Parent Implemented Oral Nutrition, Eating, and Esophageal Reflexes Reintegration Protocol: RCT
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-6
SponsorNationwide Children's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Potentially lethal congenital or chromosomal anomalies
Severe Neuropathology
Craniofacial defects (cleft lip or palate)
History of GI surgery, ENT surgery, or neurosurgery
Trial design
Design model
Parallel
Treatments tested in this trial
PIONEER Protocol
Combination product* 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
Treatment groups
130 Participants
are divided into 2 treatment groupsGroup A: Intervention Group: PIONEER ProtocolExperimental treatment 1 intervention
Group B: Control Group: Standard of care treatmentNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Improvement in oral feeding and absence of gastrostomy tube
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
Time frame
improvement in feeding from prior to initial study to 4 weeks or discharge if sooner, gastrostomy tube at discharge2
Compare the change in mechanistic biomarkers between the groups
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.
Time frame
after 4 weeks or prior to discharge if soonerSecondary outcomes
1
Change in feeding volume at discharge
will measure the % of oral feeds prior to initial study and at discharge
Time frame
at discharge2
Length of hospital stay (LOHS) and postmenstrual age (PMA) at discharge
Compare the LOHS and PMA at discharge between the control and the intervention group.
Time frame
at discharge3
Growth
Compare weight, length and head circumference growth between groups until 1 year corrected age between the control and the intervention group.
Time frame
until 1 year corrected age4
Neurodevelopment
compare available Bayley scores obtained from electronic medical records between the control and the intervention group .
Time frame
at 18-26 months corrected ageLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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