitalized Preterm Infants
Preterm Birth Complication
Not yet recruiting
Parent-Facilitated Early Oral-Sensory Experience in the NICU for Feeding Outcomes
Premature Birth, Infant, Premature
Active, not recruiting
Early DHA/ARA Supplementation in Growth-restricted Very Preterm Infants: A Randomized Clinical Trial
Infant Malnutrition, Light-For-Dates With Signs of Fetal Malnutrition
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.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pasteurized Donor Milk for Insufficient Breastfeeding, Preterm Formula for Insufficient Breastfeeding and Routine fortification in people with Very Preterm Infant and Necrotizing Enterocolitis (NEC), run by The Children's Hospital of Zhejiang University School of Medicine at 24 sites 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites 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?
Contact Yanping Xu (8613685757726, xuyanping726@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival without surgical NEC (time frame: 34 weeks corrected gestational age). 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 26 Oct 2026.