Esophageal Stimulation for Neonatal Feeding Disorder

(FAST Trial)

Overseen By Patty Luzader

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Sudarshan Jadcherla

Disqualifiers: Chromosomal anomalies, Craniofacial malformations, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks or until discharge

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Esophageal Stimulation with High Resolution Esophageal Manometry for Neonatal Feeding Disorder?

High-resolution esophageal manometry (HREM) is used to evaluate esophageal function, and studies have shown it can help assess esophageal motility disorders, which are related to feeding issues. This suggests that HREM might be useful in understanding and potentially improving feeding disorders in neonates. ^{1 2 3 4 5}

Is esophageal stimulation safe for humans?

The research articles do not provide specific safety data for esophageal stimulation in humans, focusing instead on diagnostic evaluations and esophageal function assessments. ^{1 2 4 6 7}

How is the treatment Esophageal Stimulation with High Resolution Esophageal Manometry different from other treatments for neonatal feeding disorder?

This treatment is unique because it uses high-resolution manometry (HRM) to precisely measure and analyze the pressure and movement in the esophagus, which helps in understanding and addressing feeding disorders in newborns. Unlike other treatments, it provides detailed insights into esophageal function, potentially leading to more targeted and effective interventions. ^{1 2 3 4 8}

What is the purpose of this trial?

The goal of this study is to demonstrate safety, feasibility, and efficacy of a novel pharyngo-esophageal stimulation technique in restoring aerodigestive and swallowing functions in select infants at-risk for chronic gavage tube feeding or gastrostomy. The main aims are: * To provide consistent activation of deglutition (the process of swallowing), swallowing-airway interactions, and peristalsis in order to decrease the risk of home tube feeding. * To examine whether physical and manometric evidence-guided interventions and biofeedback will improve compliance, minimize parental stress, and increase satisfaction and perceived self-confidence with infant feeding. Participants will have weekly pharyngo-esophageal stimulation guided by High Resolution Impedance Manometry (HRIM) for 4 weeks or until discharge, oral nutritive stimulation of at least 5 mL of prescribed milk with each feed, and weekly parental education and feedback regarding feeding progress.

Research Team

Sudarshan Jadcherla

Principal Investigator

Nationwide Children's Hospital

Eligibility Criteria

This trial is for infants at least 37 weeks postmenstrual age in the NICU who are not taking full oral feeds and have been referred to a feeding disorder program. They must show certain reflexes on initial manometry, which measures swallowing functions.

Inclusion Criteria

Your digestive system is exhibiting its normal reflexes at the start of testing.

My baby is in the NICU, over 37 weeks old, and not fully feeding by mouth.

I have been referred for feeding issues and need a special test to diagnose it.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Weekly pharyngo-esophageal stimulation guided by High Resolution Impedance Manometry (HRIM) and oral nutritive stimulation for 4 weeks or until discharge

4 weeks or until discharge

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Esophageal Stimulation with High Resolution Esophageal Manometry

Trial Overview The study tests a new therapy that stimulates the throat and esophagus to improve swallowing and reduce the need for tube feeding in infants with eating difficulties. It includes weekly stimulation sessions, milk feedings, and parental education for up to 4 weeks.

Participant Groups

Group I: Infants with Complex Feeding Difficulties Experimental Treatment 1 Intervention

Weekly manometric esophageal stimulation as well as consistent nutritive oral feeding therapy

Who Is Running the Clinical Trial?

Sudarshan Jadcherla

Lead Sponsor

Trials

3

Recruited

230+

Findings from Research

In a study of 155 patients with non-obstructive dysphagia, high-resolution esophageal manometry (HREM) revealed that 49% had normal results, while the most common motility disorder was ineffective esophageal motility, affecting 20% of patients.

Factors such as being male, having erosive esophagitis, and using calcium channel blockers were identified as significant predictors of esophageal motility disorders, with men being five times more likely to have achalasia compared to women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gender, medication use and other factors associated with esophageal motility disorders in non-obstructive dysphagia. Kamal, A., Shakya, S., Lopez, R., et al.[2022]

In a study involving 14 healthy controls and 41 patients with non-obstructive dysphagia, the esophageal impedance integral (EII) ratio and bolus flow time (BFT) were found to be significant indicators of dysphagia, helping to differentiate between dysphagia and non-dysphagia patients.

The EII ratio, particularly when measured in an upright position, showed a strong correlation with dysphagia symptoms, suggesting it could be a valuable tool for diagnosing patients who have normal esophageal motility but still experience swallowing difficulties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-resolution impedance manometry parameters enhance the esophageal motility evaluation in non-obstructive dysphagia patients without a major Chicago Classification motility disorder. Carlson, DA., Omari, T., Lin, Z., et al.[2022]

Intraoperative high resolution manometry (HRM) during laparoscopic antireflux procedures in seven pediatric patients showed that postoperative esophagogastric junction (EGJ) pressures were significantly higher than preoperative pressures, indicating improved esophageal function after surgery.

The study found that 71.4% of patients had complete correction of sliding hernias, and there were no relapses of gastroesophageal reflux post-surgery, suggesting that HRM can help optimize surgical outcomes in children with neurological impairment or esophageal atresia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High Resolution Manometry Guidance During Laparoscopic Fundoplication in Pediatric Surgically "Fragile" Patients: Preliminary Report. Caruso, AM., Milazzo, M., Tulone, V., et al.[2020]

High resolution manometry (HRM) is a safe and tolerable method for assessing esophageal function in neonates, as demonstrated in a study involving 11 infants.

The study found that neonates exhibit different esophageal peristalsis patterns compared to adults, with some showing incomplete peristalsis and variations in upper and lower esophageal sphincter pressures, indicating that their esophageal function is still developing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical application of high resolution manometry for examining esophageal function in neonates]. Li, ZH., Wang, DH., Dong, M., et al.[2012]

This study provides the first high-resolution esophageal manometry (HREM) parameters for children aged 9-16 years without dysphagia, highlighting significant differences from adult norms, which underscores the need for pediatric-specific standards.

The findings indicate that the resting pressures and contractile integrals in children are distinct from those in adults, suggesting that tailored catheters and protocols are necessary for accurately diagnosing esophageal motility disorders in the pediatric population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of high-resolution esophageal manometry in children without dysphagia. Kovacic, K., Kern, M., Pawela, L., et al.[2023]

The introduction of automated impedance-manometry (AIM) allows for combined analysis of impedance and manometry data, revealing subtle abnormalities in esophageal function in patients with nonobstructive dysphagia who previously showed normal results with conventional methods.

AIM analysis has the potential to predict postfundoplication dysphagia by identifying preoperative characteristics, enhancing the management of esophageal motor disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined impedance-manometry for the evaluation of esophageal disorders. Holloway, RH.[2022]

In a study of 13 children undergoing anti-reflux surgery, a higher pre-operative pressure-flow index was linked to increased post-operative dysphagia symptoms, indicating that esophageal function assessment is crucial before surgery.

The ramp pressure during bolus clearance was identified as the key factor influencing post-operative dysphagia, suggesting that monitoring this specific measure could help predict and manage dysphagia risks after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A study of dysphagia symptoms and esophageal body function in children undergoing anti-reflux surgery. Omari, T., Connor, F., McCall, L., et al.[2023]

The study analyzed swallowing functions in 25 neurologically impaired children with cerebral palsy using esophageal high-resolution manometry (HRM), revealing significant differences in swallowing parameters compared to non-neurologically impaired children.

Findings indicated that neurologically impaired children had lower pressures and shorter relaxation durations in the upper esophageal sphincter, which may increase the risk of inhalation and aspiration due to insufficient bolus clearance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Dysphagia and Inhalation Risk in Neurologically Impaired Children Using Esophageal High-Resolution Manometry with Swallowing Analysis. Caruso, AM., Bommarito, D., Girgenti, V., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Gender, medication use and other factors associated with esophageal motility disorders in non-obstructive dysphagia. [2022]

2. England pubmed.ncbi.nlm.nih.gov

High-resolution impedance manometry parameters enhance the esophageal motility evaluation in non-obstructive dysphagia patients without a major Chicago Classification motility disorder. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

High Resolution Manometry Guidance During Laparoscopic Fundoplication in Pediatric Surgically "Fragile" Patients: Preliminary Report. [2020]

4. China pubmed.ncbi.nlm.nih.gov

[Clinical application of high resolution manometry for examining esophageal function in neonates]. [2012]

5. England pubmed.ncbi.nlm.nih.gov

Characteristics of high-resolution esophageal manometry in children without dysphagia. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Combined impedance-manometry for the evaluation of esophageal disorders. [2022]

7. England pubmed.ncbi.nlm.nih.gov

A study of dysphagia symptoms and esophageal body function in children undergoing anti-reflux surgery. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of Dysphagia and Inhalation Risk in Neurologically Impaired Children Using Esophageal High-Resolution Manometry with Swallowing Analysis. [2022]