PrematurityNCT01156493
Hydrolized Protein Formula for Premature Infants
A study testing Protein Hydrolyzed Premature Formula in people with Prematurity, run by University of Miami at 1 site in United States.
Trial summary
Premature infants fed with a protein hydrolyzed formula will have better tolerance needing shorter time to achieve full feeds when compared to those fed with an intact protein formula. Read more about this study
- Who is it for?
- Ages 3 days to 6 months
- Conditions the study is for
- Prematurity
- What is being tested?
- Protein Hydrolyzed Premature Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Sep 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 3 days to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birth weight between 500 -1500g and < 32 weeks GA who survive more than 3 days.
- Has not yet started enteral full feeds.
- Study explained and parent/caregiver demonstrating understanding of the given information.
- Informed consent signed.
Who cannot join
- Chromosomal anomalies.
- Major congenital anomalies (complex cardiac anomalies, congenital hydrocephalus, renal dysplasia).
- Congenital (e.g. jejunal atresia) and acquired (e.g. GI perforation) gastrointestinal pathology precluding oral feed and/or requiring major surgical or medical intervention.
- Parental refusal.
- Prior enrollment into a conflicting clinical trial. Conflicting clinical trial will be those in which the intervention could modify the outcome of the present study, for example studies aimed to accelerate feeds and or improve tolerance.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami/Holtz Children's Hospital/Neonatal Intensive Care Unit
Miami, Florida, 33136
About this study
Official title: Randomized Trial of Hydrolyzed Protein Premature Formula
Premature infants fed with a protein hydrolyzed formula will have better tolerance needing shorter time to achieve full feeds when compared to those fed with an intact protein formula.
Read the detailed description
The study formula is a 100% whey protein partially hydrolyzed (vs 60/40 Whey:Casein ratio of regular premature formulas) Because the tolerance and availability of breast milk is not predictable at the time of enrollment all the eligible premature infants will be randomized and assigned to the study or control group. Infants will receive formula, either because breast milk is not available or because indicated by the attending physician and switched to formula, They will be fed, depending of the group to what they are assigned, with either the PH formula for the study group or regular premature formula for the control group.
Randomization and blinding All eligible infants with parental consent will be randomized to either the study group to receive protein hydrolyzed formula (PH group) or to the control group to receive standard premature formula. Randomization will be stratified by 2 birth weight categories (500-1000 g and 1001-1500 g). The purpose of such stratification is to avoid imbalance between groups for factors that may influence outcome and is based on the different morbidity in different birth weight categories.
Masked randomization will be performed in a way that avoids the possibility of knowledge of treatment assignment at the time that eligibility is assessed and consent is sought. Only the person in charge of preparing the control or study formula will be aware of the infant's assignment group. Caregivers will remain masked to treatment group.
Study population Preterm newborns admitted to the neonatal intensive care unit with a birth weight 500-1500 g and who survive more than 3 days.
- Conditions
- Prematurity
- Being tested
- Protein Hydrolyzed Premature Formula
- Keywords
- feeding intolerance, prematurity
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein Hydrolyzed Premature FormulaOther
Infants will be fed with a protein hydrolyzed premature formula until they reach full feeds
| Study group | Role | What they receive |
|---|---|---|
| Protein Hydrolyzed Formula | Experimental | Infants assigned to this group will receive HP formula when breast milk not available or indicated to receive formula by the attending physician Receives: Other: Protein Hydrolyzed Premature Formula |
| Control | No intervention | Infants in this group will receive standard prematrue formula when no breast milk available or indicated by the attending physician |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to achieve full feeds
Number of days from initiating oral feeds to achieve full feeds
Measured: Average 1 to 3 weeks of life
Secondary outcomes (1)
Postnatal days to achieve full feeds
number of days from birth to achieve full feeds
Measured: Average: 1- 3 weeks of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionOct 2013
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Protein Hydrolized Formula
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teresa del Moral, University of Miami
- Investigators
- Teresa Del Moral, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01156493
- Sponsor's protocol ID
- 20090579
- Status last verified
- Nov 2015
- First submitted
- 1 Jul 2010
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Hydrolyzed Protein Premature Formula
- ClinicalTrials.gov ID
- NCT01156493
- Acronym / sponsor ID
- 20090579
- Conditions
- Prematurity
- Keywords
- feeding intolerance, prematurity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 2 Jul 2010 (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.
Premature infants fed with a protein hydrolyzed formula will have better tolerance needing shorter time to achieve full feeds when compared to those fed with an intact protein formula.
Detailed description
The study formula is a 100% whey protein partially hydrolyzed (vs 60/40 Whey:Casein ratio of regular premature formulas) Because the tolerance and availability of breast milk is not predictable at the time of enrollment all the eligible premature infants will be randomized and assigned to the study or control group. Infants will receive formula, either because breast milk is not available or because indicated by the attending physician and switched to formula, They will be fed, depending of the group to what they are assigned, with either the PH formula for the study group or regular premature formula for the control group.
Randomization and blinding All eligible infants with parental consent will be randomized to either the study group to receive protein hydrolyzed formula (PH group) or to the control group to receive standard premature formula. Randomization will be stratified by 2 birth weight categories (500-1000 g and 1001-1500 g). The purpose of such stratification is to avoid imbalance between groups for factors that may influence outcome and is based on the different morbidity in different birth weight categories.
Masked randomization will be performed in a way that avoids the possibility of knowledge of treatment assignment at the time that eligibility is assessed and consent is sought. Only the person in charge of preparing the control or study formula will be aware of the infant's assignment group. Caregivers will remain masked to treatment group.
Study population Preterm newborns admitted to the neonatal intensive care unit with a birth weight 500-1500 g and who survive more than 3 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Protein Hydrolized Formula
| Arm | Type | Receives |
|---|---|---|
| Protein Hydrolyzed Formula | Experimental | Other: Protein Hydrolyzed Premature FormulaInfants assigned to this group will receive HP formula when breast milk not available or indicated to receive formula by the attending physician |
| Control | No intervention | –Infants in this group will receive standard prematrue formula when no breast milk available or indicated by the attending physician |
Who may qualify
- Ages
- 3 days to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Birth weight between 500 -1500g and < 32 weeks GA who survive more than 3 days.
- Has not yet started enteral full feeds.
- Study explained and parent/caregiver demonstrating understanding of the given information.
- Informed consent signed.
Key exclusion criteria (5 listed)
- Chromosomal anomalies.
- Major congenital anomalies (complex cardiac anomalies, congenital hydrocephalus, renal dysplasia).
- Congenital (e.g. jejunal atresia) and acquired (e.g. GI perforation) gastrointestinal pathology precluding oral feed and/or requiring major surgical or medical intervention.
- Parental refusal.
- Prior enrollment into a conflicting clinical trial. Conflicting clinical trial will be those in which the intervention could modify the outcome of the present study, for example studies aimed to accelerate feeds and or improve tolerance.
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 |
|---|---|---|
| Protein Hydrolyzed Premature FormulaInfants will be fed with a protein hydrolyzed premature formula until they reach full feeds | Other | Protein Hydrolyzed Formula |
Primary outcome
Time to achieve full feeds
Time frame: Average 1 to 3 weeks of life
Number of days from initiating oral feeds to achieve full feeds
1 secondary outcome
Postnatal days to achieve full feeds
Time frame: Average: 1- 3 weeks of age
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 10 May 2017.
- Individual participant dataSharing planned: No
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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.
Teresa Del Moral, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein Hydrolyzed Premature Formula in people with Prematurity, run by University of Miami 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 4 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 10 May 2017. 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?
Time to achieve full feeds (time frame: Average 1 to 3 weeks of life). 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 10 May 2017.