Exploratory randomised double-blind controlled trial of breast milk fortifier with and without long chain polyunsaturated fatty acid (LCPUFA) supplementation on body composition in preterm infants

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN59878178

Enrollment

Registered

2005-09-13

Start date

2005-08-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Preterm infants Neonatal Diseases

Interventions

Infants will receive maternal +/- donor breast milk

should breast milk fortifier be indicated in accordance with normal clinical practice, infants will be randomised to receive standard fortifier or LCPUFA supplemented fortifier.

Eligibility

Inclusion criteria

Inclusion criteria: Infants born at or below 32 weeks gestational age

Exclusion criteria

Exclusion criteria: 1. Major congenital abnormality 2. Mother does not wish to provide breast milk or to use donor milk 3. Baby requires gastrointestinal surgery

Design outcomes

Primary

Measure	Time frame
Body composition at age term-equivalent	—

Secondary

Measure	Time frame
Growth, metabolic profile, intrahepatocellular lipid content, brain growth and development, neurological examination	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026