Studying Fetal Breathing Patterns
Primary Purpose
Pregnancy
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Pregnancy focused on measuring Prenatal, Respiration, Ultrasound, Prematurity, Diagnoses, Fetal Breathing-Movement, Doppler Sonography, Amniotic Fluid, Oligohydraminos, Polyhydraminos, Pregnancy
Eligibility 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.
Sites / Locations
- Naval Medical Center, San Diego
- National Naval Medical Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00066976
First Posted
August 7, 2003
Last Updated
June 30, 2017
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT00066976
Brief Title
Studying Fetal Breathing Patterns
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 Type
Observational
2. Study Status
Record Verification Date
March 3, 2008
Overall Recruitment Status
Completed
Study Start Date
August 5, 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 3, 2008 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy
Keywords
Prenatal, Respiration, Ultrasound, Prematurity, Diagnoses, Fetal Breathing-Movement, Doppler Sonography, Amniotic Fluid, Oligohydraminos, Polyhydraminos, Pregnancy
7. Study Design
Enrollment
0 (false)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Naval Medical Center, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92134-5000
Country
United States
Facility Name
National Naval Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
7604911
Citation
Kliegman RM. Neonatal technology, perinatal survival, social consequences, and the perinatal paradox. Am J Public Health. 1995 Jul;85(7):909-13. doi: 10.2105/ajph.85.7.909.
Results Reference
background
Learn more about this trial
Studying Fetal Breathing Patterns
We'll reach out to this number within 24 hrs