Premature Infant Clinical Trial
Official title:
Effects of Targeted Versus Adjustable Protein Fortification of Breast Milk on Early Growth in Very-low-birth-weight Preterm Infants: A Randomized Clinical Trial
Objectives: To compare the effects of two different methods of individualized protein
fortification of breast milk on the early growth of VLBW preterm infants.
Design: VLBW preterm infants ≤ 32 weeks of gestational age were included in the study and
randomized into two groups according to the method of breast milk fortification. In the
targeted protein fortification group, breast milk samples were analyzed daily via
mid-infrared spectroscopy and additional protein was provided to maintain an intake of 4.5
g/kg/day. In the adjustable protein fortification group, blood urea nitrogen (BUN) levels
were monitored weekly, and if the level was < 5 mg/dL, the amount of protein fortification
was gradually increased to an "estimated" maximum level of 4.5 g/kg/day, as per the policy of
neonatal intensive care unit. The cumulative amounts of protein, energy, fat, and
carbohydrate given to infants prior to study commencement and during the study period were
calculated. Anthropometric measurements were performed in both groups weekly for 4 weeks to
compare their growth, and blood data including pH, base deficit, and urea, creatinine, and
albumin levels were collected.
Optimal feeding during the early neonatal period is critical because inadequate nutrition,
especially of very-low-birth-weight (VLBW) preterm infants, causes growth restrictions and
has negative effects on neurocognitive development (1-5).
Although breast milk is the first choice for nutrition of preterm infants (6, 7), it falls
short of meeting all of the nutritional needs of VLBW infants unless fortified (8-10).
Therefore, standard fortification (addition of a fixed amount of a commercial fortifier to
breast milk) has become a commonly used method in neonatal intensive care units (NICUs) (11,
12). Standard fortification is performed based on assumptions made about the protein level in
breast milk. However, protein levels show inter- and intra-individual variation, and the
assumed levels in the milk of the mothers of preterm infants (2.1-2.4 g/100 kcal) is reduced
to <1.5 g/100 kcal after the 14th day of lactation (10, 13-17). The protein content of
commercial fortifiers ranges from 0.7 to 1.1 g/100 mL, and they thus can only increase the
amount of protein in breast milk to 3.25 g/100 kcal. Therefore, the standard fortification
method fails to meet the daily protein need of 3.5-4.5 g/kg/day of VLBW infants that is
recommended by the European Society for Pediatric Gastroenterology Hepatology and Nutrition
(18, 19).
Individualized fortification is another method recommended for optimizing breast milk
fortification, and it is considered the best solution for addressing the protein deficiencies
of VLBW preterm infants (10, 12). There are two valid methods of individualized
fortification: "targeted fortification" based on analyses of breast milk proteins, and
"adjustable fortification" based on the blood urea nitrogen (BUN) - reflected metabolic
response of infants (10, 12). Despite these developments, there is still no consensus on the
optimum fortification method; many different protocols are applied in NICUs worldwide (20,
21).
To the best of the investigators knowledge, no study has yet compared these two
individualized fortification methods for nutrition of preterm infants. Therefore, the
investigators compared the effects of targeted and adjustable protein fortification on the
early growth of breastfed VLBW preterm infants.
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