CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 56 enrolled
Drug / intervention
Decision Support Toolbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04850794
NCT04850794N/ACompleted

Evaluation of an Interdisciplinary Decision Guide for Infant Feeding Assessment

University of North Carolina, Chapel Hill·interventional·Posted Apr 20, 2021·Updated Mar 21, 2023

In Brief

A clinical study evaluating Decision Support Tool for Premature Birth and Feeding and Eating Disorders of Childhood. Completed, enrolled 56 participants across 1 site.

Detailed Summary

Preterm infants are at risk for feeding problems which can persist through early childhood. These feeding problems may include oral motor, sensory, digestive, nutritional, respiratory, and/or behavioral components. In North Carolina's early intervention program, speech pathologists or occupational therapists are responsible for completing feeding evaluations, and may not know when to refer infants out to medical specialists to address these other domains. This study will test a decision support tool in hypothetical feeding evaluation scenarios. The hypothetical scenarios will consist of real feeding videos of preterm infants who recently participated in a multidisciplinary feeding evaluation. Parent-reported outcomes of the infant's real evaluation will be compared to those of the speech pathologists and occupational therapists in our study who do, and do not, use the decision support tool. The investigators hypothesize that therapists with the tool will make recommendations that are closer to those of the multidisciplinary team, and that they will find the tool useful and easy to use. Due to recruitment limitations with families, the study was adapted in October, 2021 prior to enrollment of subjects to use case studies, rather than infant videos, as the hypothetical situation from which to test the tool. Therapists will then answer clinical questions without using the tool when viewing the first case study, and will use the tool to answer questions when viewing the second case study. Order of case study presentation will be randomized among participants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20222023202420252026
First PostedApr 20, 2021
Enrollment StartJul 14, 2021
Primary CompletionFeb 7, 2022
Study CompletionFeb 8, 2022
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 5.2 years ago

Interventions

Decision Support Toolbehavioral

The decision support tool is an observational checklist with recommendations for specific specialist referrals based on what the provider observed during the feeding evaluation.