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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to assist infants who have difficulty swallowing and may require long-term feeding tubes. The goal is to determine if gentle esophageal stimulation, using High Resolution Esophageal Manometry, can enhance their swallowing ability and reduce the need for tube feeding at home. The trial also seeks to alleviate parental stress and increase confidence in feeding their babies. Eligible infants are those in the NICU, at least 37 weeks postmenstrual age, and experiencing challenges with oral feeding. As an unphased trial, this study provides a unique opportunity for parents to contribute to innovative research that could significantly improve feeding outcomes for their infants.

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 prior data suggests that this pharyngo-esophageal stimulation technique is safe for infants with feeding difficulties?

Research shows that esophageal stimulation, guided by a special test to measure esophageal pressure, is generally safe for infants. Studies on this technique have not found any serious side effects. The procedure gently aids infants who struggle with swallowing and feeding independently.

Although researchers are still studying the treatment, its testing in infants suggests confidence in its safety. They would not proceed if major concerns existed. So far, the treatment appears well-tolerated, with no significant negative effects reported in similar past studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using esophageal stimulation for neonatal feeding disorders because it offers a novel approach that could enhance the feeding skills of infants with complex feeding difficulties. Unlike traditional methods that primarily focus on behavioral and nutritional interventions, this technique uses high resolution esophageal manometry to directly stimulate the esophagus. This innovative approach targets the neuromuscular function of the esophagus, potentially improving feeding efficiency and safety more directly and effectively than current therapies. By directly addressing the underlying physiological issues, this method holds the promise of providing faster and more sustainable improvements in feeding for affected infants.

What evidence suggests that this pharyngo-esophageal stimulation technique is effective for neonatal feeding disorder?

Research shows that certain techniques can improve swallowing. One study demonstrated that pharyngeal electrical stimulation led to short-term improvements in the muscle movements needed for swallowing. This trial will explore a similar approach, using Esophageal Stimulation with High Resolution Esophageal Manometry, to assist infants with complex feeding difficulties. The technique employs special equipment to guide therapy, triggering the swallow reflex and ensuring proper esophageal movement. This type of stimulation strengthens throat muscles, which is crucial for swallowing. These findings suggest that this approach may enhance infants' eating abilities and reduce their reliance on tube feeding. ^{2 5 6 7 8}

Who Is on the Research Team?

Sudarshan Jadcherla

Principal Investigator

Nationwide Children's Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-feeding-and-eating-disorders-10-2023-edf49

Esophageal Stimulation for Neonatal Feeding Disorder In a study of 155 patients with non-obstructive dysphagia, high-resolution esophageal manometry (HREM) revealed that 49% had normal results, while the most ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2892006/

High-Resolution Manometry and Impedance-pH ... Twenty-four hour esophageal impedance-pH monitoring in healthy preterm neonates: rate and characteristics of acid, weakly acidic, and weakly alkaline ...

3. frontiersin.org frontiersin.org/journals/pediatrics/articles/10.3389/fped.2022.806072/full

Characterizing Esophageal Motility in Neonatal Intensive ... Patients and Methods: High resolution manometry with impedance (HRIM) was used to investigate esophageal motility and EGJ function in patients ...

4. journals.physiology.org journals.physiology.org/doi/10.1152/japplphysiol.00516.2024

Pharyngeal electrical stimulation favorably modifies ... Our study evaluated this effect of PES in healthy individuals using high-resolution manometry impedance. PES showed short-term improved pharyngeal contractility ...

5. publications.aap.org publications.aap.org/neoreviews/article/22/2/e104/92276/Gastroesophageal-Reflux-Disease-in-Neonates-Facts

Gastroesophageal Reflux Disease in Neonates: Facts and ... In healthy preterm infants, an average of 2 to 3 reflux events occur per hour, as has been reported using 24-hour pH impedance monitoring.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06118697

Feasibility of Aerodigestive Stimulation Therapy Trial | ... Participants will have weekly pharyngo-esophageal stimulation guided by High Resolution Impedance Manometry (HRIM) for 4 weeks or until discharge, oral ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4104136/

Neuro-motor mechanisms of Pharyngo-esophageal Motility ... Alternatively, feeding difficulties may follow underlying central neurological sequelae or immature brain development (14,15). Regardless of the etio- ...

8. mdpi.com mdpi.com/2227-9067/8/12/1158

Feeding Problems and Long-Term Outcomes in Preterm ... This review provides an overview of the physiology of swallowing and oral feeding skills, disruptions to oral feeding in preterm infants, the outcomes of ...