SUPFOR breast milk study: a randomised controlled trial in preterm infants receiving expressed breast milk comparing the use of breast milk fortification versus supplementation using a preterm formula
Not Applicable
Completed
- Conditions
- utrition in preterm infantsNutritional, Metabolic, EndocrinePreterm nutrition
- Registration Number
- ISRCTN92790284
- Lead Sponsor
- ewcastle Hospitals NHS Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
1. Preterm infants (less than 35 weeks gestation)
2. Receiving maternal breast milk
Exclusion Criteria
Infants who have already received fortification or supplementation (except where this was used in place of inadequate breast milk supply).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Weight gain (g/day) during initial hospital stay, measured three times a week<br>2. Length gain (mm/week) and head growth (mm/week) during initial hospital stay, measured once a week<br>3. Duration and amount of breast milk provided, measured daily
- Secondary Outcome Measures
Name Time Method 1. Maternal satisfaction, measured weekly and then at discharge<br>2. Incidence of abnormal biochemistry, measured when samples are taken - usually once a week