Effect on body and brain development of feeding very premature babies with breast milk containing different supplements

Effect of different composition of human milk and its fortification in body composition and neurodevelopment in a cohort of very preterm infants: a observational cohort study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN27916681

Enrollment

Registered

2015-02-11

Start date

2014-02-01

Completion date

Unknown

Last updated

2018-06-18

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

Conditions

Body composition, BSDI II at 12 and 18 months Nutritional, Metabolic, Endocrine

Interventions

1. Normal variation in human milk composition 2. Blind fortification plus protein supplementation - caregivers and evaluators blind to macronutrient composition.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Preterms with less 34 weeks gestational age

Exclusion criteria

Exclusion criteria: 1. Congenital malformations 2. Formula feeding 3. Inability to achieve full enteral feeding 4. Parents inability to understand informed consent

Design outcomes

Primary

Measure	Time frame
1. Body composition by plethysmography at 40 weeks 2. Bayley Scales of Infant Development II (BSDI II) at 18 months	—

Secondary

Measure	Time frame
Neonatal morbidities	—

Countries

Portugal

Contacts

Public ContactIsrael Macedo

Outcome results

None listed

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