Chronic Tube Feeding in Hospitalized Infants, Deglutition Disorders in Infants
Conditions
Keywords
Neonatal, Deglutition Disorders, NICU infants, Gastrostomy prevention, Chronic tube feeding
Brief summary
Feeding dysfunction remains a major unmet challenge among neonatal ICU survivors, frequently leading to prolonged tube feeding or gastrostomy at discharge, increased healthcare utilization, substantial socioeconomic burden, and adverse neurodevelopmental outcomes. This randomized controlled trial will evaluate the innovative Parent-Implemented Oral Nutrition, Eating, and Esophageal Reflexes Reintegration (PIONEER) protocol to advance understanding of swallowing physiology and establish a safe, effective, family-centered feeding intervention. Successful completion of this study has the potential to reduce gastrostomy dependence, improve long-term health and quality of life, and transform standards of neonatal feeding care in alignment with NIH missions and priorities.
Detailed description
Survival of neonatal intensive care unit (NICU) infants has improved substantially; however, chronic tube feeding, aerodigestive, and neurodevelopmental morbidities continue to rise. Disorders of Deglutition, characterized by impaired feeding and swallowing function, contribute to poor nutrition, impaired growth, prolonged hospitalization, adverse neurodevelopmental outcomes, and increased reliance on gastrostomy tube (G-tube) feeding. Effective, evidence-based interventions that promote oral feeding competence during critical develop-mental periods are urgently needed to reduce chronic tube feeding and its associated health and socioeconomic burdens. The long-term goal of this research is to improve feeding, aerodigestive and developmental outcomes in high-risk NICU infants through biologically informed interventions. The objective of this application is to determine the efficacy and mechanisms of the Parent-Implemented Oral Nutrition, Eating, and Esophageal Reflexes Reintegration (PIONEER) protocol using feeding and aerodigestive stimulation therapy for infants at risk for G-tube placement. Safety, feasibility, and preliminary efficacy of the intervention have been established. The central hypothesis is that targeted stimulation of aerodigestive reflex pathways during critical develop-mental windows promotes adaptive maturation of feeding-related neural and sensorimotor networks, resulting in improved aerodigestive reflex function, enhanced oral feeding competence, and reduced G-tube need. This hypothesis will be tested in a randomized controlled trial comparing the PIONEER protocol with standard care. Aim 1: Determine the efficacy of PIONEER Protocol in improving oral feeding outcomes and reducing G-tube placement. Primary outcome will be met with improvement in oral feeding by 4 weeks and avoidance of G-tube at discharge. We hypothesize that more infants randomized to the PIONEER protocol will have improvement in oral intakes and avoidance of G-tubes at discharge versus infants receiving standard care. Aim 2: Define the mechanistic biomarkers associated with intervention response. We will test the hypothesis that the PIONEER protocol enhances sensory-motor integration and normalizes aerodigestive reflex function compared with standard care. We will perform longitudinal HRPEM studies to identify treatment-related changes in physiological biomarkers and determine the mechanistic basis of improved feeding outcomes. Primary outcome: change in HRPEM-derived aerodigestive biomarkers from baseline to final study assessment. The expected outcomes and impact of this project are: (1) validation of an effective parent-implemented intervention for infants at risk for chronic tube feeding; (2) identification of mechanistic biomarkers linking physio-logical adaptations to clinically meaningful feeding outcomes; and (3) establishment of a scalable, evidence-based therapy to improve feeding safety, feeding efficiency, growth, and developmental outcomes. Successful completion of this project is expected to reduce G-tube dependence, shorten NICU hospitalization, improve quality of life for infants and families, and lessen the substantial public health burden associated with feeding disorders.
Interventions
COMBINATION_PRODUCTPIONEER Protocol
* Oral nutritive stimulus with every feed (minimum 5mL) * Esophageal stimulation with up to 15 stimulations given at least 5 times per week with stimulation catheter * High resolution esophageal manometry as much as weekly if feasible throughout protocol * Parent biofeedback (during manometry studies) and education on at least a weekly basis with focus on their participation in oral feeding
Sponsors
Nationwide Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Qualifying consented subjects will be randomized to standard feeding management with cue based feeds (Control) or the PIONEER protocol (Intervention).
Eligibility
Sex/Gender
ALL
Age
1 Weeks to 6 Months
Healthy volunteers
No
Inclusion criteria
1. Nasogastric tube fed infants on full enteral feeds 2. ≥37 and ≤46 weeks postmenstrual age at initial study 3. Presence of aerodigestive reflexes on initial pharyngoesophageal manometry.
Exclusion criteria
1. Potentially lethal congenital or chromosomal anomalies 2. Severe Neuropathology 3. Craniofacial defects (cleft lip or palate) 4. History of GI surgery, ENT surgery, or neurosurgery 5. Need for supplemental respiratory support of \>2 LPM
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in oral feeding and absence of gastrostomy tube | improvement in feeding from prior to initial study to 4 weeks or discharge if sooner, gastrostomy tube at discharge | Will compare successful outcomes of improvement in oral feeding at 4 weeks and absence of gastrostomy at discharge between the control and the intervention group |
| Compare the change in mechanistic biomarkers between the groups | after 4 weeks or prior to discharge if sooner | Will measure the difference in longitudinal change in aerodigestive biomarkers from initial to final HRPEM between the groups from the initial to the final high resolution pharyngoesophageal manometry. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in feeding volume at discharge | at discharge | will measure the % of oral feeds prior to initial study and at discharge |
| Length of hospital stay (LOHS) and postmenstrual age (PMA) at discharge | at discharge | Compare the LOHS and PMA at discharge between the control and the intervention group. |
| Growth | until 1 year corrected age | Compare weight, length and head circumference growth between groups until 1 year corrected age between the control and the intervention group. |
| Neurodevelopment | at 18-26 months corrected age | compare available Bayley scores obtained from electronic medical records between the control and the intervention group . |
| Longterm Feeding Outcomes | until 1 year corrected age | Compare feeding method during the first year of life between the control and the intervention group. |
| Pulmonary support at discharge | at discharge | Compare the respiratory support at discharge between the control and the intervention group |
| Parent satisfaction and stress level | at 4 weeks or discharge, whichever is sooner | Will compare parent surveys done prior to initial study and after final study between the control and the intervention group |
| Compare the change in mechanistic biomarkers within the groups | At four weeks or discharge whichever is sooner | To compare the longitudinal change in esophageal and sphincteric length and region-specific contractile and relaxation integrals (mmHg.cm.sec) amongst feeding success and failure within and between groups. |
Contacts
CONTACTErika K Osborn
CONTACTPatty Luzader
PRINCIPAL_INVESTIGATORSudarshan Jadcherla
Nationwide Children's Hospital
Outcome results
None listed