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

Primary Purpose

Weight Gain Preterm

Status
Completed
Phase
Early Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
no intervention
Sponsored by
Hospital Universitario Pedro Ernesto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Weight Gain Preterm focused on measuring nutrition, very low birth weight, premature

Eligibility Criteria

undefined - 43 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • congenital malformations, genetic syndromes and death

Sites / Locations

  • Jose Luiz Muniz Bandeira Duarte

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

higher protein

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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)

Full Information

First Posted
August 27, 2010
Last Updated
October 7, 2010
Sponsor
Hospital Universitario Pedro Ernesto
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1. Study Identification

Unique Protocol Identification Number
NCT01217164
Brief Title
Strategy to Minimize In-hospital Malnutrition in Premature Babies
Acronym
SPN
Official Title
Strategy to Minimize In-hospital Malnutrition in Premature Babies
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Universitario Pedro Ernesto

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Gain Preterm
Keywords
nutrition, very low birth weight, premature

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
higher protein
Arm Type
No Intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
no intervention
Other Intervention Name(s)
Feeding preterm, Very low birth weight, weight gain, neurodevelopment
Intervention Description
received enteral diet with 4.5 g / kg / day of protein and 160cal/Kg/dia
Primary Outcome Measure Information:
Title
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
Description
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).
Time Frame
The cutoff point for the measurement of weight was discharged or until 43 weeks corrected gestational age if prolonged hospitalization.
Secondary Outcome Measure Information:
Title
The difference between score Z (birth weight) and score Z (weight during discharge).
Description
Measurements of the Z score corresponding to the birth weight and weight were discharged through the growth curve of the WHO (2006)
Time Frame
The cutoff point for the measurement of weight was discharged or until 43 weeks corrected gestational age if prolonged hospitalization.

10. Eligibility

Sex
All
Maximum Age & Unit of Time
43 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All very low birth weight infant after written consent of those responsible Exclusion Criteria: congenital malformations, genetic syndromes and death
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose L Duarte
Organizational Affiliation
State University of Rio de Janeiro
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jose Luiz Muniz Bandeira Duarte
City
Rio de Janeiro
ZIP/Postal Code
22793-266
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
10429008
Citation
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.
Results Reference
result
Links:
URL
http://www.hupe.uerj.br
Description
university hospital ou state university of rio de janeiro

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Strategy to Minimize In-hospital Malnutrition in Premature Babies

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