Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004566
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-02-11
Brief Title:
Study of Fetal Swallowing
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Pilot Study Ultrasonic Evaluation of the Development of the Fetal Upper Aerodigestive Tract Establishing Clinical Indicators of Deglutitive Function
Status:
COMPLETED
Status Verified Date:
2004-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 babys 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 DC 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 babys feeding skills Follow-up visits at 4 and 8 weeks after the birth will include observation of the babys sucking and swallowing and an ultrasound examination in which the transducer is held under the babys 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 babys sucking and swallowing and an ultrasound examination in which the transducer is held under the babys chin during swallowing
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 DC 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 babys feeding skills Follow-up visits at 4 and 8 weeks after the birth will include observation of the babys sucking and swallowing and an ultrasound examination in which the transducer is held under the babys 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 babys sucking and swallowing and an ultrasound examination in which the transducer is held under the babys chin during swallowing
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-CC-0081 | None | None | None |