Premature Birth
Conditions
Keywords
growth, oral feeding, nutrition
Brief summary
Double-blind randomized controlled trial to investigate the impact of two human milk fortifiers on acid-base status and longitudinal growth and weight gain in preterm infants. Two different compositions are tested, main difference is in electrolyte composiiton.
Detailed description
Two groups each consisting of 15 infants with a birth weight below 2000g are studied.randomization is startified by three birth weigth classes (\<1000g, 1000-1500g,1500 - 2000g) human milk fortifier is introduced in two steps after oral feeding is achieved. two acid-base status and electrolyte concentrations are measured. when metabolic acidosis, defined as BE \< -6 mmol/l, occurs fortifier feeding is stopped, and after a wash-out period of three days the alternative product is used.again, occurence of metabolic acidosis, need for oral bicarbonate and effect on longitudinal growth an weight gain are registered.
Interventions
DRUGchanging of fortifier
Sponsors
NUMICO,Dr. Heike Mueller, Friedrichsdorf, Germany
University Medicine Greifswald
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
10 Days to 3 Months
Healthy volunteers
No
Inclusion criteria
growing premature infants with a birth weight \< 2000g
Exclusion criteria
congenital malformation chromosomal disorders sepsis metabolic disorders need for mechanical ventilation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| frequency of metabolic acidosis | — |
Secondary
| Measure | Time frame |
|---|---|
| need for oral bicarbonate administartion | — |
| longitudinal growth | — |
| weight gain | — |
| amino acid levels in plasma an urine | — |
Countries
Germany
Contacts
Primary ContactChristoph Fusch, Professor
Backup ContactJens Rochow, MD
Outcome results
None listed