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PregnancyNCT00066976

Studying Fetal Breathing Patterns

An observational study of Pregnancy, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pregnancy
How many people
0 participants
Where
2 sitesUnited States
Study dates
5 Aug 2003to 3 Mar 2008
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • National Naval Medical Center

    Bethesda, Maryland, 20889

  • Naval Medical Center, San Diego

    San Diego, California, 92134-5000

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Pregnancy
Keywords
Prenatal, Respiration, Ultrasound, Prematurity, Diagnoses, Fetal Breathing-Movement, Doppler Sonography, Amniotic Fluid, Oligohydraminos, Polyhydraminos, Pregnancy
Medical subject headings
Respiratory Aspiration, Premature Birth, Disease

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2003 (estimated)
  2. Study start5 Aug 2003
  3. Study completion3 Mar 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Enrolment
0 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00066976
Sponsor's protocol ID
030258
Other IDs
03-CH-0258
Status last verified
3 Mar 2008
First submitted
7 Aug 2003
Last updated
2 Jul 2017
Results posted
No

Publications

  • 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.

    PubMed 7604911

Questions about this trial

What is this clinical trial studying?

An observational study of Pregnancy, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00066976, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.

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