Post-discharge growth, body composition and neurodevelopment outcome of very preterm infants in relation to two formulas with different composition in terms of energy and protein content

Post-hospital discharge feeding for very preterm infants: effects of standard compared with enriched milk formula on growth, body composition and neurodevelopment outcome - a single centre randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN30189842

Enrollment

184

Registered

2009-09-04

Start date

2009-09-15

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

Pre-term infant post-discharge nutrition and body composition Pregnancy and Childbirth Disorders related to short gestation and low birth weight, not elsewhere classified

Interventions

Infants will be enrolled at term equivalent age and will be prospectively followed-up from term to 12 months of corrected age. At term equivalent age infants will be randomised in four groups: Group

75 kcal/100 ml) Group 2: infants born AGA fed standard formula (1.4 g/100 ml

67 kcal/100 ml) Group 3: infants born small for gestational age (SGA) fed nutrient-enriched post-discharge formula (2.2 g/100 ml

75 kcal/100 ml) Group 4: infants born SGA fed standard formula (1.4 g/100 ml

67 kcal/100 ml) From term up to the six month, infants will be fed a nutrient-enriched post-discharge or standard formula (according to randomisation) on demand and will be given no other foods. Pare

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Birth weight less than 1500 g 2. Gestational age less than 33 weeks 3. Caucasian race, either sex 4. Informed consent signed by infants' parents or legal guardian

Exclusion criteria

Exclusion criteria: 1. Congenital diseases 2. Chromosomal abnormalities 3. Severe gastrointestinal diseases (i.e. necrotising enterocolitis) 3. Metabolic and or endocrine disease 4. Severe brain injury 5. Chronic lung disease

Design outcomes

Primary

Measure	Time frame
1. Body composition (assessed by means of an air plethismography-Pea Pod and the four skinfold thicknesses [triceps, biceps, subscapular and suprailiac] with use of a skinfold calliper), at term corrected age, 15 d, 1, 3, 5, 6 and 12 months of corrected age 2. Growth (weight, length and head circumference assessed at term corrected age, 15 d, 1, 3, 5, 6 and 12 months of corrected age)	—

Secondary

Measure	Time frame
Neurodevelopment outcome (by means of a neurofunctional evaluation at 40 weeks, 3, 6, 12 months' corrected age) and the Griffith Scale (at 12 months of corrected age).	—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 8, 2026