Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066976
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2003-08-07
Brief Title:
Studying Fetal Breathing Patterns
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Classification of Fetal Breathing Patterns in the Maturing Upper Airway Spectral Waveform Analysis of Amniotic Fluid Flow Dynamics in Normal Development Polyhydramnios and Oligohydramnios
Status:
COMPLETED
Status Verified Date:
2008-03-03
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:
Some babies have difficulty breathing sucking and swallowing at birth The purpose of this study is to determine before birth the variables that will predict whether a newborn will experience these problems
Study participants will be pregnant women with a single fetus who are 18 years or older and who are scheduled to receive a standard prenatal ultrasound Researchers will use the ultrasound to observe fetal motions associated with breathing sucking and swallowing on digital videotape They will then review these tapes and take measurements that will help them document how breathing and swallowing develop
Study participants will be pregnant women with a single fetus who are 18 years or older and who are scheduled to receive a standard prenatal ultrasound Researchers will use the ultrasound to observe fetal motions associated with breathing sucking and swallowing on digital videotape They will then review these tapes and take measurements that will help them document how breathing and swallowing develop
Detailed Description:
The aerodigestive tract is a complex system of integrated anatomical structures supporting ingestive and respiratory functions The developmental origins of this system begin in utero where the prenatal growth of morphologic structures and their associated emerging behaviors form key physiologic foundations necessary to sustain life at birth The quality of aerodigestive development is thus inextricably related to both the structural integrity of its growing anatomy and the emergence of processes that promote aerodigestive functioning Our past research NIH CC-00-99 NNMC B99-089 focused specifically on emerging oropharyngeal and laryngeal movements of neonatal swallowing and phonation Through innovative sonographic techniques this work documented ingestive development in the living fetus however respiratory aspects were not explored Intuitively disruptions to the fetal-maternal environment also influence respiratory development and thus an arrest disorder or delay in maturation of upper airway mechanisms may directly affect subsequent postnatal respiratory function Thus the purposes of this protocol are to 1 continue exploration of human fetal development by elucidating the association between upper airway growth and emerging prenatal respiratory function and 2 determine identifiable patterns of normal respiratory maturation that may provide indicators of postnatal airway performance
This initiative is based on the premise that amniotic fluid volumes are influenced by the integrity of upper airway mechanisms and thus are important for aerodigestive-related development and fetal well being In a collaborative effort with National Naval Medical Center this project will use a novel standardized 4-axis sonographic examination to quantify growth and respiratory-related fluid flow mechanics in the upper airway of the living human fetus The use of this noninvasive ultrasound technique as part of the clinical prenatal examination will not only discriminate function at four upper airway sites perinasal oral pharyngeal and tracheal but provide estimates of amniotic fluid flow volumes inspiratory-expiratory fluid flow velocities and durations and Doppler waveform patterns associated with fetal breathing and ingestive processes This provides a method from which we can begin to explore how deviations in amniotic fluid regulation may be associated with morbidity and mortality and the predictive utility of these indices in understanding conditions such as oligohydramnios or polyhydramnios This germinal database will include healthy fetuses 160 to 396 weeks gestational age and cases with polyhydramniosoligohydramnios By elucidating how developing structures integrate with emerging upper respiratory behaviors this work will document the maturational events underlying normal function at birth that in turn may facilitate future clinical strategies for successful postnatal care
This initiative is based on the premise that amniotic fluid volumes are influenced by the integrity of upper airway mechanisms and thus are important for aerodigestive-related development and fetal well being In a collaborative effort with National Naval Medical Center this project will use a novel standardized 4-axis sonographic examination to quantify growth and respiratory-related fluid flow mechanics in the upper airway of the living human fetus The use of this noninvasive ultrasound technique as part of the clinical prenatal examination will not only discriminate function at four upper airway sites perinasal oral pharyngeal and tracheal but provide estimates of amniotic fluid flow volumes inspiratory-expiratory fluid flow velocities and durations and Doppler waveform patterns associated with fetal breathing and ingestive processes This provides a method from which we can begin to explore how deviations in amniotic fluid regulation may be associated with morbidity and mortality and the predictive utility of these indices in understanding conditions such as oligohydramnios or polyhydramnios This germinal database will include healthy fetuses 160 to 396 weeks gestational age and cases with polyhydramniosoligohydramnios By elucidating how developing structures integrate with emerging upper respiratory behaviors this work will document the maturational events underlying normal function at birth that in turn may facilitate future clinical strategies for successful postnatal care
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 |
|---|---|---|---|
| 03-CH-0258 | None | None | None |