Study of Fetal Swallowing
Pilot Study: Ultrasonic Evaluation of the Development of the Fetal Upper Aerodigestive Tract: Establishing Clinical Indicators of Deglutitive Function
2 other identifiers
observational
120
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2000
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2000
CompletedFirst Submitted
Initial submission to the registry
February 11, 2000
CompletedFirst Posted
Study publicly available on registry
February 14, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2004
CompletedMarch 4, 2008
May 1, 2004
February 11, 2000
March 3, 2008
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- Only mothers with singleton or twin pregnancies will be included in the pilot study.
- All parents will sign both the NIH and teh NNMC/Georgetown consent forms at the beginning of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Warren G. Magnuson Clinical Center (CC)
Bethesda, Maryland, 20892, United States
Related Publications (3)
Abramowicz JS, Sherer DM, Bar-Tov E, Woods JR Jr. The cheek-to-cheek diameter in the ultrasonographic assessment of fetal growth. Am J Obstet Gynecol. 1991 Oct;165(4 Pt 1):846-52. doi: 10.1016/0002-9378(91)90427-s.
PMID: 1951542BACKGROUNDAchiron R, Ben Arie A, Gabbay U, Mashiach S, Rotstein Z, Lipitz S. Development of the fetal tongue between 14 and 26 weeks of gestation: in utero ultrasonographic measurements. Ultrasound Obstet Gynecol. 1997 Jan;9(1):39-41. doi: 10.1046/j.1469-0705.1997.09010039.x.
PMID: 9060129BACKGROUNDBowie JD, Clair MR. Fetal swallowing and regurgitation: observation of normal and abnormal activity. Radiology. 1982 Sep;144(4):877-8. doi: 10.1148/radiology.144.4.7111741. No abstract available.
PMID: 7111741BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Sponsor Type
- NIH
Study Record Dates
First Submitted
February 11, 2000
First Posted
February 14, 2000
Study Start
February 1, 2000
Study Completion
May 1, 2004
Last Updated
March 4, 2008
Record last verified: 2004-05