Skip to content

Effect of Nasal Continuous Positive Airway Pressure on The Pharyngeal Swallow in Neonates

Effect of Nasal Continuous Positive Airway Pressure on The Pharyngeal Swallow in Neonates

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02661256
Enrollment
7
Registered
2016-01-22
Start date
2014-06-30
Completion date
2015-09-30
Last updated
2019-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deglutition Disorders, Newborn, Premature, Respiratory Aspiration, Respiratory Distress Syndrome In Premature Infants

Keywords

pharyngeal swallow, airway compromise, NICU

Brief 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. 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.

Interventions

DEVICENCPAP

Does NCPAP induce dysphagia in neonates? Each baby will be evaluated for dysphagia (using fluoroscopy) while on NCPAP and off NCPAP.

DIETARY_SUPPLEMENTVaribar® Thin Liquid Barium Sulfate for Suspension

Liquid barium is used as a contrast material to allow visualization of swallowed boluses under fluoroscopy.

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
34 Weeks to 45 Weeks
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Pharyngeal Phase Dysphagia<5 seconds post swallow triggerpresence of atypical or disordered movements during the pharyngeal phase of swallowing

Secondary

MeasureTime frameDescription
Tracheal Aspiration<5 seconds post swallow triggerthe occurrence of barium below the level of the true vocal cords
Percentage of Laryngeal Length<2 seconds post swallow triggerWill be measuredmeasured by deep penetration, the occurrence of barium underneath the epiglottis, in the laryngeal vestibule to the level of the vocal folds
Silent Aspiration<5 seconds post swallow triggerThe 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).
Nasopharyngeal Reflux<2 seconds post swallow triggerthe occurrence of barium detected in the nasopharynx, posterior or superior to the velum
Pharyngeal Residue<5 seconds post swallow triggerthe 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).

Participant flow

Recruitment details

Recruitment Period: September 2014- August 2015. All participants were recruited from the Neonatal Intensive Care Unit (NICU) at Winthrop University Hospital, Mineola, NY.

Pre-assignment details

Chart review- 26 preterm infants on nCPAP. Weaned off nCPAP before approaching-10. Excluded- 4 (h/o upper airway anomalies, brain injury, etc.). Eligible-12. Declined consent -5. Consented-7. Screening and VFSS completed-7. Analyzed-7. None of the enrolled participants were excluded from the trial before assignment to groups.

Participants by arm

ArmCount
VFSS on nCPAP Then Off nCPAP
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. 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.
7
Total7

Baseline characteristics

CharacteristicVFSS on nCPAP Then Off nCPAP
Age, Customized37 weeks
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
3 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
4 Participants
Region of Enrollment
United States
7 Participants
Sex: Female, Male
Female
2 Participants
Sex: Female, Male
Male
5 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 70 / 7
serious
Total, serious adverse events
0 / 70 / 7

Outcome results

Primary

Pharyngeal Phase Dysphagia

presence of atypical or disordered movements during the pharyngeal phase of swallowing

Time frame: <5 seconds post swallow trigger

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
on NCPAPPharyngeal Phase Dysphagia7 Participants
Off NCPAPPharyngeal Phase Dysphagia7 Participants
Secondary

Nasopharyngeal Reflux

the occurrence of barium detected in the nasopharynx, posterior or superior to the velum

Time frame: <2 seconds post swallow trigger

ArmMeasureValue (MEAN)Dispersion
on NCPAPNasopharyngeal Reflux42.8 percentage of nasopharyngeal refluxStandard Deviation 48.5
Off NCPAPNasopharyngeal Reflux44.2 percentage of nasopharyngeal refluxStandard Deviation 45.4
Secondary

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

ArmMeasureValue (MEAN)Dispersion
on NCPAPPercentage of Laryngeal Length43.7 percentage of deep penetrationStandard Deviation 15.4
Off NCPAPPercentage of Laryngeal Length25.3 percentage of deep penetrationStandard Deviation 8.8
Secondary

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

ArmMeasureGroupValue (NUMBER)
on NCPAPPharyngeal Residueabsent1 participants
on NCPAPPharyngeal Residuemild4 participants
on NCPAPPharyngeal Residuesevere2 participants
Off NCPAPPharyngeal Residueabsent3 participants
Off NCPAPPharyngeal Residuemild4 participants
Off NCPAPPharyngeal Residuesevere0 participants
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
on NCPAPSilent Aspiration7 Participants
Off NCPAPSilent Aspiration7 Participants
Secondary

Tracheal Aspiration

the occurrence of barium below the level of the true vocal cords

Time frame: <5 seconds post swallow trigger

ArmMeasureValue (MEAN)Dispersion
on NCPAPTracheal Aspiration33.5 percentage of aspirationStandard Deviation 9.4
Off NCPAPTracheal Aspiration14.6 percentage of aspirationStandard Deviation 7

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026