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CompletedNCT02661256Updated Sep 25, 2019Results posted

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

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

Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Non-randomized
Ages
34 Weeks to 45 Weeks
Sex
All
01

Study 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.

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.

02

Conditions studied

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

Keywords

  • pharyngeal swallow
  • airway compromise
  • NICU
03

In context

Deglutition Disorders

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
34 Weeks to 45 Weeks
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Active comparator
    on 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.

    Device: NCPAP · Dietary Supplement: Varibar® Thin Liquid Barium Sulfate for Suspension

  • Active comparator
    Off NCPAP

    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

Interventions

  • DeviceNCPAP

    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

  • Dietary supplementVaribar® Thin Liquid Barium Sulfate for Suspension

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

06

What researchers measure

Primary outcomes

  1. Pharyngeal Phase Dysphagia

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

    Time frame: <5 seconds post swallow trigger

Secondary outcomes

  1. Tracheal Aspiration

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

    Time frame: <5 seconds post swallow trigger

  2. 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

  3. 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

  4. Nasopharyngeal Reflux

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

    Time frame: <2 seconds post swallow trigger

  5. 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

07

Results

Posted Jul 23, 2019
Limitations and caveats
Small number of subjects: Enrollment was stopped after 7 participants due to the documented risks associated with oral feeding on NCPAP. It was unethical to expose infants to harm after clear safety risk was identified.

Participant flow

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

Participant flow — Overall Study
MilestoneVFSS on nCPAP Then Off nCPAP
Started7
Completed7
Not completed0

Outcome measures

PrimaryPharyngeal Phase Dysphagia

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

Time frame:
<5 seconds post swallow trigger
Reported as:
Count of participants · Participants
Pharyngeal Phase Dysphagia
Participantson NCPAPOff NCPAP
Pharyngeal Phase Dysphagia77
SecondaryTracheal Aspiration

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

Time frame:
<5 seconds post swallow trigger
Reported as:
Mean · percentage of aspiration
Tracheal Aspiration
percentage of aspirationon NCPAPOff NCPAP
Tracheal Aspiration33.5 ± 9.414.6 ± 7.0
SecondaryPercentage 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
Reported as:
Mean · percentage of deep penetration
Percentage of Laryngeal Length
percentage of deep penetrationon NCPAPOff NCPAP
Percentage of Laryngeal Length43.7 ± 15.425.3 ± 8.8
SecondarySilent 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
Reported as:
Count of participants · Participants
Silent Aspiration
Participantson NCPAPOff NCPAP
Silent Aspiration77
SecondaryNasopharyngeal Reflux

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

Time frame:
<2 seconds post swallow trigger
Reported as:
Mean · percentage of nasopharyngeal reflux
Nasopharyngeal Reflux
percentage of nasopharyngeal refluxon NCPAPOff NCPAP
Nasopharyngeal Reflux42.8 ± 48.544.2 ± 45.4
SecondaryPharyngeal 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
Reported as:
Number · participants
Pharyngeal Residue
participantson NCPAPOff NCPAP
absent13
mild44
severe20

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
on NCPAP—0/7 (0%)0/7 (0%)
Off NCPAP—0/7 (0%)0/7 (0%)

Baseline characteristics

Age, Customized
Age, Customized(weeks)VFSS on nCPAP Then Off nCPAP
Mean37 (34.1 to 40.1)
Sex: Female, Male
Sex: Female, Male(Participants)VFSS on nCPAP Then Off nCPAP
Female2
Male5
Race (NIH/OMB)
Race (NIH/OMB)(Participants)VFSS on nCPAP Then Off nCPAP
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American3
White4
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(Participants)VFSS on nCPAP Then Off nCPAP
United States7
08

Study locations

No study locations are listed for this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02661256
Lead sponsor
NYU Langone Health
Responsible party
Sponsor
First posted
Jan 22, 2016
Start date
Jun 2014
Primary completion
Aug 2015
Completion
Sep 2015
Results posted
Jul 23, 2019
Last update
Sep 25, 2019

Study contacts

Nazeeh Hanna, MD
principal investigator · NYU Langone Winthrop University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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