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A Randomized Controlled Trial of Donor Human Milk Administration for the Prevention of Allergic Diseases and Prematurity-Related Complications in Preterm and Low Birth Weight Infants

A Study to Determine Whether Donor Human Milk Can Prevent Allergic Diseases and Complications Related to Prematurity in Preterm and Low Birth Weight Infants

Yamashita Kosei

Department of Pediatrics, Showa Medical University School of Medicine.

1-5-8, Hatanodai, Shinagawa-Ku, Tokyo

meko11115@med.showa-u.ac.jp

Yamashita Kosei

Department of Pediatrics, Showa Medical University School of Medicine.

1-5-8, Hatanodai, Shinagawa-Ku, Tokyo

+81-3-3784-8565

meko11115@med.showa-u.ac.jp

Recruiting

May. 20, 2026

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

prevention purpose

This study targets infants born before 37 weeks of gestation, weighing between 1,500g and 2,000g, and admitted to the NICU.

1) Patients admitted to the NICU after day 2 of age, 2) Patients with severe liver or kidney impairment, 3) Patients suffering from heart disease or other conditions, and 4) Patients deemed ineligible by the research physician.

Both

Premature birth and low birth weight babies

Participants will be randomly divided into two groups: a donor milk group (provided by the Japan Breast Milk Bank Foundation) and a formula milk group.

Each participant will use either donor milk or formula milk, with at least 10 mL/day of either. The intervention period will be two weeks. After the intervention period, breast milk will be used, supplemented by formula milk if breast milk is insufficient. Similar management will be continued after discharge from the NICU, and intake will be monitored until 6 months of age. There will be no restrictions on the timing of introducing complementary foods.

Premature birth and low birth weight babies, food allergy, asthma, atopic dermatitis, human donor milk

D047928, D007230

Prevalence of Egg Food Allergy at 12 Months of Age
Food allergy is diagnosed by performing a skin prick test on foods that have not reached the daily intake level (1600 mg of egg protein, approximately half an egg) at 12 months of age. If the test is positive, an oral food challenge test is performed using the daily intake level. If the skin prick test is negative, or if the daily intake level is reached, the child is diagnosed as not having a food allergy. If the child has a history of allergic symptoms after consuming eggs, milk, or wheat, and an allergist has diagnosed a food allergy at 1 year of age, an oral food challenge test is not performed.
Infants with a negative SPT result or those who have already reached the predefined daily intake (1600 mg of hen's egg protein) without symptoms will be diagnosed as not having food allergy.

1. Prevalence of milk and wheat food allergies at 12 months of age:
Skin prick tests were performed for foods not reaching the daily intake level (3300 mg of milk protein, approximately 100 mL of milk; 1325 mg of wheat protein, approximately 50 g of udon noodles) at 12 months of age. If positive, an oral food challenge test was performed using the daily intake level. If the skin prick test was negative, or if the daily intake level was reached, the child was diagnosed as not having a food allergy.
2. Primary endpoints were analyzed stratified by milk intake in both groups.
3. Prevalence of bronchial asthma and atopic dermatitis at 3, 6, and 12 months of age.
4. Allergen sensitization rates (eggs, milk, wheat) at 12 months of age were confirmed using skin prick tests and blood tests.
5. Complications in premature infants during NICU admission (respiratory distress, infections, gastrointestinal diseases such as necrotizing enterocolitis, retinopathy of prematurity, intraventricular hemorrhage)
6. Evaluate family allergy history and birth information (Apgar score, mode of delivery, timing of delivery, maternal complications, use of antibiotics during pregnancy, etc.).

+81-3-3784-8129

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