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

Prematurity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01208493
• Other study ID #: 04.26.INF
• Status: Terminated
• Phase: N/A
• First received: September 22, 2010
• Last updated: March 25, 2015
• Start date: September 2007
• Est. completion date: April 2012

Study information

• Verified date: December 2011
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: April 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 10 Weeks

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Birth Weight
• Premature Birth
• Prematurity

Intervention

Other:
• preterm infant formula with high protein levels
minimum 3 weeks feeding until hospital discharge
• preterm standard infant formula
minimum 3 weeks feeding until hospital discharge

Locations

Country	Name	City	State
Belgium	Service Universitaire de Néonatologie CHR de la Citadelle	Liège
France	Service de néonatologie Hôpital de la Croix Rousse	Lyon
United Kingdom	Department of Child Health Royal Victoria Infirmary	Newcastle upon Tyne
United States	Department of Pediatrics St Louis University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Countries where clinical trial is conducted

United States,  Belgium,  France,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comparison of weight gain between both study groups as a measure of safety		3 weeks	No
Secondary	comparison of feeding tolerance and metabolic status between study groups as a measure of safety		3 weeks	No