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
Completed
- Conditions
- Pre-term infant post-discharge nutrition and body compositionPregnancy and ChildbirthDisorders related to short gestation and low birth weight, not elsewhere classified
- Registration Number
- ISRCTN30189842
- Lead Sponsor
- Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli Regina Elena (Italy)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 184
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>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 Outcome Measures
Name Time Method eurodevelopment 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).