Strategy to Minimize In-hospital Malnutrition in Premature Babies

NCT ID: NCT01217164

Last Updated: 2010-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2010-06-30

Brief Summary

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.

Detailed Description

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.

Conditions

Weight Gain Preterm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

higher protein

Group Type: NO_INTERVENTION

no intervention

Intervention Type: DIETARY_SUPPLEMENT

received enteral diet with 4.5 g / kg / day of protein and 160cal/Kg/dia

Interventions

no intervention

received enteral diet with 4.5 g / kg / day of protein and 160cal/Kg/dia

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Feeding preterm; Very low birth weight; weight gain; neurodevelopment

Eligibility Criteria

Inclusion Criteria

• All very low birth weight infant after written consent of those responsible

Exclusion Criteria

• congenital malformations, genetic syndromes and death

• Maximum Eligible Age: 43 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Universitario Pedro Ernesto

OTHER

Sponsor Role: lead

Responsible Party

Faculdade de Ciencias Médicas, UERJ

Principal Investigators

Jose L Duarte

Role: PRINCIPAL_INVESTIGATOR

State University of Rio de Janeiro

Locations

Jose Luiz Muniz Bandeira Duarte

Rio de Janeiro, Rio de Janeiro, Brazil

Countries

Brazil

References

Ehrenkranz RA, Younes N, Lemons JA, Fanaroff AA, Donovan EF, Wright LL, Katsikiotis V, Tyson JE, Oh W, Shankaran S, Bauer CR, Korones SB, Stoll BJ, Stevenson DK, Papile LA. Longitudinal growth of hospitalized very low birth weight infants. Pediatrics. 1999 Aug;104(2 Pt 1):280-9. doi: 10.1542/peds.104.2.280.

Reference Type: RESULT

PMID: 10429008 (View on PubMed)

Related Links

http://www.hupe.uerj.br

university hospital ou state university of rio de janeiro

Other Identifiers

DUARTEJLMB-001

Identifier Type: -

Identifier Source: org_study_id