Preterm InfantsPhase 3NCT00707837
Nutritional Study in Preterm Infants
A Phase 3 study testing Preterm infant formulas and discharge formulas and Preterm infant formula with added soluble lipids in people with Preterm Infants, run by Abbott Nutrition at 8 sites in United States.
Trial summary
An evaluation of a preterm infant formula containing ingredients similar to those found in breastmilk Read more about this study
- Who is it for?
- Ages Up to 21 days
- Conditions the study is for
- Preterm Infants
- What is being tested?
- Preterm infant formulas and discharge formulas and Preterm infant formula with added soluble lipids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 8 sitesUnited States
- Study dates
- May 2005to Aug 2008
- Phase
- Phase 3
- 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 21 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birthweight 500-1800 g
- Less than 33 wks gestational age
- Enteral feeding initiated by 21 days of life
- Asymmetrical small-for-gestational age (SGA) infants and infants with patent ductus arteriosus (PDA) are eligible to participate
- Singleton or twin births only
- Infant is 21 days of age or less at time of randomization
Who cannot join
- Serious congenital abnormalities that may affect growth and development
- Grade III or IV intraventricular hemorrhage (IVH)
- Maternal incapacity
- History of major surgery
- Extracorporeal membrane oxygenation (ECMO)
- Asphyxia
- Confirmed NEC or positive blood cultures at the time of randomization
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Alabama
Birmingham, Alabama, 35233
MetroHealth Medical Center
Cleveland, Ohio, 44109
University of Louisville
Louisville, Kentucky, 40202
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
University of Utah
Salt Lake City, Utah, 84132
West Coast Neonatalogy, All Children's Hospital
St. Petersburg, Florida, 33701
University of South Florida
Tampa, Florida, 33606
Maria Fareri Children's Hospital at Winchester Medical Center
Vahalla, New York, 10595
About this study
Official title: Effect of Supplemental Infant Formula on Blood Levels in Preterm Infants
An evaluation of a preterm infant formula containing ingredients similar to those found in breastmilk
- Conditions
- Preterm Infants
- Being tested
- Preterm infant formulas and discharge formulas, Preterm infant formula with added soluble lipids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preterm infant formulas and discharge formulasOther
Preterm infant formulas to be consumed per health care provider orders
Preterm infant formula with added soluble lipidsOther
Preterm infant formula to be fed per healthcare provider instructions
| Study group | Role | What they receive |
|---|---|---|
| Infant Formula | Experimental | Preterm infant formulas containing lipid soluble compounds Receives: Other: Preterm infant formula with added soluble lipids |
| Preterm formulas | Active comparator | Standard preterm infant formula and discharge formulas Receives: Other: Preterm infant formulas and discharge formulas |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to compare the serum concentrations of fat soluble compounds in preterm infants fed a regimen of preterm formulas and in human milk fed infants
Measured: variable
Secondary outcomes (1)
Measures of eye function, ROP, measures of skin lipid soluble compound concentration
Measured: variable
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2008 (estimated)
- Study startMay 2005
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bridget Barrett-Reis, PhD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00707837
- Sponsor's protocol ID
- AK15
- Status last verified
- Sep 2008
- First submitted
- 27 Jun 2008
- Last updated
- 27 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Supplemental Infant Formula on Blood Levels in Preterm Infants
- ClinicalTrials.gov ID
- NCT00707837
- Acronym / sponsor ID
- AK15
- Conditions
- Preterm Infants
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 1 Jul 2008 (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.
An evaluation of a preterm infant formula containing ingredients similar to those found in breastmilk
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 |
|---|---|---|
| Infant Formula | Experimental | Other: Preterm infant formula with added soluble lipidsPreterm infant formulas containing lipid soluble compounds |
| Preterm formulas | Active comparator | Other: Preterm infant formulas and discharge formulasStandard preterm infant formula and discharge formulas |
Who may qualify
- Ages
- Up to 21 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Birthweight 500-1800 g
- Less than 33 wks gestational age
- Enteral feeding initiated by 21 days of life
- Asymmetrical small-for-gestational age (SGA) infants and infants with patent ductus arteriosus (PDA) are eligible to participate
- Singleton or twin births only
Key exclusion criteria (7 listed)
- Serious congenital abnormalities that may affect growth and development
- Grade III or IV intraventricular hemorrhage (IVH)
- Maternal incapacity
- History of major surgery
- Extracorporeal membrane oxygenation (ECMO)
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 formulas and discharge formulasPreterm infant formulas to be consumed per health care provider orders | Other | Preterm formulas |
| Preterm infant formula with added soluble lipidsPreterm infant formula to be fed per healthcare provider instructions | Other | Infant Formula |
Primary outcome
The primary objective of this study is to compare the serum concentrations of fat soluble compounds in preterm infants fed a regimen of preterm formulas and in human milk fed infants
Time frame: variable
1 secondary outcome
Measures of eye function, ROP, measures of skin lipid soluble compound concentration
Time frame: variable
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 27 Apr 2009.
Related trials for Preterm Infants
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Effects of a Multisensory Intervention Program on the Term Behavior of the Very Premature Baby
Very Premature Baby
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The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants
Newborn Care, Pain Management
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Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates
Sepsis, PROM, Preterm (Pregnancy)
Not yet recruiting
The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
Preterm, Respiratory Distress Syndrome in Premature Infant
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Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
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.
Bridget Barrett-Reis, PhD study chair
Abbott Nutrition
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Preterm infant formulas and discharge formulas and Preterm infant formula with added soluble lipids in people with Preterm Infants, run by Abbott Nutrition at 8 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 6 inclusion and 7 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 27 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The primary objective of this study is to compare the serum concentrations of fat soluble compounds in preterm infants fed a regimen of preterm formulas and in human milk fed infants (time frame: variable). 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 27 Apr 2009.