Premature InfantsNCT00798824
The Impact of Nasogastric Indwelling Versus Oral Intermittent Tube Feeding Methods on Premature Infants
A study testing Indwelling nasogastric tube placement, Intermittent orogastric tube placement and Nasogastric tube in people with Premature Infants, run by University of Manitoba at 1 site in Canada.
Trial summary
This clinical pilot trial is being conducted to learn more about the infant's feeding behavior while being fed by indwelling nasogastric tube placement or by intermittent oral tube placement. Read more about this study
- Who is it for?
- Ages 30 to 33 weeksHealthy volunteers can take part
- Conditions the study is for
- Premature Infants
- What is being tested?
- Indwelling nasogastric tube placement, Intermittent orogastric tube placement and Nasogastric tube
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2008to Dec 2009
- 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 30 to 33 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Premature infants born between 30-33 and 6/7th weeks gestation are an appropriate size for gestational age, are not on Oxygen are of any race, sex and require tube feeding and are less than 34 and 3/7th weeks gestation.
Who cannot join
- infants with neurological abnormalities or insults, IVH greater than a grade of two, PVL, birth asphyxia, seizures, cord has less than 7.0 ph, chest compressions, infants who require abstinence scoring, infants with major congenital anomalies or major genetic anomalies that impact feeding ability such as diaphragmatic hernia and cleft palate, major cardiac defects, infants who develop necrotizing enterocolitis, infants who received more than 14 days of intubation or CPAP or oxygen by nasal prongs and infants of diabetic or alcoholic mothers.
Trial locations and contacts
1 site in 1 country.
About this study
This clinical pilot trial is being conducted to learn more about the infant's feeding behavior while being fed by indwelling nasogastric tube placement or by intermittent oral tube placement.
Healthy preterm infants who are transitioning from gavage to oral feedings via oral intermittent tube insertion may achieve full oral feeds by bottle/breast at an earlier gestational age than infants feeding with indwelling tubes and may be ready for earlier discharge.
Read the detailed description
Independent feeding is often one of the last competencies that the premature infant must accomplish prior to discharge from hospital. Feeding is a complex task for the premature infant to accomplish and it often takes many weeks for the infant to learn how to feed. Therefore, tube feeding is required for the infant to ingest adequate nutrition during the transition from gavage feeding to oral feeding. Both intermittent oral gavage tube placement and indwelling nasogastric tube placement are acceptable methods for feeding preterm infants. However, it is not known which tube feeding method will support an expedited transition to oral feeding. The choice of using one method over the other is currently based on the individual health care provider's opinion or historical institutional practices and insufficient evidence is available to guide tube feeding practices.
- Conditions
- Premature Infants
- Being tested
- Indwelling nasogastric tube placement, Intermittent orogastric tube placement, Nasogastric tube, Oral gastric tube
- Keywords
- tube feeding, premature infant
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indwelling nasogastric tube placementProcedure or surgery
Also called Nasogastric tube
The premature infant is fed with an indwelling nasogastric tube during feeding transition.
Intermittent orogastric tube placementProcedure or surgery
Also called Oral gastric tube
The premature infant is fed with an intermittently placed orogastric tube during feeding transition.
Nasogastric tubeDevice
Premature infants will be fed with a nasogastric tube in place and their feeding behaviors will be noted till discharge.
Oral gastric tubeDevice
Premature infants will be fed with intermittent orogastric tube placement and their feeding behaviors will be noted till discharge.
| Study group | Role | What they receive |
|---|---|---|
| Indwelling nasogastric tube placement | Active comparator | Not described Receives: Procedure: Indwelling nasogastric tube placement; Device: Nasogastric tube |
| Intermittent orogastric tube placement | Active comparator | Not described Receives: Procedure: Intermittent orogastric tube placement; Device: Oral gastric tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational age of the last required tube feed.
Measured: Last required tube feed
Secondary outcomes (2)
Discharge date
Measured: Discharge date
The amount suckled per day
Measured: Discharge date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2008 (estimated)
- Study startAug 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature InfantsStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Investigators
- Judy A Kublick, Grad student, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00798824
- Sponsor's protocol ID
- B2008:072
- Status last verified
- Oct 2010
- First submitted
- 12 Sep 2008
- Last updated
- 13 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Nasogastric Indwelling Versus Oral Intermittent Tube Feeding Methods on Premature Infants
- ClinicalTrials.gov ID
- NCT00798824
- Acronym / sponsor ID
- B2008:072
- Conditions
- Premature Infants
- Keywords
- tube feeding, premature infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 26 Nov 2008 (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.
This clinical pilot trial is being conducted to learn more about the infant's feeding behavior while being fed by indwelling nasogastric tube placement or by intermittent oral tube placement.
Healthy preterm infants who are transitioning from gavage to oral feedings via oral intermittent tube insertion may achieve full oral feeds by bottle/breast at an earlier gestational age than infants feeding with indwelling tubes and may be ready for earlier discharge.
Detailed description
Independent feeding is often one of the last competencies that the premature infant must accomplish prior to discharge from hospital. Feeding is a complex task for the premature infant to accomplish and it often takes many weeks for the infant to learn how to feed. Therefore, tube feeding is required for the infant to ingest adequate nutrition during the transition from gavage feeding to oral feeding. Both intermittent oral gavage tube placement and indwelling nasogastric tube placement are acceptable methods for feeding preterm infants. However, it is not known which tube feeding method will support an expedited transition to oral feeding. The choice of using one method over the other is currently based on the individual health care provider's opinion or historical institutional practices and insufficient evidence is available to guide tube feeding practices.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indwelling nasogastric tube placement | Active comparator | Procedure: Indwelling nasogastric tube placement, Device: Nasogastric tube |
| Intermittent orogastric tube placement | Active comparator | Procedure: Intermittent orogastric tube placement, Device: Oral gastric tube |
Who may qualify
- Ages
- 30 to 33 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Premature infants born between 30-33 and 6/7th weeks gestation are an appropriate size for gestational age, are not on Oxygen are of any race, sex and require tube feeding and are less than 34 and 3/7th weeks gestation.
Key exclusion criteria (1 listed)
- infants with neurological abnormalities or insults, IVH greater than a grade of two, PVL, birth asphyxia, seizures, cord has less than 7.0 ph, chest compressions, infants who require abstinence scoring, infants with major congenital anomalies or major genetic anomalies that impact feeding ability such as diaphragmatic hernia and cleft palate, major cardiac defects, infants who develop necrotizing enterocolitis, infants who received more than 14 days of intubation or CPAP or oxygen by nasal prongs and infants of diabetic or alcoholic mothers.
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 |
|---|---|---|
| Indwelling nasogastric tube placementAlso: Nasogastric tubeThe premature infant is fed with an indwelling nasogastric tube during feeding transition. | Procedure or surgery | Indwelling nasogastric tube placement |
| Intermittent orogastric tube placementAlso: Oral gastric tubeThe premature infant is fed with an intermittently placed orogastric tube during feeding transition. | Procedure or surgery | Intermittent orogastric tube placement |
| Nasogastric tubePremature infants will be fed with a nasogastric tube in place and their feeding behaviors will be noted till discharge. | Device | Indwelling nasogastric tube placement |
| Oral gastric tubePremature infants will be fed with intermittent orogastric tube placement and their feeding behaviors will be noted till discharge. | Device | Intermittent orogastric tube placement |
Primary outcome
Gestational age of the last required tube feed.
Time frame: Last required tube feed
2 secondary outcomes
Discharge date
Time frame: Discharge date
The amount suckled per day
Time frame: Discharge date
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 13 Oct 2010.
Related trials for Premature Infants
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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.
Judy A Kublick, Grad student principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indwelling nasogastric tube placement, Intermittent orogastric tube placement and Nasogastric tube in people with Premature Infants, run by University of Manitoba at 1 site in Canada.
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 13 Oct 2010. 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 Canada. 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?
Gestational age of the last required tube feed. (time frame: Last required tube feed). 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 13 Oct 2010.