Premature Birth Clinical Trial
Official title:
Evaluation of Additional Protein Fortification in Extremely Low Birth Weight Infants Fed Human Milk: PROTSUP Study
Postnatal growth is a crucial in premature infants as it could be correlated with the
long-term cognitive development. Optimal nutritional care is required to reduce the initial
weight loss and further growth deficit.
The quantitative objective is to achieve growth that is at least equivalent to that of the
fetus (on average 15 g/kg.day (12-18 g/kg.day according to gestational age). Children often
grow during difficult 10-15 first days of life, so they accumulate a delay that should
compensate them secondarily. Therefore, optimum postnatal growth is rather 20 g/kg.day than
15 g/kg.day.
Individualized fortification of human milk (HM) has been proposed to optimize postnatal
growth. Specifically, the lack of protein intake is responsible for sub-optimal postnatal
growth in preterm infants.
The objectives of this study are to determine the effectiveness of additional protein
fortification (APF) in terms of short-term growth along with the proportion of extremely low
birth weight (ELBW) infants requiring APF.
In a retrospective, single-center study, premature infants weighing <1250 g at birth
hospitalized in investigators' neonatal intensive care unit in 2012, who were exclusively
fed with fortified HM and received APF for >12 consecutive days were included.
Weight gain (g/kg•d) over the previous 7 days was calculated daily based on weight data in
patients' electronic medical records. When weight gain was considered insufficient (i.e.,
below 20 g/kg•d) and the serum urea level was <3 mmol/L, 1 g/kg•d protein was added. Before
using the mixture, investigators verified that the osmolality was only slightly increased
(from 412 to 422 mOsm/kg).
Growth and digestive tolerance were compared between the week before (Wk0) and 1 and 2 weeks
after (Wk1 and Wk2, respectively) the introduction of protein supplement; each participant
served as his own control. Change from baseline for body weight was the main outcome. Energy
and protein intake during Wk0, Wk1, and Wk2 were calculated. Standard deviation z-scores for
growth parameters were calculated 7 days before, at time of protein introduction, and 7 and
14 days after . Changes in Z-scores were calculated. The digestive tolerance score and
metabolic tolerance (serum urea) were assessed during Wk0, Wk1, and Wk2 (5).
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Observational Model: Cohort, Time Perspective: Retrospective
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