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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2012-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects (Long Term Analysis) of an Hyperproteinic Nutrition on Neonates With Intra-uterine Growth Delay : a Prospective, Multicentric , Randomized, Double Blind Study ("Proneonat")

NCT00764179

Intra-uterine Growth Delay

TERMINATED NA

Protein for Premies

NCT01773902

Extreme Prematurity

COMPLETED NA

Effect of the Level of Dietary Protein on Infant Growth

NCT00716105

Infant Nutrition

COMPLETED NA

Targeted Protein Fortification in Extremely Low Birth Weight Preterm Infants

NCT02943746

Premature Infants

COMPLETED NA

Neurodevelopmental and Growth Outcomes of Early, Aggressive Protein Intake in Very Low Birthweight Infants

NCT01860573

Prematurity

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prematurity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

high protein preterm infant formula

preterm infant formula with high protein levels

Group Type EXPERIMENTAL

preterm infant formula with high protein levels

Intervention Type OTHER

minimum 3 weeks feeding until hospital discharge

control preterm formula

Group Type ACTIVE_COMPARATOR

preterm standard infant formula

Intervention Type OTHER

minimum 3 weeks feeding until hospital discharge

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

preterm infant formula with high protein levels

minimum 3 weeks feeding until hospital discharge

Intervention Type OTHER

preterm standard infant formula

minimum 3 weeks feeding until hospital discharge

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

1 Day

Maximum Eligible Age

10 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes