Improving the growth and development of preterm infants.Comparison of a fortifier prepared from donor breast milk with standard fortifiers used in routine practice. - A multicenter, randomized, clinical trial
Not Applicable
- Conditions
- Postnatal growth restriction, feeding tolerance
- Registration Number
- DRKS00032175
- Lead Sponsor
- Paracelsus Medizinische Privatuniversität, Klinikum Nürnberg, Klinik für Neugeborene, Kinder und Jugendliche
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 240
Inclusion Criteria
Preterm infants receiving fortified breast milk.
Exclusion Criteria
-Gastrointestinal malformation, severe congenital anomalies, and chromosomal abnormalities;
-Preterm infants with enterostomy or short bowel syndrome;
-Sepsis - All infants with gram-negative sepsis are excluded for per protocol analysis.
-Necrotizing enterocolitis defined by food intolerance associated with positive radiographic findings (pneumatosis intestinalis - Bell stage 2; air in the biliary tract or free air in the peritoneum - Bell stage 3).
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Weight measured with a scale at a postmenstrual age of 36 weeks
- Secondary Outcome Measures
Name Time Method Growth, nutritional intake, feeding tolerance, clinical chemstry, morbidity, length of stay