Pre-term InfantsPhase 2/3NCT01766011
Evaluation of a Standard Preterm Infant Formula Fed to Preterm Infants in the Hospital
A Phase 2/3 study testing study pre-term formula in people with Pre-term Infants, run by Abbott Nutrition at 7 sites in United States.
Trial summary
The purpose of this study is to assess overall growth of preterm infants fed a reformulated preterm infant formula during hospitalization. All study products meet levels of nutrients for the infant population as specified in the Infant Formula Act and all subsequent amendments. Read more about this study
- Who is it for?
- Ages Up to 21 days
- Conditions the study is for
- Pre-term Infants
- What is being tested?
- study pre-term formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 7 sitesUnited States
- Study dates
- Nov 2012to Oct 2013
- Phase
- Phase 2/3
- 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
- Subjects eligible for study participation will satisfy the following criteria:
- Birth weight between 1000g -1800g
- Less than or equal to 34 weeks and 0 days gestational age at birth
- Appropriate for gestational age (AGA)
- Singleton or twin births
- Infant is 21 days of age or less
Who cannot join
- Infants with the following conditions prior to and/or at the time of study product initiation are not eligible for entry into the study:
- Expected to be transferred to another facility within 14 days
- Serious congenital abnormalities that may affect growth and development
- Intubated for ventilation at the time of study product initiation
- Grade III or IV periventricular/intraventricular hemorrhage (PVH/IVH)
- Maternal incapacity, maternal drug or alcohol abuse during pregnancy or current abuse, or maternal treatment consistent with human immunodeficiency virus therapy
Show all 11Show fewer
- Infant has a history of major surgery
- Asphyxia defined as progressive hypoxemia and hypercapnia with significant metabolic acidemia
- Confirmed necrotizing enterocolitis or confirmed sepsis
- Current use or planned use of probiotics
- Participation in another study that has not been approved
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
MetroHealth Medical Center
Cleveland, Ohio, 44109
Wheaton Franciscan Healthcare-St. Joseph
Milwaukee, Wisconsin, 53210
University of South Alabama - Children's and Women's Hospital
Mobile, Alabama, 36604
Memorial Hospital of South Bend
South Bend, Indiana, 46601
Maria Children's Hospital Westchester Medical Center
Valhalla, New York, 10595
Wesley Medical Center
Wichita, Kansas, 67214
About this study
The purpose of this study is to assess overall growth of preterm infants fed a reformulated preterm infant formula during hospitalization. All study products meet levels of nutrients for the infant population as specified in the Infant Formula Act and all subsequent amendments.
- Conditions
- Pre-term Infants
- Being tested
- study pre-term formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
study pre-term formulaOther
Also called Similac Special Care
24 kcal/fl oz pre-term formula for in-hospital use
| Study group | Role | What they receive |
|---|---|---|
| study pre-term formula | Experimental | Pre-term formula with a modified stabilizer system in 2 oz. ready to feed plastic bottles Receives: Other: study pre-term formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain per day
weight gain per day (g/kg/d)
Measured: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first
Secondary outcomes (8)
Length
Growth, change in length
Measured: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first
Daily Stool Questionnaire
Gastro-intestinal Tolerance; Presence of bloody, watery, hard or black stools will be captured.
Measured: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first
Serum Calcium
Blood biochemistries
Measured: SDAY 1, 15, and 29 or hospital discharge (whichever comes first)
Head circumference
Growth, change in head circumference
Measured: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first
Daily Feeding Questionnaire
Gastro-Intestinal Tolerance; Cause for withholding feedings will be captured.
Measured: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first
Any periods of nil per os (NPO)
Gastro-Intestinal Tolerance
Measured: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first
Phosphorus
Blood biochemistries
Measured: SDAY 1, 15, and 29 or hospital discharge (whichever comes first)
Alkaline Phosphatase
Blood biochemistries
Measured: SDAY 1, 15, and 29 or hospital discharge (whichever comes first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study startNov 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-term 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 2/3
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bridget Barrett Reis, PhD, RD, LD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01766011
- Sponsor's protocol ID
- AL01
- Status last verified
- Mar 2015
- First submitted
- 8 Jan 2013
- Last updated
- 3 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Standard Preterm Infant Formula Fed to Preterm Infants in the Hospital
- ClinicalTrials.gov ID
- NCT01766011
- Acronym / sponsor ID
- AL01
- Conditions
- Pre-term Infants
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 11 Jan 2013 (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 overall growth of preterm infants fed a reformulated preterm infant formula during hospitalization. All study products meet levels of nutrients for the infant population as specified in the Infant Formula Act and all subsequent amendments.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study pre-term formula | Experimental | Other: study pre-term formulaPre-term formula with a modified stabilizer system in 2 oz. ready to feed plastic bottles |
Who may qualify
- Ages
- Up to 21 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Subjects eligible for study participation will satisfy the following criteria:
Key exclusion criteria (11 listed)
- Infants with the following conditions prior to and/or at the time of study product initiation are not eligible for entry into the study:
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 |
|---|---|---|
| study pre-term formulaAlso: Similac Special Care24 kcal/fl oz pre-term formula for in-hospital use | Other | study pre-term formula |
Primary outcome
Weight gain per day
Time frame: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first
weight gain per day (g/kg/d)
8 secondary outcomes
Length
Time frame: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first
Daily Stool Questionnaire
Time frame: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first
Serum Calcium
Time frame: SDAY 1, 15, and 29 or hospital discharge (whichever comes first)
Head circumference
Time frame: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first
Daily Feeding Questionnaire
Time frame: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first
Any periods of nil per os (NPO)
Time frame: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first
Phosphorus
Time frame: SDAY 1, 15, and 29 or hospital discharge (whichever comes first)
Alkaline Phosphatase
Time frame: SDAY 1, 15, and 29 or hospital discharge (whichever comes first)
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 3 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.
Bridget Barrett Reis, PhD, RD, LD study chair
Abbott Nutrition
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing study pre-term formula in people with Pre-term Infants, run by Abbott Nutrition at 7 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 11 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 3 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 7 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Weight gain per day (time frame: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first). 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 3 Mar 2015.