The Preterm Prebiotic Study
Completed
- Conditions
- Neonatal Diseaseseonatal nutritional supplementation
- Registration Number
- ISRCTN77444690
- Lead Sponsor
- Milupa GmbH, Numico Research (Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 160
Inclusion Criteria
Preterm infants, appropriately grown for gestational age, with a gestational age =32 + 6 weeks (days), whose mothers agree to the use of formula if they are unable to or do not wish to breast feed or are not able to provide sufficient breast milk
Exclusion Criteria
1. More than 72 hours exclusive parenteral nutrition
2. Immediately life-threatening congenital abnormality
3. Any condition requiring major surgery
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Number of days from birth to reach a total (sole formula or formula with breast milk) daily enteral intake of 150 ml/kg<br>2. Number of days between birth and 28 days that a total (sole formula or formula with breast milk) daily enteral intake of at least 150 ml/kg is tolerated
- Secondary Outcome Measures
Name Time Method 1. Gain in weight, length and head circumference<br>2. Faecal flora<br>3. Faecal calprotectin<br>4. Faecal characteristics<br>5. Gastrointestinal tolerance<br>6. Fluid balance<br>7. Necrotising enterocolitis<br>8. Bloodstream infection