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Quantitative Assessment of Sucking for Early Diagnosis of Brain Injury in Infants at High Risk

NCT03246243 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 16

Last updated 2021-05-21

No results posted yet for this study

Summary

The main goal of this study is to quantitatively assess the sucking and feeding activity of infants at high risk of neurological impairment (preterm infants and term infants at risk of abnormal neurodevelopment) during oral sucking and feeding and correlate it with their underlying neurological impairment for the early diagnosis of brain injury.

Conditions

  • Hypoxic-Ischemic Encephalopathy
  • Hypoglycemia
  • Neonatal Abstinence Syndrome

Interventions

DEVICE

nfant feeding solution

The study will record the sucking activity of the hospitalized infants over time, from their first oral sucking session including non-nutritive and nutritive sucking, until discharge, using an FDA-approved device that equips a typical bottle and nipple commonly used in the NICU with a non-invasive sensor to measure sucking activity. Each infant's nutritive and non-nutritive sucking patterns will be measured, and will comprise the 'sucking session' conducted with the bottle sensor.

Sponsors & Collaborators

Principal Investigators

  • Christos Papadelis, PhD · Boston Children's Hospital

Eligibility

Max Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-29
Primary Completion
2021-05-18
Completion
2021-05-18

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03246243 on ClinicalTrials.gov