Preterm InfantNCT03306316
Prebiotic in Preterm Infants
A study testing Prebiotic in people with Preterm Infant and Development, Infant, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
This is a double blinded, randomized, controlled trial of prebiotic in infants born between 26 and 32 weeks gestational age. The investigators anticipate enrollment of 90 subjects in total and for the study to be completed in 18 months. Read more about this study
- Who is it for?
- Ages 7 to 10 days
- Conditions the study is for
- Preterm Infant, Development, Infant, Nutrition
- What is being tested?
- Prebiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jul 2018to 31 Dec 2023
- 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 7 to 10 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants who meet the following inclusion criteria will be eligible for randomization:
- Subjects will be preterm infants born 700 and 1800 g birthweight (inclusive), and >/=26 weeks to 31 6/7 weeks.
- Subject's parent(s) or legal guardian(s) have voluntarily signed and dated an informed consent form (ICF). They have also provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.
- Signed consent is obtained by day 10 after birth.
- Mother plans to provide her own milk or consents to use of donor human milk in NICU.
Who cannot join
- Infants with the following conditions or situations at the time of randomization will be excluded from the study:
- Subject has known congenital anomalies.
- Administration of enteral clinical product must be initiated by 9 ± 2 days of life (birth date is day of life 0).
- Confirmed necrotizing enterocolitis (Bell's Stage II or III, Appendix J) or confirmed sepsis (positive culture requiring antibiotic treatment).
- Steroid use at time of randomization
- Mechanical ventilator dependence.
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- >2 days of antimicrobial use prior to enrollment
- Maternal incapacity: including maternal opioids, cocaine or alcohol abuse during pregnancy or current
- Mother or infant is currently receiving treatment consistent with HIV therapy.
- Mother plans to formula feed exclusively and has not consented to use of donor milk during NICU stay.
- Infant with intraventricular hemorrhage
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital and affiliated NICUs
Columbus, Ohio, 43206
About this study
Official title: The Impact of Prebiotic on Growth, Feeding Progression and Neurodevelopment in Preterm Infants
This is a double blinded, randomized, controlled trial of prebiotic in infants born between 26 and 32 weeks gestational age. The investigators anticipate enrollment of 90 subjects in total and for the study to be completed in 18 months. The investigators anticipate collecting clinical data, anthropometrics, stool samples (requiring appropriate storage through analysis), salivary samples from mother and infant, discarded blood samples from baby after the standard care lab tests are done, a single, optional blood draw at the conclusion of the study, and subjecting infants to a neurodevelopmental survey at study completion.
The overall goal of this study is to test prebiotic administration to human milk-fed infants who are 700 gram to 1800 gram birthweight. The goal of this study will be addressed through one primary aim, a secondary aim, and exploratory aims, indicated below:
Read more
Primary aim: Compare weight, length, and head circumference Z-score growth between the study and placebo groups.
Secondary aim: Compare the time taken to achieve full feedings (135 mL/kg/day or more) between the study and placebo groups.
Exploratory aim 1: Compare neurobehavior, as measured by the validated Neonatal intensive care unit Network Neurobehavioral Scale (NNNS), between the study and placebo groups.
Exploratory aim 2: Compare fecal calprotectin levels to determine the impact of supplementation on reducing intestinal inflammation between the study and placebo groups.
Exploratory aim 3: Compare fecal microbiome between the prebiotic and placebo groups, to determine whether there is a shift in microbial composition towards bifidobacteria and other microbes that are capable of metabolizing prebiotic.
- Conditions
- Preterm Infant, Development, Infant, Nutrition
- Being tested
- Prebiotic, Dextrose Control
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrebioticDietary supplement
Also called Study product
Prebiotic experimental group
Dextrose ControlDietary supplement
Dextrose Control
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Experimental Arm Receives: Dietary Supplement: Prebiotic |
| Control | Placebo comparator | Placebo Control Arm Receives: Dietary Supplement: Dextrose Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Compare weight
Measured: Enrollment through study day 45
Length
Compare length
Measured: Enrollment through study day 45
Head Circumference
Compare head circumference
Measured: Enrollment through study day 45
Secondary outcomes (1)
Adaptation
Compare time to enteral autonomy
Measured: Enrollment through study day 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start4 Jul 2018
- Primary completion1 Jul 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ethan Mezoff, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306316
- Sponsor's protocol ID
- ColumbusCRI
- Status last verified
- Feb 2024
- First submitted
- 28 Sep 2017
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Prebiotic on Growth, Feeding Progression and Neurodevelopment in Preterm Infants
- ClinicalTrials.gov ID
- NCT03306316
- Acronym / sponsor ID
- ColumbusCRI
- Conditions
- Preterm Infant, Development, Infant, Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- 4 Jul 2018 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 11 Oct 2017 (actual)
- 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.
This is a double blinded, randomized, controlled trial of prebiotic in infants born between 26 and 32 weeks gestational age. The investigators anticipate enrollment of 90 subjects in total and for the study to be completed in 18 months. The investigators anticipate collecting clinical data, anthropometrics, stool samples (requiring appropriate storage through analysis), salivary samples from mother and infant, discarded blood samples from baby after the standard care lab tests are done, a single, optional blood draw at the conclusion of the study, and subjecting infants to a neurodevelopmental survey at study completion.
The overall goal of this study is to test prebiotic administration to human milk-fed infants who are 700 gram to 1800 gram birthweight. The goal of this study will be addressed through one primary aim, a secondary aim, and exploratory aims, indicated below:
Primary aim: Compare weight, length, and head circumference Z-score growth between the study and placebo groups.
Secondary aim: Compare the time taken to achieve full feedings (135 mL/kg/day or more) between the study and placebo groups.
Exploratory aim 1: Compare neurobehavior, as measured by the validated Neonatal intensive care unit Network Neurobehavioral Scale (NNNS), between the study and placebo groups.
Exploratory aim 2: Compare fecal calprotectin levels to determine the impact of supplementation on reducing intestinal inflammation between the study and placebo groups.
Exploratory aim 3: Compare fecal microbiome between the prebiotic and placebo groups, to determine whether there is a shift in microbial composition towards bifidobacteria and other microbes that are capable of metabolizing prebiotic.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Dietary Supplement: PrebioticExperimental Arm |
| Control | Placebo comparator | Dietary Supplement: Dextrose ControlPlacebo Control Arm |
Who may qualify
- Ages
- 7 to 10 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Preterm infants who meet the following inclusion criteria will be eligible for randomization:
Key exclusion criteria (11 listed)
- Infants with the following conditions or situations at the time of randomization will be excluded from the study:
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 |
|---|---|---|
| PrebioticAlso: Study productPrebiotic experimental group | Dietary supplement | Experimental |
| Dextrose ControlDextrose Control | Dietary supplement | Control |
Primary outcome
Weight
Time frame: Enrollment through study day 45
Compare weight
Length
Time frame: Enrollment through study day 45
Compare length
Head Circumference
Time frame: Enrollment through study day 45
Compare head circumference
1 secondary outcome
Adaptation
Time frame: Enrollment through study day 45
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 8 Feb 2024.
- 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.
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 Prebiotic in people with Preterm Infant and Development, Infant, run by Nationwide Children's Hospital 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 11 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 8 Feb 2024. 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. Some participants in this study may receive a placebo. 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 (time frame: Enrollment through study day 45). The study lists 3 primary outcomes in all. 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 8 Feb 2024.