GrowthNCT01162798
Preterm Infant Growth
A study testing infant formula in people with Growth and Development, run by Société des Produits Nestlé (SPN) at 9 sites in United States.
Trial summary
The purpose of this study is to assess growth of preterm infants fed a test formula compared to a standard formula up to the first 4 months of corrected gestational age. Read more about this study
- Who is it for?
- Ages Up to 1 month
- Conditions the study is for
- Growth, Development, Infant
- What is being tested?
- infant formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 9 sitesUnited States
- Study dates
- Sep 2010to Sep 2014
- 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 Up to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Born AGA
- Exclusively formula-fed
- 28-34 weeks GA at birth
- Intact GI tract, tolerating full oral feeds
- Expected to be discharged from the hospital within a minimum of 24 hours, maximum of 5 days
Who cannot join
- Severe respiratory disease defined as needing mechanical ventilation at discharge
- Any significant systemic diseases that could affect growth. This includes cardiac, neurologic, or GI conditions.
- Major congenital malformation, history of GI surgery, severe postnatal complications
- Daily or routine diuretic use at time of discharge
- Receiving more than 10% of daily kcals from food additives such as thickeners
- Currently participating or having participated in another conflicting clinical trial.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
Nationwide Children's Hospital
Columbus, Ohio, 43205
University of Iowa
Iowa City, Iowa, 52241
Midatlantic Neonatology Associates, Inc
Morristown, New Jersey, 07962
Children's Hospital & Research Center
Oakland, California
Center for Human Nutrition
Omaha, Nebraska, 68105
Advocate Lutheran Children's Hospital
Park Ridge, Illinois
VCU Children's Medical Center
Richmond, Virginia, 23298
University of Utah, Dept of Pediatrics
Salt Lake City, Utah, 84108
About this study
Official title: Growth of Preterm Infants Consuming Formula
The purpose of this study is to assess growth of preterm infants fed a test formula compared to a standard formula up to the first 4 months of corrected gestational age.
- Conditions
- Growth, Development, Infant
- Being tested
- infant formula, control infant formula
- Keywords
- infant formula, premature infants, Growth and Development
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infant formulaOther
Also called test infant formula
test infant formula fed to infants until 6 months corrected gestational age
control infant formulaOther
Also called commercially available infant formula fed to infants until 6 months corrected gestational age
commercially available infant formula
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | commercially available formula Receives: Other: control infant formula |
| Test | Experimental | test formula Receives: Other: infant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth
weight gain assessed monthly
Measured: 4 months
Secondary outcomes (2)
growth, tolerance, morbidity
gains in length and head circumference assessed monthly, tolerance and morbidity throughout study
Measured: 6 months
Total body bone mineral content and density and body composition, protein status, and metabolic markers
Measured: corrected term and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2010 (estimated)
- Study startSep 2010
- Primary completionOct 2013
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GrowthStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ekhard Ziegler, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01162798
- Sponsor's protocol ID
- 09.02.US.INF
- Status last verified
- Nov 2014
- First submitted
- 13 Jul 2010
- Last updated
- 4 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth of Preterm Infants Consuming Formula
- ClinicalTrials.gov ID
- NCT01162798
- Acronym / sponsor ID
- 09.02.US.INF
- Conditions
- Growth, Development, Infant
- Keywords
- infant formula, premature infants, Growth and Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 15 Jul 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.
The purpose of this study is to assess growth of preterm infants fed a test formula compared to a standard formula up to the first 4 months of corrected gestational age.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: control infant formulacommercially available formula |
| Test | Experimental | Other: infant formulatest formula |
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Born AGA
- Exclusively formula-fed
- 28-34 weeks GA at birth
- Intact GI tract, tolerating full oral feeds
- Expected to be discharged from the hospital within a minimum of 24 hours, maximum of 5 days
Key exclusion criteria (6 listed)
- Severe respiratory disease defined as needing mechanical ventilation at discharge
- Any significant systemic diseases that could affect growth. This includes cardiac, neurologic, or GI conditions.
- Major congenital malformation, history of GI surgery, severe postnatal complications
- Daily or routine diuretic use at time of discharge
- Receiving more than 10% of daily kcals from food additives such as thickeners
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 |
|---|---|---|
| infant formulaAlso: test infant formulatest infant formula fed to infants until 6 months corrected gestational age | Other | Test |
| control infant formulaAlso: commercially available infant formula fed to infants until 6 months corrected gestational agecommercially available infant formula | Other | Control |
Primary outcome
Growth
Time frame: 4 months
weight gain assessed monthly
2 secondary outcomes
growth, tolerance, morbidity
Time frame: 6 months
Total body bone mineral content and density and body composition, protein status, and metabolic markers
Time frame: corrected term and 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2014.
Related trials for Growth
RecruitingPhase 1/2
A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer
Breast Cancer
Recruiting
A Clinical Trial to Evaluate the Effects of a Children's Daily Multivitamin on Perceived Growth, Immune Health, Energy, and Focus in Children
Nutrient Gap in Children, Pediatric Health and Well-Being
Enrolling by invitationPhase 2
Extension Study of Infigratinib in Children With Achondroplasia (ACH)
Achondroplasia
Not yet recruiting
PROfiles of FGF-19 Post-prandial Secretion in Older Adults With Frailty and Without Frailty
Frailty, Sarcopenia
RecruitingPhase 2
Study of REGN13335 in Adult Participants With Pulmonary Arterial Hypertension (PAH)
Pulmonary Arterial Hypertension (PAH)
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.
Ekhard Ziegler, MD principal investigator
University of Iowa
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing infant formula in people with Growth and Development, run by Société des Produits Nestlé (SPN) at 9 sites in United States.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 4 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Growth (time frame: 4 months). 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 4 Nov 2014.