A randomised, double-blind, controlled trial to evaluate the effects of a new human milk fortifier on growth and tolerance in preterm infants.
Phase 2
Completed
- Conditions
- vroeggeboorte, laag geboortegewichtPreterm infants with very low birth weight (<1500g)
- Registration Number
- NL-OMON50533
- Lead Sponsor
- utricia Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 75
Inclusion Criteria
1. Preterm infants fed own mother*s milk (or donor human milk) in need of a HMF
(as decided by the investigator)
2. Gestational age <32 weeks and birth weight <1500 g
3. Receiving enteral feeding
4. Expected to be in need of a HMF for minimally 21 days
5. Written informed consent from custodial parent(s)
Exclusion Criteria
1. Any relevant proven or suspected chromosomal anomaly, metabolic disorder,
genetic syndrome or congenital central nervous system malformation
2. Presence or history of any gastrointestinal malformation/compromise,
including Necrotising enterocolitis (NEC) (defined as Bell*s stage two or
higher)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Weight growth velocity (in g/kg/day) from baseline to study day 21.</p><br>
- Secondary Outcome Measures
Name Time Method <p>During the intervention period:<br /><br>- Growth (length, head circumference and anthropometric Z-scores<br /><br>- Gastro-intestinal tolerance (stools, data on enteral feeding,<br /><br>vomiting/regurgitation)</p><br>