Weight Gain Preterm Clinical Trial
Official title:
Strategy to Minimize In-hospital Malnutrition in Premature Babies
Adequate nutrition is important for preventing malnutrition in the postnatal period and thus
optimize growth and development of children born prematurely. To avoid malnutrition is
recommended to provide nutrients necessary for a growth rate similar to the intrauterine
life.
For nearly one decade studying how to minimize in-hospital malnutrition in children born
prematurely, especially with gestational age less than 32 weeks or with birth weight below
1,500 g, called newborn very low birth weight (VLBW).
Embleton et al.demonstrated that with the current nutritional recommendations (protein
between 3.0 and 3.8 g / kg / day), the VLBW had malnutrition caused by protein and calorie
cumulative deficit.
Poor nutrition in the neonatal period can impair growth and neuromotor and cognitive
development after hospital discharge.
The investigators hypothesis is that VLBW subjected to aggressive nutrition with
protein-calorie high from birth until discharge, would present higher weight gain than the
VLBW infants who received routine diet of service, without producing adverse effects.
The study used newborn with weight less than or equal to 1,500, at the University Hospital
Pedro Ernesto (HUPE) State University of Rio de Janeiro. Were defined as exclusion criteria
congenital malformations, genetic syndromes and death of the patient before inclusion in the
study. All children included in the study after written consent of those responsible,
received aggressive parenteral nutrition immediately after birth and minimal enteral feeding
in the first or second day of life. When the volume of enteral diet reached the value equal
to or greater than 100 ml / kg / day was suspended intravenous hydration or parenteral
nutrition. The increase of enteral nutrition was conducted in compliance with the gradual
increase of 20 ml / kg / day, according the acceptance of VLBW.The clinical trial was
randomized into two types of calorie intake in the diet. Newborn exposed group (EG) received
enteral diet with 4.5 g / kg / day of protein and 160cal/Kg/dia, and in the control group
(CG) was used usual diet with caloric intake from 3.5 to 4 g / kg / day of protein and
120-140 kcal / kg / day. The osmolality of the diet has not changed, there was an increase
in the volume to achieve the desired protein-caloric. We used two types of nutrition: 1) raw
milk milked exclusively at the bedside of VLBW (without fortifying additive); 2) milk
formula for premature exclusive. The type of feed was considered as exclusive breastfeeding
or exclusive formula for premature when there were more than 80% predominance of one type of
food. The food was offered initially by orogastric catheter until the child reaches maturity
to be fed by cup and / or suction.
The assessment was initiated when enteral feeding reached a volume exceeding 100 ml / kg /
day and was suspended concomitant intravenous infusion or nutrition parenteral total (NPT)
solution, and completed at discharge or at 43 weeks corrected gestational age, or in case of
death or shutdown of the project requested by those responsible.
The calculation of caloric intake and water was daily, were presumed to breast milk values
of 1.5 g of protein and 70 calorias/100 ml and in milk formula for premature infants used
are listed values of 2.3 g of protein and 80 calories per 100ml.The outcome measure will be
assessed when children have completed 43 weeks of corrected gestational age.
The sample size calculation assuming risk of 5%, 80% power and prevalence of 50% resulted in
60 newborn. Statistical analysis were measured average rates of weight and gestational age
at birth and at discharge, the average corrected age at discharge, the rate of SGA VLBW;
daily weight gain during the total days of hospitalization, the real weight gain during the
period between the day of recovery of birth weight and hospital discharge. Was also
calculated the difference between Z score of hospital discharge and birth for weight, length
and head circumference.
Statistical calculations were performed: Ficher exact test and / or odds ratio (OR) for
categorical variables, ANOVA or Kruskal-Wallis test for continuous variables. Was considered
when p <0.05 as statistically significant.
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care