VLBW - Very Low Birth Weight InfantNCT05744193
Feeding Study in VLBW Premature Infants
A study testing Exempt Infant Formula in people with VLBW - Very Low Birth Weight Infant, run by Mead Johnson Nutrition at 6 sites in United States.
Trial summary
A multi-center, single-blind, randomized, controlled, parallel-designed, prospective trial to compare growth between preterm infants fed one of three study human milk fortifiers added to human milk Read more about this study
- Who is it for?
- Ages 168 to 224 days
- Conditions the study is for
- VLBW - Very Low Birth Weight Infant
- What is being tested?
- Exempt Infant Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 6 sitesUnited States
- Study dates
- 10 Jul 2023to 31 May 2024
- 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 168 to 224 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinically and metabolically stable
- Birth weight 700 g to less than or equal to 1,250 g
- Appropriate birth weight for gestational age
- 24 0/7 to 32 0/7 weeks' gestational age at birth
- Exclusively fed human milk
- Signed informed consent and authorization to use and/or disclose PHI
Who cannot join
- Metabolic or chronic disease
- 5-minute Apgar score <4
- Major surgery
- Ventilator dependent
- Fluid restriction
- Grade III or IV intraventricular hemorrhage (IVH)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Augusta University
Augusta, Georgia, 30912
The University of Alabama at Birmingham
Birmingham, Alabama, 35233
Riley Children's Hospital
Indianapolis, Indiana, 46202
NYU Langone Hospital, Long Island
Mineola, New York, 11501
Cohen Children's Medical Center of NY
New Hyde Park, New York, 11040
Weill Cornell Medicine
New York, New York, 10021
About this study
Official title: Comparison of Multinutrient Human Milk Fortifiers in Preterm Infants: A Non-inferiority Single-blind, Randomized Controlled Trial (RCT)
A multi-center, single-blind, randomized, controlled, parallel-designed, prospective trial to compare growth between preterm infants fed one of three study human milk fortifiers added to human milk
- Conditions
- VLBW - Very Low Birth Weight Infant
- Being tested
- Exempt Infant Formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exempt Infant FormulaOther
Liquid human milk fortifier to be added to human milk daily
| Study group | Role | What they receive |
|---|---|---|
| Commercial Liquid Human Milk Fortifier | Active comparator | Liquid human milk fortifier to be added to human milk Receives: Other: Exempt Infant Formula |
| Liquid Human Milk Fortifier - Standard Protein | Experimental | Liquid human milk fortifier to be added to human milk Receives: Other: Exempt Infant Formula |
| Liquid Human Milk Fortifier - High Protein | Experimental | Liquid human milk fortifier to be added to human milk Receives: Other: Exempt Infant Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain
grams/kg/day
Measured: Daily for 28 days
Secondary outcomes (11)
Feeding Tolerance
Achievement of full enteral feeding, incidence of (TPN, Bloody stools, Feeding interruptions, Drop in feeding volume)
Measured: Daily for 28 days
Rate of Length and head circumference gain
cm/week
Measured: weekly up to day 28
Total energy intake
kcal
Measured: 28 days
Total protein intake
grams
Measured: 28 days
Respiratory status
Incidence of Apnea, Bradycardia, Supplemental oxygen/Continuous positive airway pressure/Nasal cannulation, Mechanical ventilation
Measured: 28 days
Incidence of NEC
Modified Bell's Staging Criteria
Measured: Study Day 0 through 28
Incidence of sepsis - clinical symptoms
Clinical symptoms - Changes in respiration, blood pressure, body temperature, stool, blood sugar and heart rate
Measured: Study Day 0 through 28
Incidence of sepsis - culture for pathogens
Culture for pathogens - no culture, culture-negative, culture-positive, presumed contaminant
Measured: Study day 0 through 28
Incidence of sepsis - Antibiotic use
Antibiotic use duration - less than 5 days ; 5 days or more
Measured: Study Day 0 through 28
Total serum CO2
less than 18 mmol/L
Measured: Study days 0, 14, 28
Metabolic Acidosis
If CO2 <18 mmol/L then Blood gas; Acidity (pH), Carbon dioxide, partial pressure (pCO2; torr), Bicarbonate (mmol/L); Base Excess (mmol/L)
Measured: Study days 0, 14, 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start10 Jul 2023
- Primary completion31 May 2024
- Study completion31 May 2024
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VLBW - Very Low Birth Weight InfantStudies 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744193
- Sponsor's protocol ID
- 3394-1
- Status last verified
- Jul 2024
- First submitted
- 31 Jan 2023
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Multinutrient Human Milk Fortifiers in Preterm Infants: A Non-inferiority Single-blind, Randomized Controlled Trial (RCT)
- ClinicalTrials.gov ID
- NCT05744193
- Acronym / sponsor ID
- 3394-1
- Conditions
- VLBW - Very Low Birth Weight Infant
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 24 Feb 2023 (actual)
- 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.
A multi-center, single-blind, randomized, controlled, parallel-designed, prospective trial to compare growth between preterm infants fed one of three study human milk fortifiers added to human milk
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Commercial Liquid Human Milk Fortifier | Active comparator | Other: Exempt Infant FormulaLiquid human milk fortifier to be added to human milk |
| Liquid Human Milk Fortifier - Standard Protein | Experimental | Other: Exempt Infant FormulaLiquid human milk fortifier to be added to human milk |
| Liquid Human Milk Fortifier - High Protein | Experimental | Other: Exempt Infant FormulaLiquid human milk fortifier to be added to human milk |
Who may qualify
- Ages
- 168 to 224 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Clinically and metabolically stable
- Birth weight 700 g to less than or equal to 1,250 g
- Appropriate birth weight for gestational age
- 24 0/7 to 32 0/7 weeks' gestational age at birth
- Exclusively fed human milk
Key exclusion criteria (6 listed)
- Metabolic or chronic disease
- 5-minute Apgar score <4
- Major surgery
- Ventilator dependent
- Fluid restriction
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 |
|---|---|---|
| Exempt Infant FormulaLiquid human milk fortifier to be added to human milk daily | Other | Commercial Liquid Human Milk Fortifier, Liquid Human Milk Fortifier - High Protein, Liquid Human Milk Fortifier - Standard Protein |
Primary outcome
Weight gain
Time frame: Daily for 28 days
grams/kg/day
11 secondary outcomes
Feeding Tolerance
Time frame: Daily for 28 days
Rate of Length and head circumference gain
Time frame: weekly up to day 28
Total energy intake
Time frame: 28 days
Total protein intake
Time frame: 28 days
Respiratory status
Time frame: 28 days
Incidence of NEC
Time frame: Study Day 0 through 28
Incidence of sepsis - clinical symptoms
Time frame: Study Day 0 through 28
Incidence of sepsis - culture for pathogens
Time frame: Study day 0 through 28
Incidence of sepsis - Antibiotic use
Time frame: Study Day 0 through 28
Total serum CO2
Time frame: Study days 0, 14, 28
Metabolic Acidosis
Time frame: Study days 0, 14, 28
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exempt Infant Formula in people with VLBW - Very Low Birth Weight Infant, run by Mead Johnson Nutrition at 6 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 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: stopped early, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 was stopped early (reason given: Slow recruitment). 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?
Weight gain (time frame: Daily for 28 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 9 Jul 2024.