Strategy to Minimize In-hospital Malnutrition in Premature Babies (SPN)

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.

Study Overview

• Status: Completed
• Conditions: Weight Gain Preterm
• Intervention / Treatment: Dietary supplement: no intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 22793-266
    • Jose Luiz Muniz Bandeira Duarte

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 9 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• congenital malformations, genetic syndromes and death

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: higher protein	Dietary supplement: no intervention; received enteral diet with 4.5 g / kg / day of protein and 160cal/Kg/dia; Other Names: Feeding preterm; Very low birth weight; weight gain; neurodevelopment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The total of 64 children was followed from birth until discharge or death. The main outcome measured was weight gain during hospitalization or up to a maximum of 43 weeks gestational age when the child remained hospitalized	The results measured were: 1- the real gain in weight (weight gain during hospitalization days divided by the number of days between birth weight recovery until discharge day or time he turned 43 weeks corrected gestational age). 2 - The weight gain during hospitalization (weight gain during hospitalization divided by the number of days between the day of birth until the day of discharge).	The cutoff point for the measurement of weight was discharged or until 43 weeks corrected gestational age if prolonged hospitalization.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The difference between score Z (birth weight) and score Z (weight during discharge).	Measurements of the Z score corresponding to the birth weight and weight were discharged through the growth curve of the WHO (2006)	The cutoff point for the measurement of weight was discharged or until 43 weeks corrected gestational age if prolonged hospitalization.

Collaborators and Investigators

• Sponsor: Hospital Universitario Pedro Ernesto
• Investigators: Principal Investigator: Jose L Duarte, State University of Rio de Janeiro

Publications and helpful links

General Publications

• 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.

Helpful Links

• university hospital ou state university of rio de janeiro

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: August 27, 2010
• First Submitted That Met QC Criteria: October 7, 2010
• First Posted (Estimate): October 8, 2010

Study Record Updates

• Last Update Posted (Estimate): October 8, 2010
• Last Update Submitted That Met QC Criteria: October 7, 2010
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Keywords: nutrition; premature; very low birth weight
• Additional Relevant MeSH Terms: Nutrition Disorders; Body Weight; Pregnancy Complications; Obstetric Labor Complications; Body Weight Changes; Obstetric Labor, Premature; Premature Birth; Malnutrition; Weight Gain
• Other Study ID Numbers: DUARTEJLMB-001