Premature; InfantNCT01988792
Human Milk Fortification in Very Low Birth Neonates
A study testing Human milk fortifiers in people with Premature; Infant and Enteral Nutrition, run by University of Tennessee at 1 site in United States.
Trial summary
The purpose of this study to find out how safely we can add extra nutrients to human milk at different feeding volume. Read more about this study
- Who is it for?
- Ages 2 to 7 days
- Conditions the study is for
- Premature; Infant, Enteral Nutrition, Human Milk
- What is being tested?
- Human milk fortifiers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Apr 2015
- 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 2 to 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Very low birth weight infants who receive human milk (mother's milk or banked donor human milk).
Who cannot join
- Major congenital anomalies such as cardiac defect, neural tube defect, chromosomal abnormality and gastrointestinal defect.
- Died or extended to die within 48 hours of life
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Tennessee, Health Science Center, The Regional Medical Center
Memphis, Tennessee, 38163
About this study
Official title: Human Milk Fortification and Feeding Intolerance in Very Low Birth Weight Neonates
The purpose of this study to find out how safely we can add extra nutrients to human milk at different feeding volume.
Read the detailed description
Very low birth weight babies (weight less than three pounds and three ounces) are extremely fragile and lacking important nutrition due to premature birth. They need enough calories for catch-up growth. Giving adequate nutrition is very important for their growth and development. Human milk is the best food, however it is not enough to provide all the required calories and nutrients for catch up growth and maintain adequate strength of the bones (bone mineralization). For premature babies, extra nutrients (human milk fortifier) are usually added to the human milk to provide adequate nutrition. These extra nutrients will be derived from cow's milk. Currently, a practice of fortifying human milk varies. There is no clear information when to start adding extra nutrients to human milk.
- Conditions
- Premature; Infant, Enteral Nutrition, Human Milk, Fortification
- Being tested
- Human milk fortifiers
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human milk fortifiersDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Fortification at 20 ml/kg/day feeding volume | Active comparator | Human milk fortifiers will be added to the human milk when neonates reach to feeding volume of 20 ml/kg/day. Receives: Dietary Supplement: Human milk fortifiers |
| Fortification at 100 ml/kg/day feeding volume | Active comparator | human milk fortifiers will be added to the human milk when neonates reach to feeding volume of 100 ml/kg/day. Receives: Dietary Supplement: Human milk fortifiers |
What is being measured
The primary outcome is the main question the study is designed to answer.
The days to reach full enteral feeding volume (140 ml/kg/day).
Measured: 4 - 6 weeks
Secondary outcomes (7)
Neonatal Outcomes
Necrotizing Enterocolitis
Measured: until 36 weeks PMA
Neonatal Outcomes
Chronic Lung Disease
Measured: until 36 weeks PMA
Neonatal Outcomes
Feeding intolerance
Measured: Until full feeding volume
Neonatal Outcomes
Parental nutrition days
Measured: Until full feeding volume
Neonatal Outcomes
Ventilator days
Measured: until 36 weeks PMA
Neonatal Outcomes
Protein and caloric intake
Measured: until 4 weeks of life
Neonatal Outcomes
Growth anthropometry
Measured: until 4 weeks of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature; 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanket D Shah, MBBS, Principal investigator, UTHSC, Memphis, TNAjay J Talati, MD, Principal investigator, UTHSC, Memphis, TN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01988792
- Sponsor's protocol ID
- 13-02741-FB
- Other IDs
- 8671-2075
- Status last verified
- Jul 2015
- First submitted
- 12 Nov 2013
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shah SD, Dereddy N, Jones TL, Dhanireddy R, Talati AJ. Early versus Delayed Human Milk Fortification in Very Low Birth Weight Infants-A Randomized Controlled Trial. J Pediatr. 2016 Jul;174:126-131.e1. doi: 10.1016/j.jpeds.2016.03.056. Epub 2016 Apr 23.
PubMed 27112041
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Milk Fortification and Feeding Intolerance in Very Low Birth Weight Neonates
- ClinicalTrials.gov ID
- NCT01988792
- Acronym / sponsor ID
- 13-02741-FB
- Conditions
- Premature; Infant, Enteral Nutrition, Human Milk, Fortification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 20 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.
The purpose of this study to find out how safely we can add extra nutrients to human milk at different feeding volume.
Detailed description
Very low birth weight babies (weight less than three pounds and three ounces) are extremely fragile and lacking important nutrition due to premature birth. They need enough calories for catch-up growth. Giving adequate nutrition is very important for their growth and development. Human milk is the best food, however it is not enough to provide all the required calories and nutrients for catch up growth and maintain adequate strength of the bones (bone mineralization). For premature babies, extra nutrients (human milk fortifier) are usually added to the human milk to provide adequate nutrition. These extra nutrients will be derived from cow's milk. Currently, a practice of fortifying human milk varies. There is no clear information when to start adding extra nutrients to human milk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fortification at 20 ml/kg/day feeding volume | Active comparator | Dietary Supplement: Human milk fortifiersHuman milk fortifiers will be added to the human milk when neonates reach to feeding volume of 20 ml/kg/day. |
| Fortification at 100 ml/kg/day feeding volume | Active comparator | Dietary Supplement: Human milk fortifiershuman milk fortifiers will be added to the human milk when neonates reach to feeding volume of 100 ml/kg/day. |
Who may qualify
- Ages
- 2 to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Very low birth weight infants who receive human milk (mother's milk or banked donor human milk).
Key exclusion criteria (2 listed)
- Major congenital anomalies such as cardiac defect, neural tube defect, chromosomal abnormality and gastrointestinal defect.
- Died or extended to die within 48 hours of life
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 |
|---|---|---|
| Human milk fortifiers | Dietary supplement | Fortification at 100 ml/kg/day feeding volume, Fortification at 20 ml/kg/day feeding volume |
Primary outcome
The days to reach full enteral feeding volume (140 ml/kg/day).
Time frame: 4 - 6 weeks
7 secondary outcomes
Neonatal Outcomes
Time frame: until 36 weeks PMA
Neonatal Outcomes
Time frame: until 36 weeks PMA
Neonatal Outcomes
Time frame: Until full feeding volume
Neonatal Outcomes
Time frame: Until full feeding volume
Neonatal Outcomes
Time frame: until 36 weeks PMA
Neonatal Outcomes
Time frame: until 4 weeks of life
Neonatal Outcomes
Time frame: until 4 weeks of life
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 29 Jul 2015.
- Derived from this study: PubMed 27112041Shah SD, Dereddy N, Jones TL, Dhanireddy R, Talati AJ. Early versus Delayed Human Milk Fortification in Very Low Birth Weight Infants-A Randomized Controlled Trial. J Pediatr. 2016 Jul;174:126-131.e1. doi: 10.1016/j.jpeds.2016.03.056. Epub 2016 Apr 23.
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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.
Sanket D Shah, MBBS principal investigator
UTHSC, Memphis, TN
Ajay J Talati, MD principal investigator
UTHSC, Memphis, TN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human milk fortifiers in people with Premature; Infant and Enteral Nutrition, run by University of Tennessee at 1 site 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 1 inclusion and 2 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 29 Jul 2015. 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 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?
The days to reach full enteral feeding volume (140 ml/kg/day). (time frame: 4 - 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01988792, which also lists 1 linked publication.
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 29 Jul 2015.