Parent-Implemented Oral Nutrition, Eating, and Esophageal Reflexes Reintegration Program Using Novel Aerodigestive Stimulation in Gastrostomy Risk Infants: RCT on Clinical and Mechanistic Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 130
- 主要终点
- Improvement in oral feeding and absence of gastrostomy tube
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Week 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Nasogastric tube fed infants on full enteral feeds
- •≥37 and ≤46 weeks postmenstrual age at initial study
- •Presence of aerodigestive reflexes on initial pharyngoesophageal manometry.
排除标准
- •Potentially lethal congenital or chromosomal anomalies
- •Severe Neuropathology
- •Craniofacial defects (cleft lip or palate)
- •History of GI surgery, ENT surgery, or neurosurgery
- •Need for supplemental respiratory support of >2 LPM
研究组 & 干预措施
Control Group: Standard of care treatment
Standard feeding management per primary care team:
-Cue based po feeds per the unit protocol
Intervention Group: PIONEER Protocol
PIONEER Protocol
- Nutritive oral stim with each feed (at least 5mL)
- Esophageal stimulation at least 3 times per week
- Weekly high resolution pharyngoesophageal manometry with esophageal stimulation
- Parent biofeedback/oral feeding participation
干预措施: PIONEER Protocol (Combination Product)
结局指标
主要结局
Improvement in oral feeding and absence of gastrostomy tube
时间窗: 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
时间窗: 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.
Presence or Absence of Gastrostomy Tube
时间窗: around 4 weeks after initial diagnostic study or until discharge (can be sooner)
Primary outcome is successful oral feeding without G-tube measured at the Primary Endpoint of discharge. This determination allows us to test the effect of interventions during a 4 week-period, continued residual effects after 4 weeks, and parental comfort with the collaborative decision of feeding method at discharge.
Change in Aerodigestive Reflexes
时间窗: around 4 weeks after initial diagnostic study
Primary outcome is the change in the recruitment of sensory-motor characteristics, and magnitude of aerodigestive reflexes at rest and upon stimulation that are assessed at the repeat manometry study at \~4 weeks, and compared among and between the two arms, testing the effects of intervention protocol.
次要结局
- Change in feeding volume at discharge(at discharge)
- Length of hospital stay (LOHS) and postmenstrual age (PMA) at discharge(at discharge)
- Growth(until 1 year corrected age)
- Neurodevelopment(at 18-26 months corrected age)
- Pulmonary support at discharge(at discharge)
- Parent satisfaction and stress level(at 4 weeks or discharge, whichever is sooner)
- Compare the change in mechanistic biomarkers within the groups(At four weeks or discharge whichever is sooner)
- Longterm Feeding Outcomes(until 1 year corrected age)
- Length of Hospital Stay(at discharge)
- Growth Metrics(until 1 year corrected age)
- Parent reported stress and comfort level(up to 1 year)
- Neurodevelopment(1-2 years)
研究者
Sudarshan Jadcherla
Physician - Neonatology Central Campus
Nationwide Children's Hospital