Deglutition DisordersNCT02661256
Effect of Nasal Continuous Positive Airway Pressure on The Pharyngeal Swallow in Neonates
A study testing NCPAP and Varibar® Thin Liquid Barium Sulfate for Suspension in people with Deglutition Disorders and Respiratory Distress Syndrome In Premature Infants, run by NYU Langone Health.
Trial summary
Oral feeding of neonates while on nasal continuous positive airway pressure (NCPAP) is a common practice in many neonatal intensive care units (NICU) all over the country. However the safety of such practice has never been established. Read more about this study
- Who is it for?
- Ages 34 to 45 weeks
- Conditions the study is for
- Deglutition Disorders, Respiratory Distress Syndrome In Premature Infants, Respiratory Aspiration
- What is being tested?
- NCPAP and Varibar® Thin Liquid Barium Sulfate for Suspension
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 34 to 45 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants in neonatal ICU requiring NCPAP and tolerating at least 50% of their total required intake by mouth from a bottle, as determined by their medical team.
Who cannot join
- Infants with other comorbidity such as upper airway anomalies, brain injury neuromuscular disease, life threatening congenital disease. Any symptomatic intercurrent acute disease e.g. infectious disease
About this study
Oral feeding of neonates while on nasal continuous positive airway pressure (NCPAP) is a common practice in many neonatal intensive care units (NICU) all over the country. However the safety of such practice has never been established. The Investigators hypothesize that mechanoreceptors, which should perceive sensory input from the liquid bolus, may be altered by the reception of pressurized airflow provided by the NCPAP, hence increase risk of aspiration. In this study, changes in the pharyngeal phase of swallowing were identified using video fluoroscopic swallow studies (VFSS) for infants while on NCPAP as compared to off NCPAP.
Read the detailed description
Preterm infants with underdeveloped lungs and term infants with cardio-respiratory illness frequently need to be placed on ventilatory assistance. Nasal Continuous Positive Airway Pressure (NCPAP) has been proven to be an effective mode of noninvasive ventilation in neonates, as it delivers positive pressure to the airway throughout the respiratory cycle. NCPAP works by improving the breathing pattern in neonates; it increases the mean airway pressure, stents the upper airway, decreases proximal airway resistance, reduces physiological dead space, optimizes lung recruitment and improves diaphragmatic function. While many infants in the Neonatal Intensive Care Units (NICUs) require NCPAP, many of their other medical and developmental needs such as initiating oral feedings need to be addressed. Oral feeding of neonates while on NCPAP is a common practice in many NICUs, however the effect of such practice on neonatal swallowing mechanism has never been investigated.
Swallowing is a complex sensorimotor function that allows infant to safely and effectively ingest liquid nutrition. The ability of an infant to successfully feed is dependent on the precise interconnection of anatomy, physiology and neurology pathways. Afferent sequences play an integral role in the infant swallowing mechanism as sensory feedback is required during all phases of swallowing to allow appropriate positioning of anatomic structures, as well as to modulate the strength, velocity, and timing of muscle contractions. Sensory information is received from various types of sensory receptors distributed throughout the oral cavity, pharynx, larynx and esophagus. Localized areas of the infant's anatomy are known to have particular types of sensory receptors that are excited by specific stimuli which elicit appropriate motor movements.
One of the most densely populated sensory receptors are the mechanoreceptors which are sensitive to touch and pressure to help decipher the shape, texture, size and temperature of the bolus about to be swallowed. The mechanoreceptors are also sensitive to the pressure and movement of air flow during breathing.
The sensations perceived by these receptors are responsible for sending afferent sensory information to the medullary region of the brainstem where they are processed by the central pattern generators (CPGs). CPGs are composed of dedicated networks of interneurons that are responsible to sequence and activate different motor neurons at specified intensities to generate motor patterns. Both the swallowing CPG and the respiratory CPG are housed within the medulla. The close proximity of these neurons allows for precise swallow and breathing coordination. A close interrelationship between the swallowing and respiratory processes is further evident as they encompass shared anatomic structures and muscular components within the pharynx, and act as physiologically and biomechanically reciprocal events.
This close interrelationship between swallowing and breathing has led to some controversy and difference in opinion among neonatologists on the decision to start oral feedings while on NCPAP. Although there is no research directly related to the effect of NCPAP on swallowing process in neonates, NCPAP has been reported to induce dilatation of the laryngeal opening in preterm infants and inhibit the swallow reflex in adults.
For preterm infants, some neonatologists advocate initiation of oral feeds at 34 weeks gestational age, even if they require NCPAP; others strictly wait for NCPAP to be discontinued before oral feeding is established, fearing that infants may have difficulty coordinating breathing and swallowing acts, resulting in airway compromise. For term infants, many propose that oral feedings can be established once physiologic stability is demonstrated, either with or without NCPAP. Such controversies exist due to lack of evidence on the effect(s) of NCPAP on swallowing safety in human neonates.
To our knowledge no studies have been completed on human infants to evaluate the effect of NCPAP on the pharyngeal swallowing mechanism. Previous studies utilizing neonatal lambs, revealed that the application of NCPAP had no deleterious effect on cardiopulmonary safety, feeding efficiency and on nutritive swallowing- breathing coordination.
This study was designed with the aim to effectively assess the effects of NCPAP on the pharyngeal swallow mechanism in human neonates. The investigators hypothesize that the presence of NCPAP will lead to alterations in the sensorimotor sequence of the pharyngeal swallowing mechanism, increasing the risk for airway compromise and aspiration. The mechanoreceptors, which perceive sensory input from the liquid bolus, may be altered by the reception of continuous stream of airflow, provided by the NCPAP.
- Conditions
- Deglutition Disorders, Respiratory Distress Syndrome In Premature Infants, Respiratory Aspiration, Newborn, Premature
- Being tested
- NCPAP, Varibar® Thin Liquid Barium Sulfate for Suspension
- Keywords
- pharyngeal swallow, airway compromise, NICU
- Medical subject headings
- Deglutition Disorders, Respiratory Distress Syndrome In Premature Infants, Respiratory Aspiration, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NCPAPDevice
Also called Continuous Positive Airway Pressure
Does NCPAP induce dysphagia in neonates? Each baby will be evaluated for dysphagia (using fluoroscopy) while on NCPAP and off NCPAP.
Varibar® Thin Liquid Barium Sulfate for SuspensionDietary supplement
Liquid barium is used as a contrast material to allow visualization of swallowed boluses under fluoroscopy.
| Study group | Role | What they receive |
|---|---|---|
| on NCPAP | Active comparator | Once consented, each participant underwent a video fluoroscopic swallow study (VFSS) while NCPAP was administered via a RAM cannula® (intervention). With the NCPAP turned on each participant was fed room temperature thin liquid barium (Varibar® Thin Liquid Barium Sulfate for Suspension) from a standard bottle (60ml Similac® Volu-Feeder® with an attached Similac® Infant Nipple and Ring (standard flow), a total of 20 swallows were recorded. These swallows were termed "on NCPAP" swallows. The swallows were assessed in real time for any swallowing dysfunction. Receives: Device: NCPAP; Dietary Supplement: Varibar® Thin Liquid Barium Sulfate for Suspension |
| Off NCPAP | Active comparator | Immediately following the "on NCPAP" condition, an additional 20 swallows were recorded under VFSS with the NCPAP turned off (intervention). These swallows were termed "off NCPAP" swallows. Receives: Device: NCPAP; Dietary Supplement: Varibar® Thin Liquid Barium Sulfate for Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharyngeal Phase Dysphagia
presence of atypical or disordered movements during the pharyngeal phase of swallowing
Measured: <5 seconds post swallow trigger
Secondary outcomes (5)
Tracheal Aspiration
the occurrence of barium below the level of the true vocal cords
Measured: <5 seconds post swallow trigger
Percentage of Laryngeal Length
Will be measuredmeasured by deep penetration, the occurrence of barium underneath the epiglottis, in the laryngeal vestibule to the level of the vocal folds
Measured: <2 seconds post swallow trigger
Silent Aspiration
The occurrence of barium below the level of the vocal folds (aspiration) with no occurrence of cough (silent). This is a measure of absence of a cough during aspiration (silent aspiration).
Measured: <5 seconds post swallow trigger
Nasopharyngeal Reflux
the occurrence of barium detected in the nasopharynx, posterior or superior to the velum
Measured: <2 seconds post swallow trigger
Pharyngeal Residue
the presence of residual barium coating the pharyngeal walls, pooling in the vallecula or pyriform sinuses post swallow (absent/mild/severe). This measure is subjective (mild = light coating and sever = significant coating of residual barium).
Measured: <5 seconds post swallow trigger
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2016 (estimated)
- Study startJun 2014
- Primary completionAug 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Deglutition DisordersStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nazeeh Hanna, MD, Principal investigator, NYU Langone Winthrop University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02661256
- Sponsor's protocol ID
- WUH 14018
- Status last verified
- Sep 2019
- First submitted
- 4 Jan 2016
- Last updated
- 25 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nasal Continuous Positive Airway Pressure on The Pharyngeal Swallow in Neonates
- ClinicalTrials.gov ID
- NCT02661256
- Acronym / sponsor ID
- WUH 14018
- Conditions
- Deglutition Disorders, Respiratory Distress Syndrome In Premature Infants, Respiratory Aspiration, Newborn, Premature
- Keywords
- pharyngeal swallow, airway compromise, NICU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 22 Jan 2016 (estimated)
- Results
- Posted 23 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Oral feeding of neonates while on nasal continuous positive airway pressure (NCPAP) is a common practice in many neonatal intensive care units (NICU) all over the country. However the safety of such practice has never been established. The Investigators hypothesize that mechanoreceptors, which should perceive sensory input from the liquid bolus, may be altered by the reception of pressurized airflow provided by the NCPAP, hence increase risk of aspiration. In this study, changes in the pharyngeal phase of swallowing were identified using video fluoroscopic swallow studies (VFSS) for infants while on NCPAP as compared to off NCPAP.
Detailed description
Preterm infants with underdeveloped lungs and term infants with cardio-respiratory illness frequently need to be placed on ventilatory assistance. Nasal Continuous Positive Airway Pressure (NCPAP) has been proven to be an effective mode of noninvasive ventilation in neonates, as it delivers positive pressure to the airway throughout the respiratory cycle. NCPAP works by improving the breathing pattern in neonates; it increases the mean airway pressure, stents the upper airway, decreases proximal airway resistance, reduces physiological dead space, optimizes lung recruitment and improves diaphragmatic function. While many infants in the Neonatal Intensive Care Units (NICUs) require NCPAP, many of their other medical and developmental needs such as initiating oral feedings need to be addressed. Oral feeding of neonates while on NCPAP is a common practice in many NICUs, however the effect of such practice on neonatal swallowing mechanism has never been investigated.
Swallowing is a complex sensorimotor function that allows infant to safely and effectively ingest liquid nutrition. The ability of an infant to successfully feed is dependent on the precise interconnection of anatomy, physiology and neurology pathways. Afferent sequences play an integral role in the infant swallowing mechanism as sensory feedback is required during all phases of swallowing to allow appropriate positioning of anatomic structures, as well as to modulate the strength, velocity, and timing of muscle contractions. Sensory information is received from various types of sensory receptors distributed throughout the oral cavity, pharynx, larynx and esophagus. Localized areas of the infant's anatomy are known to have particular types of sensory receptors that are excited by specific stimuli which elicit appropriate motor movements.
One of the most densely populated sensory receptors are the mechanoreceptors which are sensitive to touch and pressure to help decipher the shape, texture, size and temperature of the bolus about to be swallowed. The mechanoreceptors are also sensitive to the pressure and movement of air flow during breathing.
The sensations perceived by these receptors are responsible for sending afferent sensory information to the medullary region of the brainstem where they are processed by the central pattern generators (CPGs). CPGs are composed of dedicated networks of interneurons that are responsible to sequence and activate different motor neurons at specified intensities to generate motor patterns. Both the swallowing CPG and the respiratory CPG are housed within the medulla. The close proximity of these neurons allows for precise swallow and breathing coordination. A close interrelationship between the swallowing and respiratory processes is further evident as they encompass shared anatomic structures and muscular components within the pharynx, and act as physiologically and biomechanically reciprocal events.
This close interrelationship between swallowing and breathing has led to some controversy and difference in opinion among neonatologists on the decision to start oral feedings while on NCPAP. Although there is no research directly related to the effect of NCPAP on swallowing process in neonates, NCPAP has been reported to induce dilatation of the laryngeal opening in preterm infants and inhibit the swallow reflex in adults.
For preterm infants, some neonatologists advocate initiation of oral feeds at 34 weeks gestational age, even if they require NCPAP; others strictly wait for NCPAP to be discontinued before oral feeding is established, fearing that infants may have difficulty coordinating breathing and swallowing acts, resulting in airway compromise. For term infants, many propose that oral feedings can be established once physiologic stability is demonstrated, either with or without NCPAP. Such controversies exist due to lack of evidence on the effect(s) of NCPAP on swallowing safety in human neonates.
To our knowledge no studies have been completed on human infants to evaluate the effect of NCPAP on the pharyngeal swallowing mechanism. Previous studies utilizing neonatal lambs, revealed that the application of NCPAP had no deleterious effect on cardiopulmonary safety, feeding efficiency and on nutritive swallowing- breathing coordination.
This study was designed with the aim to effectively assess the effects of NCPAP on the pharyngeal swallow mechanism in human neonates. The investigators hypothesize that the presence of NCPAP will lead to alterations in the sensorimotor sequence of the pharyngeal swallowing mechanism, increasing the risk for airway compromise and aspiration. The mechanoreceptors, which perceive sensory input from the liquid bolus, may be altered by the reception of continuous stream of airflow, provided by the NCPAP.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| on NCPAP | Active comparator | Device: NCPAP, Dietary Supplement: Varibar® Thin Liquid Barium Sulfate for SuspensionOnce consented, each participant underwent a video fluoroscopic swallow study (VFSS) while NCPAP was administered via a RAM cannula® (intervention). With the NCPAP turned on each participant was fed room temperature thin liquid barium (Varibar® Thin Liquid Barium Sulfate for Suspension) from a standard bottle (60ml Similac® Volu-Feeder® with an attached Similac® Infant Nipple and Ring (standard flow), a total of 20 swallows were recorded. These swallows were termed "on NCPAP" swallows. The swallows were assessed in real time for any swallowing dysfunction. |
| Off NCPAP | Active comparator | Device: NCPAP, Dietary Supplement: Varibar® Thin Liquid Barium Sulfate for SuspensionImmediately following the "on NCPAP" condition, an additional 20 swallows were recorded under VFSS with the NCPAP turned off (intervention). These swallows were termed "off NCPAP" swallows. |
Who may qualify
- Ages
- 34 to 45 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants in neonatal ICU requiring NCPAP and tolerating at least 50% of their total required intake by mouth from a bottle, as determined by their medical team.
Key exclusion criteria (1 listed)
- Infants with other comorbidity such as upper airway anomalies, brain injury neuromuscular disease, life threatening congenital disease. Any symptomatic intercurrent acute disease e.g. infectious disease
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 |
|---|---|---|
| NCPAPAlso: Continuous Positive Airway PressureDoes NCPAP induce dysphagia in neonates? Each baby will be evaluated for dysphagia (using fluoroscopy) while on NCPAP and off NCPAP. | Device | Off NCPAP, on NCPAP |
| Varibar® Thin Liquid Barium Sulfate for SuspensionLiquid barium is used as a contrast material to allow visualization of swallowed boluses under fluoroscopy. | Dietary supplement | Off NCPAP, on NCPAP |
Primary outcome
Pharyngeal Phase Dysphagia
Time frame: <5 seconds post swallow trigger
presence of atypical or disordered movements during the pharyngeal phase of swallowing
5 secondary outcomes
Tracheal Aspiration
Time frame: <5 seconds post swallow trigger
Percentage of Laryngeal Length
Time frame: <2 seconds post swallow trigger
Silent Aspiration
Time frame: <5 seconds post swallow trigger
Nasopharyngeal Reflux
Time frame: <2 seconds post swallow trigger
Pharyngeal Residue
Time frame: <5 seconds post swallow trigger
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Nazeeh Hanna, MD principal investigator
NYU Langone Winthrop University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing NCPAP and Varibar® Thin Liquid Barium Sulfate for Suspension in people with Deglutition Disorders and Respiratory Distress Syndrome In Premature Infants, run by NYU Langone Health.
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 25 Sep 2019. 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?
Yes. Results are posted in the registry (first posted 23 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pharyngeal Phase Dysphagia (time frame: <5 seconds post swallow trigger). 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 25 Sep 2019.