PI Name | Protocol Number | Protocol Title |
Steven Abrams, Keli Hawthorne, Ian Griffin, Penni Hicks, Stefanie Rogers, Nancy Hurst | H-20560 | CALCIUM ABSORPTION IN NEONATES FED WITH MOTHER’S MILK FORTIFIED WITH A DONOR HUMAN MILK FORTIFIER |
Background Info |
Breast milk is considered the nutrition of choice for infants, including premature infants in the Neonatal ICU. In the case of very low birth weight infants, this milk is generally supplemented with a human milk fortifier (HMF). |
Hypothesis |
The use of a HMF made from pasteurized donor human milk will provide adequate calcium absorption, growth, and bone mineralization to preterm infants. |
Design |
Infants will receive mother’s own milk fortified with Prolact-plus, a pasteurized donor human milk fortifier that was recently developed. Control Cohort will be made up of infants fed mother's own milk fortified with a standard cow's milk based fortifier, which is routinely provided to premature infants. After 2 weeks of full volume feeds, the subject will have a calcium absorption study using calcium stable isotopes. The subject will continue on the study diet for an additional 4 weeks. |
Sample
size
|
Sample size (n = 15) was chosen such that a significant difference in intake-adjusted fractional calcium absorption of 11% could be identified (null hypothesis being accepted would be < 11% difference). Using a beta of 0.8, and alpha of 0.05, the estimated n = 13. We will recruit 15 subjects to account for attrition. |
Entry criteria |
1) Delivery at 25-32 6/7 weeks gestation by best estimate from maternal dates, prenatal U/S and newborn exam AND Birth weight of 700-1799 g, (2) Admitted/transferred to TCH by 30d of age, and (3) Parental intention to provide mother’s own milk. |
Results/conclusions
to date |
We have completed the 6-wk study in 1 infant. We have 6 more infants currently enrolled in the study. We have no conclusions or interim data to report at this time. |