An interventional study of Pasteurized Donor Milk for Insufficient Breastfeeding and Preterm Formula for Insufficient Breastfeeding in Very Preterm Infant and Necrotizing Enterocolitis (NEC), sponsored by The Children's Hospital of Zhejiang University School of Medicine. Recruiting at 24 sites in China. Open to participants aged 1 Day to 90 Days. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by The Children's Hospital of Zhejiang University School of Medicine · Not applicable, Interventional, and Prevention
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:
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.
228 studies on the registry are indexed under Enterocolitis, Necrotizing; 44 are open to participants now.
This study's planned enrollment of 2,324 is above the median of 103 across 127 interventional studies indexed under Enterocolitis, Necrotizing.
Browse Enterocolitis, Necrotizing studies →The Children's Hospital of Zhejiang University School of Medicine is the lead sponsor of 69 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive pasteurized donor human milk (pHDM) as supplemental feeding when the clinician determines maternal milk supply is insufficient.
Dietary Supplement: Pasteurized Donor Milk for Insufficient Breastfeeding · Dietary Supplement: Routine fortification · Dietary Supplement: Rescue fortification
Participants receive preterm formula (PTF) as supplemental feeding when the clinician determines maternal milk supply is insufficient.
Dietary Supplement: Preterm Formula for Insufficient Breastfeeding · Dietary Supplement: Routine fortification · Dietary Supplement: Rescue fortification
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.
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.
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
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).
Survival without surgical NEC
Survival to 34 weeks corrected gestational age without surgical necrotizing enterocolitis (NEC)
Time frame: 34 weeks corrected gestational age
NEC requiring surgical intervention
Time frame: 34 weeks gestational age
Survival
Time frame: 28 days after birth
Survival that occurred during hospitalization
Survival: Survival outcome indicators measure the success of enduring life-threatening conditions, eg. survival rate.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From birth until 2 years corrected age.
Body length
Body length: Measurements of the infant's body length at 2 years corrected age.
Time frame: From birth until 2 years corrected age.
Head circumference
Head circumference: Measurements of the infant's head circumference at 2 years corrected age.
Time frame: 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.
Time frame: At 2 years corrected age
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Started Jan 2026 (actual). Primary completion is estimated for Jul 2028, 30 months after the start.
Of 33 interventional studies with no phase under Enterocolitis, Necrotizing, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 59. This study's planned 30 months is below that.
Start moved once since we started tracking on Sep 25, 2026: Mar 2026 → Jan 2026, on Oct 26, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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The Children's Hospital of Zhejiang University School of Medicine