Problem With Growth of an InfantNCT01609868
The Effect of a Liquid Protein Modular on Growth and Outcomes in the NICU
A study testing Powder protein modular and Liquid protein modular in people with Problem With Growth of an Infant, run by University of Nebraska at 1 site in United States.
Trial summary
The investigators hypothesis that premature infants receiving a commercially available liquid protein modular will have improved growth when compared with premature infants receiving a commercially available powder protein modular. Read more about this study
- Who is it for?
- Ages Up to 40 weeks
- Conditions the study is for
- Problem With Growth of an Infant
- What is being tested?
- Powder protein modular and Liquid protein modular
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Jun 2013
- 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 Up to 40 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants less than 2000 gms at birth, receiving maternal breast milk
Who cannot join
- Infants receiving formula
Trial locations and contacts
1 site in 1 country.
About this study
The investigators hypothesis that premature infants receiving a commercially available liquid protein modular will have improved growth when compared with premature infants receiving a commercially available powder protein modular.
- Conditions
- Problem With Growth of an Infant
- Being tested
- Powder protein modular, Liquid protein modular
- Keywords
- premature infant feeding protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Powder protein modularDietary supplement
Infants will receive powder protein modular to achieve 4 grm/kg/day
Liquid protein modularDietary supplement
Infants will receive a commerically avaliable liquid protein modular to provide 4 grm/kg/day
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | infants in this arm will receive the current treatment that is standard of care for these infants, powder protein modular to achieve 4 gm/kg/day Receives: Dietary Supplement: Powder protein modular |
| experimental | Experimental | this group will receive a liquid protein modular that recently became commercially avaliable, to achieve the same protein of 4 grm/kg/day as the powder comparision group Receives: Dietary Supplement: Liquid protein modular |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth in premature infants (percentile ranking at 36 weeks CGA)
Measured: birth to 36 weeks
Secondary outcomes (1)
GI tolerance
abdominal distention, feeding tolerance
Measured: birth to 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Problem With Growth of an InfantStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- Alegent Health Bergan Mercy Medical Center
- Responsible party
- Principal investigator, Corrine K. Hanson, PhD, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01609868
- Sponsor's protocol ID
- 12-16432
- Status last verified
- Jan 2018
- First submitted
- 30 May 2012
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Liquid Protein Modular on Growth and Outcomes in the NICU
- ClinicalTrials.gov ID
- NCT01609868
- Acronym / sponsor ID
- 12-16432
- Conditions
- Problem With Growth of an Infant
- Keywords
- premature infant feeding protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- Alegent Health Bergan Mercy Medical Center
- Study start
- Jun 2012 (actual)
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 1 Jun 2012 (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 investigators hypothesis that premature infants receiving a commercially available liquid protein modular will have improved growth when compared with premature infants receiving a commercially available powder protein modular.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Dietary Supplement: Powder protein modularinfants in this arm will receive the current treatment that is standard of care for these infants, powder protein modular to achieve 4 gm/kg/day |
| experimental | Experimental | Dietary Supplement: Liquid protein modularthis group will receive a liquid protein modular that recently became commercially avaliable, to achieve the same protein of 4 grm/kg/day as the powder comparision group |
Who may qualify
- Ages
- Up to 40 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants less than 2000 gms at birth, receiving maternal breast milk
Key exclusion criteria (1 listed)
- Infants receiving 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 |
|---|---|---|
| Powder protein modularInfants will receive powder protein modular to achieve 4 grm/kg/day | Dietary supplement | control |
| Liquid protein modularInfants will receive a commerically avaliable liquid protein modular to provide 4 grm/kg/day | Dietary supplement | experimental |
Primary outcome
Growth in premature infants (percentile ranking at 36 weeks CGA)
Time frame: birth to 36 weeks
1 secondary outcome
GI tolerance
Time frame: birth to 36 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 31 Jan 2018.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Powder protein modular and Liquid protein modular in people with Problem With Growth of an Infant, run by University of Nebraska 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 1 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 31 Jan 2018. 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?
Growth in premature infants (percentile ranking at 36 weeks CGA) (time frame: birth to 36 weeks). 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 31 Jan 2018.