Deglutition Disorders in InfantsNCT03892811
Evaluation of the Effect of Flow Rate on Swallowing Function in Young Infants
An observational study of Deglutition Disorders in Infants and Bottle Feeding, run by Boston Children's Hospital.
Trial summary
The purpose of this study is to evaluate the effect of nipple flow rate on swallowing function in infants less than 3 months corrected age (up to 11 weeks and 6 days) who have been referred for videofluoroscopic swallow study. Read more about this study
- Who is it for?
- Ages 12 hours to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Deglutition Disorders in Infants, Bottle Feeding
- What is being tested?
- Three study conditions
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2018to 30 Jan 2019
- Phase
- Observational
- 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 12 hours to 3 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants less than 3 months corrected age (up to 11 weeks and 6 days) who have been referred for video fluoroscopic swallow study.
Who may be able to join
- Infant less than 3 months corrected age
- Must be referred for video fluoroscopic swallow study (VFSS) at Boston Children's Hospital
Who cannot join
- Infant unsafe to trial all study conditions as determined by clinician(s) conducting the VFSS.
About this study
The purpose of this study is to evaluate the effect of nipple flow rate on swallowing function in infants less than 3 months corrected age (up to 11 weeks and 6 days) who have been referred for videofluoroscopic swallow study.
Read the detailed description
Feeding difficulties are common in infants born premature and with medical complexity, particularly those with congenital heart disease. One of the most common strategies for managing feeding difficulties is changing the milk flow rate of the bottle nipple. Milk flow is the rate at which milk transfers from the bottle to the infant's mouth. During swallowing, the vocal folds must close to prevent aspiration of fluid into the airway. When milk flow is fast, the infant must swallow frequently to clear the bolus of fluid and prevent aspiration; this is done at the expense of respiration. When the milk flow rate is slowed, the infant can swallow less frequently, allowing better integration of respiration, and has more time to coordinate an effective swallow. While there is some very limited evidence that slower milk flow rate improves feeding in infants born premature and with congenital heart disease, the underlying mechanisms for improvement of feeding remain unknown. This project will be the first to evaluate the effect of milk flow rate on swallowing function under fluoroscopy to better understanding how swallowing changes under different conditions of flow in young infants. This research will provide the evidence needed to support the use of this simple intervention (i.e., changing the flow rate) in infants at risk for feeding difficulty and swallowing dysfunction.
- Conditions
- Deglutition Disorders in Infants, Bottle Feeding
- Being tested
- Three study conditions
- Medical subject headings
- Bottle Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three study conditionsOther
Continuous fluoroscopy (at 30 frames/second) will be used for intermittent periods to capture 10 swallows in the initial sucking sequence of each of three study conditions: 1) Dr. Brown's Ultra-Preemie bottle nipple, 2) Dr. Brown's Preemie bottle nipple, and 3) Dr. Brown's Level 1 bottle nipple.
| Study group | Role | What they receive |
|---|---|---|
| Infants referred for swallow study | This is a within-subjects intervention study where each infant in the study will receive all three conditions.
The three study conditions are bottle-feeding with 1) Dr. Brown's Ultra-Preemie bottle nipple, 2) Dr. Brown's Preemie bottle nipple, and 3) Dr. Brown's Level 1 bottle nipple. Receives: Other: Three study conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
VFSS - number of sucks per swallow
Number of sucks per swallow for each of 10 swallows under each of the three study conditions.
Measured: Through completion of 10 swallows under each study condition, maximum of 1 minute per study condition.
VFSS - oral bolus control
Oral bolus control for each of 10 swallows under each of the three study conditions.
Measured: Through completion of 10 swallows under each study condition, maximum of 1 minute per study condition.
VFSS - location of swallow onset
Location of swallow onset for each of 10 swallows under each of the three study conditions.
Measured: Through completion of 10 swallows under each study condition, maximum of 1 minute per study condition.
VFSS - presence of pharyngonasal regurgitation
Presence of pharyngonasal regurgitation for each of 10 swallows under each of the three study conditions.
Measured: Through completion of 10 swallows under each study condition, maximum of 1 minute per study condition.
VFSS - presence of laryngeal penetration
Presence of laryngeal penetration for each of 10 swallows under each of the three study conditions.
Measured: Through completion of 10 swallows under each study condition, maximum of 1 minute per study condition.
VFSS - presence of aspiration (silent or non-silent)
Presence of aspiration (silent or non-silent) for each of 10 swallows under each of the three study conditions.
Measured: Through completion of 10 swallows under each study condition, maximum of 1 minute per study condition.
VFSS - presence of post-swallow residue
Presence of post-swallow residue for each of 10 swallows under each of the three study conditions.
Measured: Through completion of 10 swallows under each study condition, maximum of 1 minute per study condition.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start1 Feb 2018
- Primary completion30 Jan 2019
- Study completion30 Jan 2019
Why it stopped: IRB protocol was not approved by Boston Children's Hospital
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Deglutition Disorders in InfantsStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie DiPerna, Boston Children's Hospital
- Investigators
- Stephanie A DiPerna, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892811
- Sponsor's protocol ID
- IRB-P00028852
- Status last verified
- Jun 2021
- First submitted
- 6 Feb 2019
- Last updated
- 11 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be made available in a secure Database.
Publications
Pados BF, Park J, Dodrill P. Know the Flow: Milk Flow Rates From Bottle Nipples Used in the Hospital and After Discharge. Adv Neonatal Care. 2019 Feb;19(1):32-41. doi: 10.1097/ANC.0000000000000538.
PubMed 30028734Pados BF, Thoyre SM, Estrem HH, Park J, Knafl GJ, Nix B. Effects of milk flow on the physiological and behavioural responses to feeding in an infant with hypoplastic left heart syndrome. Cardiol Young. 2017 Jan;27(1):139-153. doi: 10.1017/S1047951116000251. Epub 2016 Mar 16.
PubMed 26982280
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Flow Rate on Swallowing Function in Young Infants
- ClinicalTrials.gov ID
- NCT03892811
- Acronym / sponsor ID
- IRB-P00028852
- Conditions
- Deglutition Disorders in Infants, Bottle Feeding
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: IRB protocol was not approved by Boston Children's Hospital
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 27 Mar 2019 (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.
The purpose of this study is to evaluate the effect of nipple flow rate on swallowing function in infants less than 3 months corrected age (up to 11 weeks and 6 days) who have been referred for videofluoroscopic swallow study.
Detailed description
Feeding difficulties are common in infants born premature and with medical complexity, particularly those with congenital heart disease. One of the most common strategies for managing feeding difficulties is changing the milk flow rate of the bottle nipple. Milk flow is the rate at which milk transfers from the bottle to the infant's mouth. During swallowing, the vocal folds must close to prevent aspiration of fluid into the airway. When milk flow is fast, the infant must swallow frequently to clear the bolus of fluid and prevent aspiration; this is done at the expense of respiration. When the milk flow rate is slowed, the infant can swallow less frequently, allowing better integration of respiration, and has more time to coordinate an effective swallow. While there is some very limited evidence that slower milk flow rate improves feeding in infants born premature and with congenital heart disease, the underlying mechanisms for improvement of feeding remain unknown. This project will be the first to evaluate the effect of milk flow rate on swallowing function under fluoroscopy to better understanding how swallowing changes under different conditions of flow in young infants. This research will provide the evidence needed to support the use of this simple intervention (i.e., changing the flow rate) in infants at risk for feeding difficulty and swallowing dysfunction.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants referred for swallow study | – | Other: Three study conditionsThis is a within-subjects intervention study where each infant in the study will receive all three conditions. The three study conditions are bottle-feeding with 1) Dr. Brown's Ultra-Preemie bottle nipple, 2) Dr. Brown's Preemie bottle nipple, and 3) Dr. Brown's Level 1 bottle nipple. |
Who may qualify
- Ages
- 12 hours to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants less than 3 months corrected age (up to 11 weeks and 6 days) who have been referred for video fluoroscopic swallow study.
Key inclusion criteria (2 listed)
- Infant less than 3 months corrected age
- Must be referred for video fluoroscopic swallow study (VFSS) at Boston Children's Hospital
Key exclusion criteria (1 listed)
- Infant unsafe to trial all study conditions as determined by clinician(s) conducting the VFSS.
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 |
|---|---|---|
| Three study conditionsContinuous fluoroscopy (at 30 frames/second) will be used for intermittent periods to capture 10 swallows in the initial sucking sequence of each of three study conditions: 1) Dr. Brown's Ultra-Preemie bottle nipple, 2) Dr. Brown's Preemie bottle nipple, and 3) Dr. Brown's Level 1 bottle nipple. | Other | Infants referred for swallow study |
Primary outcome
VFSS - number of sucks per swallow
Time frame: Through completion of 10 swallows under each study condition, maximum of 1 minute per study condition.
Number of sucks per swallow for each of 10 swallows under each of the three study conditions.
VFSS - oral bolus control
Time frame: Through completion of 10 swallows under each study condition, maximum of 1 minute per study condition.
Oral bolus control for each of 10 swallows under each of the three study conditions.
VFSS - location of swallow onset
Time frame: Through completion of 10 swallows under each study condition, maximum of 1 minute per study condition.
Location of swallow onset for each of 10 swallows under each of the three study conditions.
VFSS - presence of pharyngonasal regurgitation
Time frame: Through completion of 10 swallows under each study condition, maximum of 1 minute per study condition.
Presence of pharyngonasal regurgitation for each of 10 swallows under each of the three study conditions.
VFSS - presence of laryngeal penetration
Time frame: Through completion of 10 swallows under each study condition, maximum of 1 minute per study condition.
Presence of laryngeal penetration for each of 10 swallows under each of the three study conditions.
VFSS - presence of aspiration (silent or non-silent)
Time frame: Through completion of 10 swallows under each study condition, maximum of 1 minute per study condition.
Presence of aspiration (silent or non-silent) for each of 10 swallows under each of the three study conditions.
VFSS - presence of post-swallow residue
Time frame: Through completion of 10 swallows under each study condition, maximum of 1 minute per study condition.
Presence of post-swallow residue for each of 10 swallows under each of the three study conditions.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Background: PubMed 30028734Pados BF, Park J, Dodrill P. Know the Flow: Milk Flow Rates From Bottle Nipples Used in the Hospital and After Discharge. Adv Neonatal Care. 2019 Feb;19(1):32-41. doi: 10.1097/ANC.0000000000000538.
- Background: PubMed 26982280Pados BF, Thoyre SM, Estrem HH, Park J, Knafl GJ, Nix B. Effects of milk flow on the physiological and behavioural responses to feeding in an infant with hypoplastic left heart syndrome. Cardiol Young. 2017 Jan;27(1):139-153. doi: 10.1017/S1047951116000251. Epub 2016 Mar 16.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be made available in a secure Database.
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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.
Stephanie A DiPerna, MD principal investigator
Boston Children's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Deglutition Disorders in Infants and Bottle Feeding, run by Boston Children's Hospital.
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 2 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: withdrawn, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
VFSS - number of sucks per swallow (time frame: Through completion of 10 swallows under each study condition, maximum of 1 minute per study condition.). The study lists 7 primary outcomes in all. 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 NCT03892811, which also lists 2 linked publications.
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 11 Jun 2021.