Swallowing DysfunctionPhase 2NCT00859092
Promotion of Thickened Feeds to Manage Newborns With Feeding Difficulties
A Phase 2 study testing Simply Thick in people with Swallowing Dysfunction, run by David Oelberg, M.D. at 1 site in United States.
Trial summary
Swallowing dysfunction and delay of oral feeding skills in premature infants significantly delay discharge from the hospital. Thickening oral formula or breast milk feeds with commercial thickeners and rice cereal has been used in some nurseries with the goal of promoting development of adequate feeding skills. Read more about this study
- Who is it for?
- Ages Up to 3 months
- Conditions the study is for
- Swallowing Dysfunction
- What is being tested?
- Simply Thick
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Sep 2010
- Phase
- Phase 2
- 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 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- apneas and bradycardias with oral feedings
- oxygen desaturations with oral feedings
- excessive coughing or gagging with oral feedings
Who cannot join
- less than 32 weeks adjusted gestational age
- greater than 40 weeks adjusted gestational age
Trial locations and contacts
1 site in 1 country.
United States1 site
Sentara Norfolk General Hospital
Norfolk, Virginia, 23501
About this study
Swallowing dysfunction and delay of oral feeding skills in premature infants significantly delay discharge from the hospital. Thickening oral formula or breast milk feeds with commercial thickeners and rice cereal has been used in some nurseries with the goal of promoting development of adequate feeding skills. The objective of this pilot study is to examine the effect of thickened feeds on premature infants with oral feeding difficulties due to dysfunction secondary to immature swallowing.
Hypotheses:
- Thickened feeds will lead to a reduction in symptoms secondary to immature swallowing in 32-40 weeks gestational age infants when compared to non-thickened feeds
- Thickened feeds will promote transition to hospital discharge.
- Conditions
- Swallowing Dysfunction
- Being tested
- Simply Thick
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simply ThickDietary supplement
Also called Simply Thick®
Simply Thick® added to each bottle of formula or beast milk to create nectar or honey consistency
| Study group | Role | What they receive |
|---|---|---|
| Thickening of feeds | Experimental | Not described Receives: Dietary Supplement: Simply Thick |
| Removal of thickener | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elimination of symptoms associated with immature swallowing
Measured: 2 days
Secondary outcomes (1)
Promotes transition to discharge from hospital
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2009 (estimated)
- Study startMar 2008
- Primary completionJun 2009
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Swallowing DysfunctionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Oelberg, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David Oelberg, M.D., Eastern Virginia Medical School
- Investigators
- David Oelberg, MD, Principal investigator, Children's Hospital of The King's Daughters
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00859092
- Sponsor's protocol ID
- 07-12-FB-0305
- Status last verified
- Mar 2012
- First submitted
- 9 Mar 2009
- Last updated
- 9 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promotion of Thickened Feeds to Manage Newborns With Feeding Difficulties
- ClinicalTrials.gov ID
- NCT00859092
- Acronym / sponsor ID
- 07-12-FB-0305
- Conditions
- Swallowing Dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- David Oelberg, M.D.University, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 10 Mar 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.
Swallowing dysfunction and delay of oral feeding skills in premature infants significantly delay discharge from the hospital. Thickening oral formula or breast milk feeds with commercial thickeners and rice cereal has been used in some nurseries with the goal of promoting development of adequate feeding skills. The objective of this pilot study is to examine the effect of thickened feeds on premature infants with oral feeding difficulties due to dysfunction secondary to immature swallowing.
Hypotheses:
- Thickened feeds will lead to a reduction in symptoms secondary to immature swallowing in 32-40 weeks gestational age infants when compared to non-thickened feeds
- Thickened feeds will promote transition to hospital discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thickening of feeds | Experimental | Dietary Supplement: Simply Thick |
| Removal of thickener | No intervention | – |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- apneas and bradycardias with oral feedings
- oxygen desaturations with oral feedings
- excessive coughing or gagging with oral feedings
Key exclusion criteria (2 listed)
- less than 32 weeks adjusted gestational age
- greater than 40 weeks adjusted gestational age
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 |
|---|---|---|
| Simply ThickAlso: Simply Thick®Simply Thick® added to each bottle of formula or beast milk to create nectar or honey consistency | Dietary supplement | Thickening of feeds |
Primary outcome
Elimination of symptoms associated with immature swallowing
Time frame: 2 days
1 secondary outcome
Promotes transition to discharge from hospital
Time frame: one week
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 9 Mar 2012.
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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.
David Oelberg, MD principal investigator
Children's Hospital of The King's Daughters
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Simply Thick in people with Swallowing Dysfunction, run by David Oelberg, M.D. 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 3 inclusion and 2 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 9 Mar 2012. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Elimination of symptoms associated with immature swallowing (time frame: 2 days). 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 9 Mar 2012; AzTrials last refreshed its copy on 7 Nov 2026.