An interventional study of NCPAP and Varibar® Thin Liquid Barium Sulfate for Suspension in Deglutition Disorders, Respiratory Distress Syndrome In Premature Infants and Respiratory Aspiration, sponsored by NYU Langone Health. Completed. Open to participants aged 34 Weeks to 45 Weeks. Per ClinicalTrials.gov, last updated 2019-09-25.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Prevention
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.
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.
710 studies on the registry are indexed under Deglutition Disorders; 219 are open to participants now.
This study's enrollment of 7 is below the median of 60 across 471 interventional studies indexed under Deglutition Disorders.
Browse Deglutition Disorders studies →NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: NCPAP · Dietary Supplement: Varibar® Thin Liquid Barium Sulfate for Suspension
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.
Device: NCPAP · Dietary Supplement: Varibar® Thin Liquid Barium Sulfate for Suspension
Does NCPAP induce dysphagia in neonates? Each baby will be evaluated for dysphagia (using fluoroscopy) while on NCPAP and off NCPAP.
Also known as: Continuous Positive Airway Pressure
Liquid barium is used as a contrast material to allow visualization of swallowed boluses under fluoroscopy.
Pharyngeal Phase Dysphagia
presence of atypical or disordered movements during the pharyngeal phase of swallowing
Time frame: <5 seconds post swallow trigger
Tracheal Aspiration
the occurrence of barium below the level of the true vocal cords
Time frame: <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
Time frame: <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).
Time frame: <5 seconds post swallow trigger
Nasopharyngeal Reflux
the occurrence of barium detected in the nasopharynx, posterior or superior to the velum
Time frame: <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).
Time frame: <5 seconds post swallow trigger
Recruitment Period: September 2014- August 2015. All participants were recruited from the Neonatal Intensive Care Unit (NICU) at Winthrop University Hospital, Mineola, NY.
| Milestone | VFSS on nCPAP Then Off nCPAP |
|---|---|
| Started | 7 |
| Completed | 7 |
| Not completed | 0 |
presence of atypical or disordered movements during the pharyngeal phase of swallowing
| Participants | on NCPAP | Off NCPAP |
|---|---|---|
| Pharyngeal Phase Dysphagia | 7 | 7 |
the occurrence of barium below the level of the true vocal cords
| percentage of aspiration | on NCPAP | Off NCPAP |
|---|---|---|
| Tracheal Aspiration | 33.5 ± 9.4 | 14.6 ± 7.0 |
Will be measuredmeasured by deep penetration, the occurrence of barium underneath the epiglottis, in the laryngeal vestibule to the level of the vocal folds
| percentage of deep penetration | on NCPAP | Off NCPAP |
|---|---|---|
| Percentage of Laryngeal Length | 43.7 ± 15.4 | 25.3 ± 8.8 |
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).
| Participants | on NCPAP | Off NCPAP |
|---|---|---|
| Silent Aspiration | 7 | 7 |
the occurrence of barium detected in the nasopharynx, posterior or superior to the velum
| percentage of nasopharyngeal reflux | on NCPAP | Off NCPAP |
|---|---|---|
| Nasopharyngeal Reflux | 42.8 ± 48.5 | 44.2 ± 45.4 |
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).
| participants | on NCPAP | Off NCPAP |
|---|---|---|
| absent | 1 | 3 |
| mild | 4 | 4 |
| severe | 2 | 0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| on NCPAP | — | 0/7 (0%) | 0/7 (0%) |
| Off NCPAP | — | 0/7 (0%) | 0/7 (0%) |
| Age, Customized(weeks) | VFSS on nCPAP Then Off nCPAP |
|---|---|
| Mean | 37 (34.1 to 40.1) |
| Sex: Female, Male(Participants) | VFSS on nCPAP Then Off nCPAP |
|---|---|
| Female | 2 |
| Male | 5 |
| Race (NIH/OMB)(Participants) | VFSS on nCPAP Then Off nCPAP |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 4 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | VFSS on nCPAP Then Off nCPAP |
|---|---|
| United States | 7 |
No study locations are listed for this record.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
NYU Langone Health