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| Name | Class |
|---|---|
| Imperial College London | OTHER |
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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:
COLLABORATE-China is being run in partnership with the UK-wide COLLABORATE trial sponsored by Imperial College London.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Preterm formula for Insufficient Breastfeeding | Experimental | Participants receive preterm formula (PTF) as supplemental feeding when the clinician determines maternal milk supply is insufficient. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pasteurized Donor Milk for Insufficient Breastfeeding | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Survival without surgical NEC | Survival to 34 weeks corrected gestational age without surgical necrotizing enterocolitis (NEC) | 34 weeks corrected gestational age |
| Measure | Description | Time Frame |
|---|---|---|
| NEC requiring surgical intervention | 34 weeks gestational age | |
| Survival | 28 days after birth | |
| Survival that occurred during hospitalization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanping Xu | Contact | 8613685757726 | xuyanping726@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Guilin Medical University | Guilin | Guangxi | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Nov 26, 2025 |
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| Preterm Formula for Insufficient Breastfeeding | Dietary 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. |
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| Routine fortification | Dietary 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 |
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| Rescue fortification | Dietary 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). |
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Survival: Survival outcome indicators measure the success of enduring life-threatening conditions, eg. survival rate. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | From birth until 2 years corrected age. |
| Body length | Body length: Measurements of the infant's body length at 2 years corrected age. | From birth until 2 years corrected age. |
| Head circumference | Head circumference: Measurements of the infant's head circumference at 2 years corrected age. | From birth until 2 years corrected age. |
| Parent Report of Children's Abilities-Revised (PARCA-R) assessment | Survival without moderate to severe cognitive or language impairment. PARCA-R stands for Parent Report of Children's Abilities-Revised. It is a parent completed questionnaire that can be used to assess children's cognitive and language development at 24 months of age. | At 2 years corrected age |
| The Second Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi | 530007 | China |
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| Yulin Maternity and Child Health Care Hospital, Guangxi | Yulin | Guangxi | 537000 | China |
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| The Affiliated Hospital of Guizhou Medical University | Guizhou | Guiyang | 550001 | China |
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| Nanyang Central Hospital | Nanyang | Henan | 473000 | China |
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| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | China |
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| Yiyang Central Hospital | Yiyang | Hunan | China |
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| Ganzhou Maternal and Child Health Hospital | Ganzhou | Jiangxi | China |
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| Peking University First Hospital Ningxia Women and Children's Hospital (Ningxia Hui Autonomous Region Maternal and Child Health Hospital) | Yinchuan | Ningxia | China |
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| Shandong Provincial Maternal and Child Health Care Hospital | Jinan | Shandong | China |
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| Sichuan Provincial Maternal and Child Health Hospital | Chengdu | Sichuan | 610045 | China |
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| The Affiliated Hospital of Southwest Medical University | Luzhou | Sichuan | China |
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| People's Hospital of Xinjiang Uygur Autonomous Region | Ürümqi | Xinjiang Uygur Autonomous Region | China |
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| Yongkang Maternity and Child Health Care Hospital | Guli | Zhejiang | 321300 | China |
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| Children's Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 0571 | China |
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| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310003 | China |
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| Women's Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310006 | China |
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| Hangzhou Women's Hospital | Hangzhou | Zhejiang | 310008 | China |
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| Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310016 | China |
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| Jiaxing Maternity and Child Health Care Hospital | Jiaxing | Zhejiang | 314000 | China |
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| Ningbo Women and Children's Hospital (The Affiliated Women and Children's Hospital of Ningbo University) | Ningbo | Zhejiang | 315012 | China |
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| Yiwu Maternity and Child Health Care Hospital (Yiwu Branch of The Children's Hospital, Zhejiang University School of Medicine) | Yiwu | Zhejiang | 322000 | China |
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| Nov 26, 2025 |
| Prot_SAP_ICF_001.pdf |
| ID | Term |
|---|---|
| D020345 | Enterocolitis, Necrotizing |
| ID | Term |
|---|---|
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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