Completed

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

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What is being collected

Data Collection

Who is being recruted

Digestive System Diseases+3

+ Esophageal Diseases

+ Gastrointestinal Diseases

See all eligibility criteria
How is the trial designed

Observational
Study Start: February 2000
See protocol details

Summary

Principal SponsorNational Institutes of Health Clinical Center (CC)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2000

Actual date on which the first participant was enrolled.

The normal term infant at birth is able to suck-swallow in a coordinated manner sufficient for nutritional intake and protection of the upper airway. The integrity of this post-natal behavior is dependent on intrauterine growth and function of the orofacial, pharyngeal and laryngeal structures of the upper aerodigestive system. The integrity of these structures not only ensures functional postnatal ingestive skills, but also contributes to the prenatal development of the gastrointestinal tract, regulation of amniotic fluid and composition, and recirculation of solutes. This developing system thus has importance in both fetal and neonatal well-being. However, few biometric or biophysical data exist detailing the normal patterns of growth and development of the aerodigestive structures in the human fetus. Further, factors that contribute to abnormal fetal and neonatal deglutitive responses are not fully known. The purpose of this study is to establish the first anthropomorphic database on the development of aerodigestive structures in the fetus and, through sonographic biophysical profiles, examine the significance of fetal ingestive behaviors as predictors of postnatal feeding skills in at-risk infants. A detailed cross-sectional study of the development of the fetal upper aerodigestive tract and analysis of the progression of deglutitive skills over the course of gestation may lead to the early identification of factors contributing to neonatal swallowing dysfunction and other developmental delays. These data may provide insights into underlying intrauterine conditions associated with infant feeding difficulties. Resulting two- and three-dimensional ultrasonic data on the structural development of the upper aerodigestive system, coupled with biophysical data may be useful predictors of neonates at risk for nutritional and pulmonary sequelae. Further, sequential indices of normal swallowing-sucking skills may guide post-natal decisions for feeding "readiness" and advance the care of the premature, at-risk infant.

NCT00004566
Principal SponsorNational Institutes of Health Clinical Center (CC)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesOtorhinolaryngologic DiseasesPharyngeal DiseasesDeglutition Disorders

Criteria

INCLUSION CRITERIA: 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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Warren G. Magnuson Clinical Center (CC)

Bethesda, United StatesOpen Warren G. Magnuson Clinical Center (CC) in Google Maps
CompletedOne Study Center