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Donor Milk
Donor milk provides maternal antibodies, nutrients, and bioactive compounds that support immune development and gastrointestinal health in neonates.
Donor milk provides maternal antibodies, nutrients, and bioactive compounds that support immune development and gastrointestinal health in neonates. Used for Feeding of premature and low-birth-weight infants, Prevention of necrotizing enterocolitis (NEC) in neonates.
At a glance
| Generic name | Donor Milk |
|---|---|
| Sponsor | NICHD Neonatal Research Network |
| Drug class | Nutritional/Immunological supplement |
| Modality | Biologic |
| Therapeutic area | Neonatology |
| Phase | Phase 3 |
Mechanism of action
Donor milk (human breast milk from screened donors) delivers immunoglobulins (particularly IgA), lactoferrin, oligosaccharides, and other antimicrobial and anti-inflammatory factors that enhance mucosal immunity and reduce pathogenic colonization in premature infants. These components promote beneficial microbiota establishment and reduce the risk of necrotizing enterocolitis (NEC) and other infections in vulnerable neonatal populations.
Approved indications
- Feeding of premature and low-birth-weight infants
- Prevention of necrotizing enterocolitis (NEC) in neonates
Common side effects
- Minimal adverse events reported; generally well-tolerated
Key clinical trials
- Promotion of Breast Milk Donation in Breastfeeding Mothers Through a Mobile Health Intervention Using Amamantapp (NA)
- Single-center Evaluation of Human Milk Quantity and Quality Over Five Years
- Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants (NA)
- Comparing Impacts of Donor Human Milk to Formula Supplementation on the Gut Microbiome of Full-term Infants (NA)
- DOnor Milk to REpair the Full-term Infant MIcrobiome in Infants Born Via Cesarean Section. (NA)
- Administration of Extracellular Vesicles From Donor Human Milk in Preterm Infants
- Pasteurised Donor Human Milk Supplementation for Term Babies (PHASE4)
- Post-Discharge Growth of Infants Who Received Donor Human Milk Products in the Neonatal Intensive Care Unit (NICU)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Donor Milk CI brief — competitive landscape report
- Donor Milk updates RSS · CI watch RSS
- NICHD Neonatal Research Network portfolio CI