Studying Fetal Breathing Patterns

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00066976
First received: August 7, 2003
Last updated: March 7, 2008
Last verified: March 2008
  Purpose

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
Pregnancy

Study Type: Observational
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

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 0
Study Start Date: August 2003
Estimated Study Completion Date: March 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00066976

Locations
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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00066976     History of Changes
Other Study ID Numbers: 030258, 03-CH-0258
Study First Received: August 7, 2003
Last Updated: March 7, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Prenatal
Respiration
Ultrasound
Prematurity
Diagnoses
Fetal Breathing-Movement
Doppler Sonography
Amniotic Fluid
Oligohydraminos
Polyhydraminos
Pregnancy

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 25, 2014