Feeding IntoleranceNCT00997854
Preterm Neonatal Feeding Protocol Comparing Feed Administration Time
A study testing Length of time for feed administration in people with Feeding Intolerance, run by Oregon Health and Science University at 1 site in United States.
Trial summary
Doctors have tried many different methods of feeding to try to decrease feeding intolerance in preterm babies so that they spend less time receiving liquid nutrition and have fewer problems with feeding intolerance. Read more about this study
- Who is it for?
- Ages Up to 32 weeksHealthy volunteers can take part
- Conditions the study is for
- Feeding Intolerance
- What is being tested?
- Length of time for feed administration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Oct 2010
- 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 32 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Any infant born at OHSU or transferred in from another facility whose birthweight is greater than 500 grams and less than 1500 grams, and whose gestational age is less than 32 weeks.
Who cannot join
- Any infant who has major anomalies including but not limited to *gastroschisis
- omphalocele
- bowel obstruction or atresia
- tracheo-esophageal fistula
- Hirschsprung's Disease
- congenital diaphragmatic hernia
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- congenital heart disease and other major syndromes
- infants who have started enteral feeds prior to entering the study
- Any infant whose birth weight is greater than or equal to 1500 grams or less than 500 grams
- Any infant whose gestational age is greater than 32 weeks.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Sciences University
Portland, Oregon, 97201
About this study
Doctors have tried many different methods of feeding to try to decrease feeding intolerance in preterm babies so that they spend less time receiving liquid nutrition and have fewer problems with feeding intolerance.
The purpose of this study is to test two different methods of feeding preterm babies in the hopes of identifying a method that will decrease some of the feeding intolerance that can occur when feeding premature babies.
- Conditions
- Feeding Intolerance
- Being tested
- Length of time for feed administration
- Keywords
- Feeding, Intolerance, Preterm, Bolus
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Length of time for feed administrationOther
Group 1 will consist of babies fed by bolus method, administered over no more than 30 minutes. Group 2 will be fed by slow infusion by pump over 2 hours.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Bolus Feeds | Active comparator | This group will receive feeds administered by bolus method over no more than 30 minutes per feed. Receives: Other: Length of time for feed administration |
| Group 2- Slow Infusion Feeds | Experimental | This group will receive feeds administered by slow infusion over pump for 2 hours. Receives: Other: Length of time for feed administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare feeding intolerance between these two groups as defined by the following criteria: the number of times that the signs and symptoms in an infant caused the perception of feeding intolerance with feeds paused for longer than one feeding.
Measured: Daily
Secondary outcomes (3)
To compare the number of days it takes the infant to reach full feeds.
Measured: After reaching full feeds.
To compare the number of days the infant requires intravenous nutrition.
Measured: After reaching full feeds.
To compare the number of days of overall hospitalization duration.
Measured: After patient discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding IntoleranceStudies 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
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sue Ann Smith, Oregon Health and Science University
- Investigators
- Sue Ann Smith, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00997854
- Sponsor's protocol ID
- 5376
- Status last verified
- Jun 2019
- First submitted
- 15 Oct 2009
- Last updated
- 10 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preterm Neonatal Feeding Protocol Comparing Feed Administration Time
- ClinicalTrials.gov ID
- NCT00997854
- Acronym / sponsor ID
- 5376
- Conditions
- Feeding Intolerance
- Keywords
- Feeding, Intolerance, Preterm, Bolus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 19 Oct 2009 (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.
Doctors have tried many different methods of feeding to try to decrease feeding intolerance in preterm babies so that they spend less time receiving liquid nutrition and have fewer problems with feeding intolerance.
The purpose of this study is to test two different methods of feeding preterm babies in the hopes of identifying a method that will decrease some of the feeding intolerance that can occur when feeding premature babies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 Bolus Feeds | Active comparator | Other: Length of time for feed administrationThis group will receive feeds administered by bolus method over no more than 30 minutes per feed. |
| Group 2- Slow Infusion Feeds | Experimental | Other: Length of time for feed administrationThis group will receive feeds administered by slow infusion over pump for 2 hours. |
Who may qualify
- Ages
- Up to 32 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Any infant born at OHSU or transferred in from another facility whose birthweight is greater than 500 grams and less than 1500 grams, and whose gestational age is less than 32 weeks.
Key exclusion criteria (10 listed)
- Any infant who has major anomalies including but not limited to *gastroschisis
- Any infant whose birth weight is greater than or equal to 1500 grams or less than 500 grams
- Any infant whose gestational age is greater than 32 weeks.
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 |
|---|---|---|
| Length of time for feed administrationGroup 1 will consist of babies fed by bolus method, administered over no more than 30 minutes. Group 2 will be fed by slow infusion by pump over 2 hours. | Other | Group 1 Bolus Feeds, Group 2- Slow Infusion Feeds |
Primary outcome
To compare feeding intolerance between these two groups as defined by the following criteria: the number of times that the signs and symptoms in an infant caused the perception of feeding intolerance with feeds paused for longer than one feeding.
Time frame: Daily
3 secondary outcomes
To compare the number of days it takes the infant to reach full feeds.
Time frame: After reaching full feeds.
To compare the number of days the infant requires intravenous nutrition.
Time frame: After reaching full feeds.
To compare the number of days of overall hospitalization duration.
Time frame: After patient discharge.
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 Jun 2019.
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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.
Sue Ann Smith, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Length of time for feed administration in people with Feeding Intolerance, run by Oregon Health and Science University 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 10 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 Jun 2019. 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?
To compare feeding intolerance between these two groups as defined by the following criteria: the number of times that the signs and symptoms in an infant caused the perception of feeding intolerance with feeds paused for longer than one feeding. (time frame: Daily). 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 Jun 2019.