Novel PIONEER© Protocol: RCT
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-6
SponsorNationwide Children's Hospital
About this trial
Neonatal ICU survivors often face challenges with oral eating, swallowing difficulties, and various aerodigestive issues, and commonly need chronic nasogastric tube feeding or gastrostomy feeding, which escalates socioeconomic burdens, hospital stays, neurodevelopmental delays, and parental suffering. This proposal addresses a vital need in neonatal gastroenterology by studying unique swallowing mechanisms and defining the basis for preventative and corrective therapies through new translational research initiatives via a randomized controlled trial using the novel intervention initiative- Parent Implemented Oral Nutrition, Eating, and Esophageal reflexes Reintegration (PIONEER©) protocol.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Nasogastric tube fed infants referred for diagnostic manometry and Gastrostomy tube planning evaluations.
Physiologically stable convalescing infants on full enteral feeds at greater than or equal to 37.0 weeks and less than 46 weeks postmenstrual age.
Presence of aerodigestive reflexes on diagnostic manometry.
Disqualifiers
Potentially lethal congenital or chromosomal anomalies
Craniofacial defects (cleft lip or palate)
History of GI surgery, ENT surgery, or neurosurgery
Need for supplemental respiratory support of >2 LPM
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
134 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
Presence or Absence of Gastrostomy Tube
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.
Time frame
around 4 weeks after initial diagnostic study or until discharge (can be sooner)2
Change in Aerodigestive Reflexes
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.
Time frame
around 4 weeks after initial diagnostic studySecondary outcomes
1
Parent reported stress and comfort level
Parent questionnaire
Time frame
up to 1 year2
Length of Hospital Stay
Length of Hospitalization from birth to discharge.
Time frame
at discharge3
Growth Metrics
Weight, Length and Head Circumference measurements until 1 year corrected age.
Time frame
until 1 year corrected age4
Neurodevelopment
Bayley scores obtained from electronic medical records.
Time frame
1-2 yearsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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