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The Preterm Prebiotic Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN77444690
Enrollment
160
Registered
2005-09-12
Start date
2005-10-01
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

Neonatal nutritional supplementation Neonatal Diseases

Interventions

Infants randomised to one of two groups receiving either Nutriprem A or B, one without and one with 0.8 g GOS/FOS oligosaccharides /dl, to make up any shortfall in their own mother?s milk or as sole d

Sponsors

Milupa GmbH, Numico Research (Germany)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: 1. More than 72 hours exclusive parenteral nutrition 2. Immediately life-threatening congenital abnormality 3. Any condition requiring major surgery

Design outcomes

Primary

MeasureTime frame
1. Number of days from birth to reach a total (sole formula or formula with breast milk) daily enteral intake of 150 ml/kg 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

MeasureTime frame
1. Gain in weight, length and head circumference 2. Faecal flora 3. Faecal calprotectin 4. Faecal characteristics 5. Gastrointestinal tolerance 6. Fluid balance 7. Necrotising enterocolitis 8. Bloodstream infection

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 18, 2026