Growth in Premature InfantsPhase 2NCT01991613
Early Protein Supplementation of Human Milk in Extremely Low Birth Weight Infants
A Phase 2 study testing liquid protein supplement in people with Growth in Premature Infants, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
We hypothesize that premature infants who receive their mothers' expressed breast milk supplemented with liquid protein early in their hospitalization will have a growth velocity in the first 28 days of life that is 20% greater than the growth velocity of premature infants that do not receive protein fortification. Read more about this study
- Who is it for?
- Ages 26 to 33 weeks
- Conditions the study is for
- Growth in Premature Infants
- What is being tested?
- liquid protein supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Jun 2015
- Phase
- Phase 2
- 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 26 to 33 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- inborn at Mount Sinai Medical Center
- gestational age between 26 0/7 weeks and 32 6/7 weeks gestation
- plan by family for their infant to receive human milk feeds
Who cannot join
- outborn infants
- gestational age < 26 0/7 weeks or > 33 0/7 weeks
- major congenital anomalies including cardiac disease, inborn errors of metabolism etc.
- sepsis and/or other serious clinical complication precluding initiation of enteral feeds
- plan by family for their infant to receive primarily preterm infant formula.
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Early Liquid Protein Supplementation of Human Milk in Extremely Low Birth Weight Infants
We hypothesize that premature infants who receive their mothers' expressed breast milk supplemented with liquid protein early in their hospitalization will have a growth velocity in the first 28 days of life that is 20% greater than the growth velocity of premature infants that do not receive protein fortification.
- Conditions
- Growth in Premature Infants
- Being tested
- liquid protein supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liquid protein supplementDietary supplement
Also called Abbott liquid protein supplement
The liquid protein supplement is already in use. The purpose of this study is to determine whether using the supplement earlier will lead to improved growth.
| Study group | Role | What they receive |
|---|---|---|
| liquid protein supplement | Experimental | Study subjects will receive standard of care nutrition with the addition of a liquid protein supplement when the baby is able to tolerate an enteral feeding volume of 40mL/kg/day. Receives: Dietary Supplement: liquid protein supplement |
| Control group | No intervention | Study subjects will receive standard of care nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth velocity
Growth velocity over the first 28 days of life - Daily weight measurements for the first 28 days of life
Measured: up to 28 days
Secondary outcomes (3)
weight
Extrauterine growth from birth until discharge from the NICU - Weekly weight measurements until discharge from the NICU
Measured: average 11 weeks
Length
Extrauterine growth from birth until discharge from the NICU - Weekly length measurements until discharge from the NICU
Measured: average 11 weeks
head circumference
Extrauterine growth from birth until discharge from the NICU - Weekly head circumference measurements until discharge from the NICU
Measured: average 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth in Premature InfantsStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Weintraub, Icahn School of Medicine at Mount Sinai
- Investigators
- Andrea Weintraub, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01991613
- Sponsor's protocol ID
- GCO 13-1422
- Status last verified
- Sep 2015
- First submitted
- 18 Nov 2013
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Liquid Protein Supplementation of Human Milk in Extremely Low Birth Weight Infants
- ClinicalTrials.gov ID
- NCT01991613
- Acronym / sponsor ID
- GCO 13-1422
- Conditions
- Growth in Premature Infants
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 25 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.
We hypothesize that premature infants who receive their mothers' expressed breast milk supplemented with liquid protein early in their hospitalization will have a growth velocity in the first 28 days of life that is 20% greater than the growth velocity of premature infants that do not receive protein fortification.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| liquid protein supplement | Experimental | Dietary Supplement: liquid protein supplementStudy subjects will receive standard of care nutrition with the addition of a liquid protein supplement when the baby is able to tolerate an enteral feeding volume of 40mL/kg/day. |
| Control group | No intervention | –Study subjects will receive standard of care nutrition |
Who may qualify
- Ages
- 26 to 33 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- inborn at Mount Sinai Medical Center
- gestational age between 26 0/7 weeks and 32 6/7 weeks gestation
- plan by family for their infant to receive human milk feeds
Key exclusion criteria (5 listed)
- outborn infants
- gestational age < 26 0/7 weeks or > 33 0/7 weeks
- major congenital anomalies including cardiac disease, inborn errors of metabolism etc.
- sepsis and/or other serious clinical complication precluding initiation of enteral feeds
- plan by family for their infant to receive primarily preterm infant formula.
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 |
|---|---|---|
| liquid protein supplementAlso: Abbott liquid protein supplementThe liquid protein supplement is already in use. The purpose of this study is to determine whether using the supplement earlier will lead to improved growth. | Dietary supplement | liquid protein supplement |
Primary outcome
Growth velocity
Time frame: up to 28 days
Growth velocity over the first 28 days of life - Daily weight measurements for the first 28 days of life
3 secondary outcomes
weight
Time frame: average 11 weeks
Length
Time frame: average 11 weeks
head circumference
Time frame: average 11 weeks
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 23 Sep 2015.
Related trials for Growth in Premature Infants
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Serial Brain MRI in Hospitalized Preterm Infants
Preterm Birth Complication
Active, not recruiting
Early DHA/ARA Supplementation in Growth-restricted Very Preterm Infants: A Randomized Clinical Trial
Infant Malnutrition, Light-For-Dates With Signs of Fetal Malnutrition
Not yet recruitingObservational study
eCPAP Follow-up at School Age
Lung Function
Active, not recruiting
Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk
Prematurity; Extreme, Feeding Disorder Neonatal
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.
Andrea Weintraub, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing liquid protein supplement in people with Growth in Premature Infants, run by Icahn School of Medicine at Mount Sinai 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 3 inclusion and 5 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 23 Sep 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.
What does this 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.
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?
Growth velocity (time frame: up to 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 23 Sep 2015.