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

Nestlé

Status

Terminated

Conditions

Prematurity

Treatments

Other: preterm standard infant formula

Other: preterm infant formula with high protein levels

Study type

Interventional

Funder types

Industry

Identifiers

NCT01208493

04.26.INF

Details and patient eligibility

About

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.

Enrollment

70 patients

Sex

All

Ages

1 day to 10 weeks old

Volunteers

Accepts 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