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
Verified date | October 2017 |
Source | Istanbul University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | February 28, 2014 |
Est. primary completion date | December 1, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Weeks to 32 Weeks |
Eligibility |
Inclusion Criteria: - Very-low-birth-weight preterm infants = 32 weeks of gestational age who were fed exclusively fortified breast milk. Exclusion Criteria: - The exclusion criteria were any congenital abnormality, a metabolic disease, necrotizing enterocolitis, bronchopulmonary dysplasia, and feeding with formula or formula plus breast milk. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Ozgul Bulut |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Weight gain | The mean of weight gain (g/kg/day) | 4 weeks | |
Primary | Head circumference | The mean of head circumference (mm/week) | 4 weeks | |
Primary | Length | The mean of length (mm/week) | 4 weeks | |
Secondary | Blood Urea Nitrogen (BUN) | The mean of BUN (mg/dL) | 4 weeks | |
Secondary | Albumin | The mean of albumin (g/dL) | 4 weeks | |
Secondary | Base deficit | The mean of base deficit (mEq/L) | 4 weeks | |
Secondary | Protein content | The mean of total daily intake of protein (g/kg/day) | 4 weeks | |
Secondary | Calorie intake | The mean of total daily intake of calorie (kcal/kg/day) | 4 weeks | |
Secondary | Carbonhydrate content | The mean of total daily intake of carbohydrate (g/kg/day) | 4 weeks | |
Secondary | Lipid content | The mean of total daily intake of lipid (g/kg/day) | 4 weeks | |
Secondary | Protein/Energy Ratio | The mean of total daily intake of Protein\Energy Ratio | 4 weeks |
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