PrematurityNCT01208493
Dietary Protein in the Very-low-birth-weight Infant
A study testing preterm infant formula with high protein levels and preterm standard infant formula in people with Prematurity, run by Société des Produits Nestlé (SPN) at 4 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 1 day to 10 weeksHealthy volunteers can take part
- Conditions the study is for
- Prematurity
- What is being tested?
- preterm infant formula with high protein levels and preterm standard infant formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Sep 2007to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 10 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
United States1 site
Department of Pediatrics St Louis University
St Louis, Missouri, 63104
Belgium1 site
Service Universitaire de Néonatologie CHR de la Citadelle
Liège, 4000
United Kingdom1 site
Department of Child Health Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP
About this study
Official title: Dietary Protein in the Very-low-birth-weight Infant: Effects of the Level of Dietary Protein on Growth and Feeding Tolerance
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.
- Conditions
- Prematurity
- Being tested
- preterm infant formula with high protein levels, preterm standard infant formula
- Keywords
- prematurity, enteral feeding, proteins, formula
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preterm infant formula with high protein levelsOther
minimum 3 weeks feeding until hospital discharge
preterm standard infant formulaOther
minimum 3 weeks feeding until hospital discharge
| Study group | Role | What they receive |
|---|---|---|
| high protein preterm infant formula | Experimental | preterm infant formula with high protein levels Receives: Other: preterm infant formula with high protein levels |
| control preterm formula | Active comparator | Not described Receives: Other: preterm standard infant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of weight gain between both study groups as a measure of safety
Measured: 3 weeks
Secondary outcomes (1)
comparison of feeding tolerance and metabolic status between study groups as a measure of safety
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2010 (estimated)
- Study startSep 2007
- Primary completionDec 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard J Cooke, MD, Principal investigator, Department of Pediatrics St Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01208493
- Sponsor's protocol ID
- 04.26.INF
- Status last verified
- Dec 2011
- First submitted
- 22 Sep 2010
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Protein in the Very-low-birth-weight Infant: Effects of the Level of Dietary Protein on Growth and Feeding Tolerance
- ClinicalTrials.gov ID
- NCT01208493
- Acronym / sponsor ID
- 04.26.INF
- Conditions
- Prematurity
- Keywords
- prematurity, enteral feeding, proteins, formula
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 24 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high protein preterm infant formula | Experimental | Other: preterm infant formula with high protein levelspreterm infant formula with high protein levels |
| control preterm formula | Active comparator | Other: preterm standard infant formula |
Who may qualify
- Ages
- 1 day to 10 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| preterm infant formula with high protein levelsminimum 3 weeks feeding until hospital discharge | Other | high protein preterm infant formula |
| preterm standard infant formulaminimum 3 weeks feeding until hospital discharge | Other | control preterm formula |
Primary outcome
comparison of weight gain between both study groups as a measure of safety
Time frame: 3 weeks
1 secondary outcome
comparison of feeding tolerance and metabolic status between study groups as a measure of safety
Time frame: 3 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard J Cooke, MD principal investigator
Department of Pediatrics St Louis University
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preterm infant formula with high protein levels and preterm standard infant formula in people with Prematurity, run by Société des Produits Nestlé (SPN) at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Belgium, France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of weight gain between both study groups as a measure of safety (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2015.