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N/ACompleted
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Search/NCT00004566
NCT00004566N/ACompleted

Pilot Study: Ultrasonic Evaluation of the Development of the Fetal Upper Aerodigestive Tract: Establishing Clinical Indicators of Deglutitive Function

National Institutes of Health Clinical Center (CC)·observational·Posted Feb 14, 2000·Updated Mar 4, 2008

In Brief

An observational study for Deglutition Disorder and High Risk Pregnancy. Completed, across 1 site.

Detailed Summary

This study will establish a database of fetal movements associated with feeding. It will use information obtained from standard fetal ultrasound procedures to identify and measure the growth of the baby's face, lips, tongue, jaw, throat and airway. Fetal movements involved in breathing, sucking and swallowing will be recorded on videotape. This study may provide information that will: increase knowledge about how swallowing develops in the fetus; help explain why some babies have difficulty sucking and swallowing at birth; help predict what babies are at increased risk for feeding problems; and help design better ways to manage feeding difficulties in babies. Pregnant women scheduled for ultrasound examination at the National Naval Medical Center in Bethesda, Maryland, or Georgetown University Hospital in Washington, D.C., are eligible for this study. Mothers will fill out a questionnaire providing general medical and health information. For the ultrasound procedure, a transducer (a small, wand-like device) is moved across the belly to produce images of the fetus. When the baby is awake and swallowing, images of the mouth, throat and air passages will be recorded on videotape. The movements associated with feeding-breathing, sucking, yawning and swallowing-will then be measured to document how swallowing develops. When the baby is born, researchers will review the medical chart for any findings relevant to this study. One to 2 weeks after delivery, the mother will be interviewed by telephone about the baby's feeding skills. Follow-up visits at 4 and 8 weeks after the birth will include observation of the baby's sucking and swallowing and an ultrasound examination, in which the transducer is held under the baby's chin during swallowing. Babies who show signs of slow sucking or swallowing development will have a follow-up examination at ages 4 and 8 months. Follow-up visits at 4 and 8 months after the birth will include observation of the baby's sucking and swallowing and an ultrasound examination, in which the transducer is held under the baby's chin during swallowing.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 14, 2000
Enrollment StartFeb 1, 2000
Study CompletionMay 1, 2004
TodayJul 2, 2026
Posted 26.4 years ago