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Dietary Protein in the Very-low-birth-weight Infant

Primary Purpose

Prematurity

Status

Terminated

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

preterm infant formula with high protein levels

preterm standard infant formula

About this trial

This is an interventional treatment trial for Prematurity focused on measuring prematurity, enteral feeding, proteins, formula

Eligibility Criteria

1 Day - 10 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Gestational age <32 w, determined by maternal dates, fetal ultrasound, Dubowitz/Ballard examination or a combination thereof
Birth weight ≤1500 g
Tolerating an enteral intake of ≥100 ml/kg/d for ≥ 24 h
Subject is anticipated to receive the study formula for ≥ 3 consecutive weeks after FEF have been achieved
In infants fed human milk, formula is anticipated to provide 50% or more of total energy intake, calculated on a weekly basis and based on the assumption that human milk has an energy density of 67 kcal/dl
Written informed consent has been obtained from the legal representative

Exclusion Criteria:

Cardiac failure requiring fluid restriction with diuretic therapy for ≥ 3 consecutive days
Peri-/intra-ventricular haemorrhage (grade 3-4) determined using cranial ultrasonography
Renal disease: by symptoms (oliguria, anuria, proteinuria, hematuria) associated with an increased BUN and creatinine
Sepsis: defined by symptoms requiring antibiotic therapy and confirmed by a positive blood culture
Necrotizing Enterocolitis: defined by feeding intolerance associated with positive x-ray findings (pneumatosis intestinalis - Bell Stage 2; air in the biliary tract or free air in the peritoneum - Bell Stage 3)
Hepatic dysfunction: defined by jaundice (direct bilirubin >1.0 mg/dl) which is associated with one or more abnormal liver function tests (AST, ALT or GGT)
Lung disease, severe enough to require steroid therapy.
Small size for gestational age (SGA) - body weight ≤ 5th percentile for that gestational age.
Participation in another clinical trial that may affect outcomes of this study

Sites / Locations

Department of Pediatrics St Louis University
Service Universitaire de Néonatologie CHR de la Citadelle
Service de néonatologie Hôpital de la Croix Rousse
Department of Child Health Royal Victoria Infirmary

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

high protein preterm infant formula

control preterm formula

Arm Description

preterm infant formula with high protein levels

Outcomes

Primary Outcome Measures

comparison of weight gain between both study groups as a measure of safety

Secondary Outcome Measures

comparison of feeding tolerance and metabolic status between study groups as a measure of safety

Full Information

NCT ID

NCT01208493

First Posted

September 22, 2010

Last Updated

March 25, 2015

Sponsor

Société des Produits Nestlé (SPN)

1. Study Identification

Unique Protocol Identification Number

NCT01208493

Brief Title

Dietary Protein in the Very-low-birth-weight Infant

Official Title

Dietary Protein in the Very-low-birth-weight Infant: Effects of the Level of Dietary Protein on Growth and Feeding Tolerance

Study Type

Interventional

2. Study Status

Record Verification Date

December 2011

Overall Recruitment Status

Terminated

Study Start Date

September 2007 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Société des Produits Nestlé (SPN)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

In this randomized study The investigators aim to compare the growth of very-low-birth-weight (VLBW) infants fed either a high protein or a standard protein preterm infant formula. Babies will be fed the assigned formula between the time they achieve full enteral feeds and hospital discharge, for a minimum of 3 weeks. The weight gain (g/d) will be measured and compared between groups. Feeding tolerance, protein-energy status and body composition between the study groups will also be analysed. After discharge, babies will be fed a post-discharge preterm infant formula (PDF) between hospital discharge and 3 m corrected age.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prematurity

Keywords

prematurity, enteral feeding, proteins, formula

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

high protein preterm infant formula

Arm Type

Experimental

Arm Description

preterm infant formula with high protein levels

Arm Title

control preterm formula

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

preterm infant formula with high protein levels

Intervention Description

minimum 3 weeks feeding until hospital discharge

Intervention Type

Other

Intervention Name(s)

preterm standard infant formula

Intervention Description

minimum 3 weeks feeding until hospital discharge

Primary Outcome Measure Information:

Title

comparison of weight gain between both study groups as a measure of safety

Time Frame

3 weeks

Secondary Outcome Measure Information:

Title

comparison of feeding tolerance and metabolic status between study groups as a measure of safety

Time Frame

3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Day

Maximum Age & Unit of Time

10 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Gestational age <32 w, determined by maternal dates, fetal ultrasound, Dubowitz/Ballard examination or a combination thereof Birth weight ≤1500 g Tolerating an enteral intake of ≥100 ml/kg/d for ≥ 24 h Subject is anticipated to receive the study formula for ≥ 3 consecutive weeks after FEF have been achieved In infants fed human milk, formula is anticipated to provide 50% or more of total energy intake, calculated on a weekly basis and based on the assumption that human milk has an energy density of 67 kcal/dl Written informed consent has been obtained from the legal representative Exclusion Criteria: Cardiac failure requiring fluid restriction with diuretic therapy for ≥ 3 consecutive days Peri-/intra-ventricular haemorrhage (grade 3-4) determined using cranial ultrasonography Renal disease: by symptoms (oliguria, anuria, proteinuria, hematuria) associated with an increased BUN and creatinine Sepsis: defined by symptoms requiring antibiotic therapy and confirmed by a positive blood culture Necrotizing Enterocolitis: defined by feeding intolerance associated with positive x-ray findings (pneumatosis intestinalis - Bell Stage 2; air in the biliary tract or free air in the peritoneum - Bell Stage 3) Hepatic dysfunction: defined by jaundice (direct bilirubin >1.0 mg/dl) which is associated with one or more abnormal liver function tests (AST, ALT or GGT) Lung disease, severe enough to require steroid therapy. Small size for gestational age (SGA) - body weight ≤ 5th percentile for that gestational age. Participation in another clinical trial that may affect outcomes of this study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard J Cooke, MD

Organizational Affiliation

Department of Pediatrics St Louis University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Pediatrics St Louis University

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63104

Country

United States

Facility Name

Service Universitaire de Néonatologie CHR de la Citadelle

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Service de néonatologie Hôpital de la Croix Rousse

City

Lyon

ZIP/Postal Code

69317

Country

France

Facility Name

Department of Child Health Royal Victoria Infirmary

City

Newcastle upon Tyne

ZIP/Postal Code

NE1 4LP

Country

United Kingdom

12. IPD Sharing Statement

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Dietary Protein in the Very-low-birth-weight Infant

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