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Studying Fetal Breathing Patterns

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00066976
Recruitment Status : Completed
First Posted : August 8, 2003
Last Update Posted : July 2, 2017
Information provided by:
National Institutes of Health Clinical Center (CC)

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.

Condition or disease

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 16.0 to 39.6 weeks' gestational age and cases with polyhydramnios/oligohydramnios. 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.

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Study Type : Observational
Enrollment : 0 participants
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
Study Start Date : August 5, 2003
Study Completion Date : March 3, 2008

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Both normal controls and test cases will be openly recruited from referrals to the NNMC PAC.

Healthy mother's 18 years of age and over with uneventful, singleton pregnancies dated at 16.0 to 39.6 weeks gestation (based on last menstrual period) are the inclusion criteria.


Mothers with pregnancies outside this dating and under 18 years of age are an exclusion factor.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00066976

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United States, California
Naval Medical Center, San Diego
San Diego, California, United States, 92134-5000
United States, Maryland
National Naval Medical Center
Bethesda, Maryland, United States, 20889
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Layout table for additonal information Identifier: NCT00066976    
Other Study ID Numbers: 030258
First Posted: August 8, 2003    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: March 3, 2008
Keywords provided by National Institutes of Health Clinical Center (CC):
Fetal Breathing-Movement
Doppler Sonography
Amniotic Fluid
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes