Premature; Infant, Light-for-datesNCT02353013
Effect of Protein Intake on Preterm Infant Body Composition
A study testing Protein supplementation and Standard fortification in people with Premature; Infant, Light-for-dates, run by University of Oklahoma at 1 site in United States.
Trial summary
The investigators will compare weight gain based on fat accretion and change in body composition in preterm infants receiving different amounts of enteral protein. Read more about this study
- Who is it for?
- Ages 1 minute to 1 year
- Conditions the study is for
- Premature; Infant, Light-for-dates
- What is being tested?
- Protein supplementation and Standard fortification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to 1 Oct 2017
- 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 1 minute to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Premature infants born less than 32 weeks EGA
- Growth that is appropriate for gestational age (AGA)
- Admitted to OU Children's NICU, inborn or outborn
- Receiving enteral feedings <100 mL/kg/day
- Hemodynamically stable
Who cannot join
- Severe congenital anomalies to include congenital heart disease, chromosomal anomalies, open neural tube defects, and/or intestinal anomalies precluding enteral feedings
- Growth restriction, growth that is small for gestational age (SGA) or large for gestational age (LGA)
- Inborn errors of metabolism
- History of necrotizing enterocolitis Bell stage III
- Cerebrospinal fluid indwelling shunt (affects body composition measurements)
- Expected death prior to 36 weeks EGA (the end of the study period)
- Inability to meet Pea Pod® requirements for the first measurement
- On vasopressor medications
Trial locations and contacts
1 site in 1 country.
United States1 site
OUHSC Children's Hospital
Oklahoma City, Oklahoma, 73117
About this study
The investigators will compare weight gain based on fat accretion and change in body composition in preterm infants receiving different amounts of enteral protein.
Read the detailed description
American Academy of Pediatrics guidelines define the growth rate of preterm, underweight babies as adequate if it matches the age-equivalent weight gains typical of term infants, approximately 10-15 grams per kg per day. Unfortunately, many pre-terms, especially very low birth weight ones, do not achieve this rate, resulting in neurodevelopmental deficits and low discharge weights. Typical feeding regimens, designed to increase weight gain, however, have been shown to increase the rate of fat accretion and increase the risk of obesity and metabolic disorders, such as insulin resistance and type 2 diabetes, later in life. Research has shown that higher protein diets can reduce the accretion of body fat in older, normal weight infants but this has not been systematically tested in low birth weight pre-terms. The current study will compare weight gain based on fat accretion and change in body composition in preterm infants receiving higher (4g/100 kcal) versus lower (3 g/100 kcal) protein-energy ratio diets. The hypothesis tested in this study is: Increased protein intake will reduce the percentage of weight gain due to fat accretion in pre-term infants. The identification of an effective feeding regimen that would both allow pre-term infants to acquire age-equivalent growth rates similar to those of term infants while avoiding the excess accretion of body fat could significantly improve the long term health outcomes of this high-risk population.
- Conditions
- Premature; Infant, Light-for-dates
- Being tested
- Protein supplementation, Standard fortification
- Keywords
- protein intake, body composition
- 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 supplementationDietary supplement
Standard fortification of human milk may not have enough protein for optimal growth of premature infants. The investigators will add extra protein to this group to increase the protein consumed.
Standard fortificationDietary supplement
Standard fortification of human milk involves adding a commercially available human milk fortifier to human milk in order to increase several nutrients.
| Study group | Role | What they receive |
|---|---|---|
| Standard Protein Group | Active comparator | For infants in this group, the target protein-energy ratio (PER) will be ~3 g/100 kcal. This will be achieved by providing standard fortification by adding a commercially available human milk fortifier to human milk or by providing a preterm formula. Receives: Dietary Supplement: Standard fortification |
| Enhanced Protein Group | Experimental | For infants in this group, the target protein-energy ratio (PER) will be ~4 g/100 kcal. This will be achieved by providing standard fortification by adding a commercially available human milk fortifier to human milk or by providing a preterm formula. In addition, liquid protein will be added to provide protein supplementation and increase the PER. Receives: Dietary Supplement: Protein supplementation; Dietary Supplement: Standard fortification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain due to fat mass
Measured: 4 weeks
Secondary outcomes (4)
Change in body weight
Measured: 4 weeks
Change in percent fat mass
Measured: 4 weeks
Change in length
Measured: 4 weeks
Change in head circumference
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startDec 2014
- Primary completionJul 2017
- Study completion1 Oct 2017
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; Infant, Light-for-datesStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Courtney B. Atchley, DO, University of Oklahoma
- Investigators
- Courtney B Atchley, DO, Principal investigator, OUHSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02353013
- Sponsor's protocol ID
- 4885
- Status last verified
- Dec 2017
- First submitted
- 28 Jan 2015
- Last updated
- 22 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Atchley CB, Cloud A, Thompson D, Blunt MH, Satnes KJ, Szyld E, Ernst KD. Enhanced Protein Diet for Preterm Infants: A Prospective, Randomized, Double-blind, Controlled Trial. J Pediatr Gastroenterol Nutr. 2019 Aug;69(2):218-223. doi: 10.1097/MPG.0000000000002376.
PubMed 31058772
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Protein Intake on Preterm Infant Body Composition
- ClinicalTrials.gov ID
- NCT02353013
- Acronym / sponsor ID
- 4885
- Conditions
- Premature; Infant, Light-for-dates
- Keywords
- protein intake, body composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Jul 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 2 Feb 2015 (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 will compare weight gain based on fat accretion and change in body composition in preterm infants receiving different amounts of enteral protein.
Detailed description
American Academy of Pediatrics guidelines define the growth rate of preterm, underweight babies as adequate if it matches the age-equivalent weight gains typical of term infants, approximately 10-15 grams per kg per day. Unfortunately, many pre-terms, especially very low birth weight ones, do not achieve this rate, resulting in neurodevelopmental deficits and low discharge weights. Typical feeding regimens, designed to increase weight gain, however, have been shown to increase the rate of fat accretion and increase the risk of obesity and metabolic disorders, such as insulin resistance and type 2 diabetes, later in life. Research has shown that higher protein diets can reduce the accretion of body fat in older, normal weight infants but this has not been systematically tested in low birth weight pre-terms. The current study will compare weight gain based on fat accretion and change in body composition in preterm infants receiving higher (4g/100 kcal) versus lower (3 g/100 kcal) protein-energy ratio diets. The hypothesis tested in this study is: Increased protein intake will reduce the percentage of weight gain due to fat accretion in pre-term infants. The identification of an effective feeding regimen that would both allow pre-term infants to acquire age-equivalent growth rates similar to those of term infants while avoiding the excess accretion of body fat could significantly improve the long term health outcomes of this high-risk population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Protein Group | Active comparator | Dietary Supplement: Standard fortificationFor infants in this group, the target protein-energy ratio (PER) will be ~3 g/100 kcal. This will be achieved by providing standard fortification by adding a commercially available human milk fortifier to human milk or by providing a preterm formula. |
| Enhanced Protein Group | Experimental | Dietary Supplement: Protein supplementation, Dietary Supplement: Standard fortificationFor infants in this group, the target protein-energy ratio (PER) will be ~4 g/100 kcal. This will be achieved by providing standard fortification by adding a commercially available human milk fortifier to human milk or by providing a preterm formula. In addition, liquid protein will be added to provide protein supplementation and increase the PER. |
Who may qualify
- Ages
- 1 minute to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Premature infants born less than 32 weeks EGA
- Growth that is appropriate for gestational age (AGA)
- Admitted to OU Children's NICU, inborn or outborn
- Receiving enteral feedings <100 mL/kg/day
- Hemodynamically stable
Key exclusion criteria (8 listed)
- Severe congenital anomalies to include congenital heart disease, chromosomal anomalies, open neural tube defects, and/or intestinal anomalies precluding enteral feedings
- Growth restriction, growth that is small for gestational age (SGA) or large for gestational age (LGA)
- Inborn errors of metabolism
- History of necrotizing enterocolitis Bell stage III
- Cerebrospinal fluid indwelling shunt (affects body composition measurements)
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 supplementationStandard fortification of human milk may not have enough protein for optimal growth of premature infants. The investigators will add extra protein to this group to increase the protein consumed. | Dietary supplement | Enhanced Protein Group |
| Standard fortificationStandard fortification of human milk involves adding a commercially available human milk fortifier to human milk in order to increase several nutrients. | Dietary supplement | Enhanced Protein Group, Standard Protein Group |
Primary outcome
Weight gain due to fat mass
Time frame: 4 weeks
4 secondary outcomes
Change in body weight
Time frame: 4 weeks
Change in percent fat mass
Time frame: 4 weeks
Change in length
Time frame: 4 weeks
Change in head circumference
Time frame: 4 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 22 Dec 2017.
- Derived from this study: PubMed 31058772Atchley CB, Cloud A, Thompson D, Blunt MH, Satnes KJ, Szyld E, Ernst KD. Enhanced Protein Diet for Preterm Infants: A Prospective, Randomized, Double-blind, Controlled Trial. J Pediatr Gastroenterol Nutr. 2019 Aug;69(2):218-223. doi: 10.1097/MPG.0000000000002376.
- Individual participant dataSharing planned: No
Related trials for Premature; Infant, Light-for-dates
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
Active, not recruiting
Early Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants
Prematurity, Light-For-Dates
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.
Courtney B Atchley, DO principal investigator
OUHSC
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 supplementation and Standard fortification in people with Premature; Infant, Light-for-dates, run by University of Oklahoma 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 5 inclusion and 8 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 22 Dec 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?
Weight gain due to fat mass (time frame: 4 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 NCT02353013, 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 22 Dec 2017.