Effect of donor human milk on severe infections and mortality in VLBW infants, a double blind randomized controlled trial
Recruiting
- Conditions
- infections100179661000401810016950
- Registration Number
- NL-OMON39540
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 396
Inclusion Criteria
birth weight < 1500 gram
Exclusion Criteria
- Child of mother that abused drugs and/or alcohol during pregnancy
- Major congenital anomalies or birth defects
- Suspected congenital infection
- Perinatal asphyxia with (umbilical or first neonatal) pH < 7.0
- Intake of any cow*s milk based products prior to randomization
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Combined incidence of serious infections/NEC and death.<br /><br><br /><br>Amendement ESS:<br /><br>- Bone density as determined by DXA at term corrected age for infants from VUmc<br /><br>and the UMCN.<br /><br><br /><br>Amendement Adrenocortical funtion:<br /><br>- Production and metabolism of cortisol at ages 10 and 30 days, in infants in<br /><br>VUmc.<br /><br>- Physiological responses (hart rate, saturation and respiratory rate)<br /><br>following a 35 dB stimulus (ALGO test), in infants from VUmc.<br /><br><br /><br>Amendement Body Composition:<br /><br>- Body composition at corrected age of 1, 2 and 5 years measured with air<br /><br>displacement plethysmography (ADP) en deuterium dilusion in infants from VUmc<br /><br>and AMC.<br /><br>- Relation between the timing of introduction and the composition of<br /><br>complementary feeding and body composition. </p><br>
- Secondary Outcome Measures
Name Time Method