Feeding tolerance of a formula for premature infants versus donor breast milk in the first two weeks of life: a randomized not-inferiority trial

Feeding tolerance of a formula for premature infants versus donor breast milk in the first two weeks of life: a randomized not-inferiority trial - Feeding tolerance of a formula for premature infants versus donor breast milk: a randomized control trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013922

Enrollment

Registered

2014-12-31

Start date

2015-01-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatology

Interventions

formula milk for premature infants donor breast milk

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: gestational age less than or equal to 32 weeks own mother's breast milk absent or insufficient in the first 7 days of life to meet the full infant enteral need start of enteral nutrition in the first 7 days of life

Exclusion criteria

Exclusion criteria: congenital surgical disease, major malformation syndromes, abnormal prenatal Doppler velocimetry (AED and ARED), sepsis in the first 72 hours of life.

Design outcomes

Primary

Measure	Time frame
day of life when full enteral feeding of 150 ml / kg is reached	—

Secondary

Measure	Time frame
gastrointestinal hormones at birth, at 8 and 15 days of life; faecal calprotectin at at birth, at 8 and 15 days of life; abdominal Doppler velocimetry at birth, at 8 and 15 days of life;	—

Countries

Europe

Contacts

Public ContactCosta Simonetta

University Hospital "A. Gemelli", Rome, Italy Division of Neonatology

simocosta@yahoo.it+81-0390630154357

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026