Study Towards the Effects of Post-discharge nutrition on growth and body composition of infants born less than or equal to 32 weeks gestation and/or less than or equal to 1500 g birth weight
Completed
- Conditions
- Prematurity, growth retardation (intrauterine and/or postnatal)Neonatal DiseasesNutrition
- Registration Number
- ISRCTN53695702
- Lead Sponsor
- Vrije University Medical Centre (VUMC) (The Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
1. Gestational age less than or equal to 32 weeks with a birth weight less than or equal to 2000 g or a birth weight less than or equal to 1500 g and a gestational age less than or equal to 34 weeks
2. At least one parent or caretaker who speaks Dutch or English
Exclusion Criteria
Conditions that influence the growth like:
1. Severe congenital anomalies
2. Bronchopulmonary dysplasia defined as an O2 requirement above 25% at 36 weeks gestation, any O2 requirement at 38 weeks gestation or any respiratory support at 40 weeks gestation
3. Severe intracerebral haemorrhage or ischaemia diagnosed before inclusion
4. Gastrointestinal surgery and gastrointestinal diseases known to influence growth
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Growth and body composition (bone density, fat percentage).
- Secondary Outcome Measures
Name Time Method 1. Anaemia<br>2. Bone markers<br>3. Protein status<br>4. Metabolism (oleic acid [OA] glucose, cholesterol, insulin-like growth factor-I [IGF-I])<br>5. Free fatty acids in red blood cells<br>6. Neurodevelopment