Feeding IntoleranceNCT01987154
Tolerance of an Extensively Hydrolyzed Protein Infant Formula Versus a Premature Infant Formula
A study testing Marketed cow milk-based premature infant formula and Marketed extensively hydrolyzed casein infant formula in people with Feeding Intolerance, run by Mead Johnson Nutrition at 1 site in Italy.
Trial summary
To evaluate the use of a hypoallergenic infant formula containing an extensively hydrolyzed protein source for routine nutrition. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Feeding Intolerance
- What is being tested?
- Marketed cow milk-based premature infant formula and Marketed extensively hydrolyzed casein infant formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2014to Mar 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Premature infant 28 to 33 weeks gestational age, inclusive, at birth
- Infant has never received enteral feedings or current enteral intake is less than 30 mL/kg/day
- Birth weight is greater than or equal to 700g to 1750g
- Appropriate birth weight for gestational age
- Singleton or twin birth
- Signed Informed consent
Who cannot join
- Infant's mother plans to exclusively breast feed
- 5 minute APGAR score is less than or equal to 4
- Major surgery that required general anesthesia prior to randomization
- Ventilator-dependent or requiring greater than 40% FiO2 on day of randomization
- Grade III or IV intraventricular hemorrhage diagnosed prior to randomization
- Infant is currently participating in another clinical study
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda Ospedaliera "Ospedale Policlinico Consorziale" di Bari
Bari, Apulia, 70124
About this study
To evaluate the use of a hypoallergenic infant formula containing an extensively hydrolyzed protein source for routine nutrition.
- Conditions
- Feeding Intolerance
- Being tested
- Marketed cow milk-based premature infant formula, Marketed extensively hydrolyzed casein infant formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marketed cow milk-based premature infant formulaOther
Marketed extensively hydrolyzed casein infant formulaOther
| Study group | Role | What they receive |
|---|---|---|
| Marketed cow milk-based premature infant formula | Active comparator | Not described Receives: Other: Marketed cow milk-based premature infant formula |
| Marketed extensively hydrolyzed casein infant formula | Experimental | Not described Receives: Other: Marketed extensively hydrolyzed casein infant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enteral intake (ml/kg/day)
Measured: Daily for 14 days
Secondary outcomes (7)
Body Weight (g)
Measured: Daily for 14 days
Feeding Tolerance
Gastric residuals, regurgitation(>1 ml), fecal output (number of stools per day)
Measured: Daily for 14 days
Respiratory status
Apnea and/or bradycardia events, use of supplemental oxygen, use of mechanical ventilation
Measured: Daily for 14 days
Gut Inflammation
Fecal calprotectin, alpha and beta defensins, TNF alpha, gastric ultrasound
Measured: Once at Study Day 14
Confirmed or suspected sepsis or necrotizing enterocolitis
Measured: Daily for 14 days
Date of hospital discharge
Measured: Once at hospital discharge
Growth
length (cm) and head circumference (cm)
Measured: Study Days 1, 7, and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2013 (estimated)
- Study startFeb 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding IntoleranceStudies 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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mariella Baldassarre, M.D., Principal investigator, Universita degli Studi di Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01987154
- Sponsor's protocol ID
- 6020
- Status last verified
- May 2016
- First submitted
- 5 Nov 2013
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance of an Extensively Hydrolyzed Protein Infant Formula Versus a Premature Infant Formula
- ClinicalTrials.gov ID
- NCT01987154
- Acronym / sponsor ID
- 6020
- Conditions
- Feeding Intolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 19 Nov 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.
To evaluate the use of a hypoallergenic infant formula containing an extensively hydrolyzed protein source for routine nutrition.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Marketed cow milk-based premature infant formula | Active comparator | Other: Marketed cow milk-based premature infant formula |
| Marketed extensively hydrolyzed casein infant formula | Experimental | Other: Marketed extensively hydrolyzed casein infant formula |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Premature infant 28 to 33 weeks gestational age, inclusive, at birth
- Infant has never received enteral feedings or current enteral intake is less than 30 mL/kg/day
- Birth weight is greater than or equal to 700g to 1750g
- Appropriate birth weight for gestational age
- Singleton or twin birth
Key exclusion criteria (6 listed)
- Infant's mother plans to exclusively breast feed
- 5 minute APGAR score is less than or equal to 4
- Major surgery that required general anesthesia prior to randomization
- Ventilator-dependent or requiring greater than 40% FiO2 on day of randomization
- Grade III or IV intraventricular hemorrhage diagnosed prior to randomization
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 |
|---|---|---|
| Marketed cow milk-based premature infant formula | Other | Marketed cow milk-based premature infant formula |
| Marketed extensively hydrolyzed casein infant formula | Other | Marketed extensively hydrolyzed casein infant formula |
Primary outcome
Enteral intake (ml/kg/day)
Time frame: Daily for 14 days
7 secondary outcomes
Body Weight (g)
Time frame: Daily for 14 days
Feeding Tolerance
Time frame: Daily for 14 days
Respiratory status
Time frame: Daily for 14 days
Gut Inflammation
Time frame: Once at Study Day 14
Confirmed or suspected sepsis or necrotizing enterocolitis
Time frame: Daily for 14 days
Date of hospital discharge
Time frame: Once at hospital discharge
Growth
Time frame: Study Days 1, 7, and 14
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 17 May 2016.
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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.
Mariella Baldassarre, M.D. principal investigator
Universita degli Studi di Bari
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Marketed cow milk-based premature infant formula and Marketed extensively hydrolyzed casein infant formula in people with Feeding Intolerance, run by Mead Johnson Nutrition at 1 site in Italy.
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 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 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Enteral intake (ml/kg/day) (time frame: Daily for 14 days). 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 17 May 2016.