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Neonatal Respiratory FunctionNCT02475811

3D Ultrasonography Fetal Lung Volume Measurement and Neonatal Respiratory Function

An observational study of Neonatal Respiratory Function, run by Cairo University at 1 site in Egypt.

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

One hundred healthy women with singleton pregnancies in the 1st stage of labor will be included in the study, divided into two groups; Group A (n: 50 - women pregnant ± 34-37 weeks) \& Group B (n: 50 - women pregnant ± 37+1-40 weeks). Read more about this study

Who is it for?
Ages 18 to 40 years, women only
Conditions the study is for
Neonatal Respiratory Function
What is being tested?
3D ultrasonography
Type of treatment
Surgery or procedure
How many people
100 participants
Where
1 siteEgypt
Study dates
Jun 2015to Jan 2017
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 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: One hundred healthy women with singleton pregnancies presented in the 1st stage of labour

Who may be able to join

  • One hundred healthy women with singleton pregnancies presented in the 1st stage of labour were included in the study. Participants were divided into two groups; Group A (n: 50 - women pregnant ± 34-37 weeks gestation) \& Group B (n: 50 - women pregnant ± 37+1-40 weeks gestation). Gestational age (GA) is established by menstrual dates then confirmed by obstetric ultrasound

Who cannot join

  • Exclusion criteria include the maternal administration of respiratory depressants within 2 hours from the delivery of the fetus (e. g., opioid analgesic \& general anesthesia upon doing CS) or oligohydramnios (amniotic fluid index < 5th centile), rupture of membranes, the presence of fetal malformations (chest, heart or abdominal) or abnormal fetal growth (defined as: estimated fetal weight < 5th centile or > 95th centile and/or abdominal circumference < 5th centile or > 95th centile). Also, women with a cardiac pacemaker were excluded (as the transmitter necessary for the lung volume measurements could disturb the function of the pacemaker).

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Kasr Alainy medical school

    Cairo, Cairo Governorate, 12151

Other trials in Egypt

About this study

Official title: The Role of 3D Ultrasonography Fetal Lung Volume Measurement in the Prediction of Neonatal Respiratory Function Outcome

One hundred healthy women with singleton pregnancies in the 1st stage of labor will be included in the study, divided into two groups; Group A (n: 50 - women pregnant ± 34-37 weeks) \& Group B (n: 50 - women pregnant ± 37+1-40 weeks). A 3D volume model of the right fetal lung is generated \& lung volume is calculated using VOCAL software. After child birth, neonatal respiratory functions will be assessed using APGAR score at (1, 5 and 10 min) together with occurrence of RDS and the further need for NICU admission and respiratory support measurements.

Read the detailed description

One hundred healthy women with singleton pregnancies presented in the 1st stage of labour will beincluded in the study. Participants will be divided into two groups; Group A (n: 50 - women pregnant ± 34-37 weeks gestation) \& Group B (n: 50 - women pregnant ± 37+1-40 weeks gestation). Gestational age (GA) is established by menstrual dates then confirmed by obstetric ultrasound.

For both groups, full history will be taken including the receiving of antenatal steroids followed by general, abdominal \& pelvic examination to confirm the stage of labour \& to exclude the presence of rupture of membranes. Obstetric ultrasound will be done to confirm GA, assess amniotic fluid index (AFI) \& to exclude fetal anomalies. Fetal lung volume (FLV) measured using Voluson 730 Expert ultrasonography machine (GE Healthcare Austria GmbH, Seoul, Korea) equipped with a 4- to 8- MHz transabdominal transducer for 3-dimensional (3D) volume scanning. A single examiner will perform all ultrasound examinations with the following technique; a transverse section of the fetal thorax at the level of the 4-chamber view, with the fetal heart proximal to the transducer, was identified by 2-dimensional ultrasonography, and the volume box will be adjusted to scan the entire fetal thorax. The maximum resolution will be adjusted. The angle of volume sampling varied throughout gestational age with a maximum limit of 75° in the third trimester. After scanning the volume, multiplanar imaging in the 3 orthogonal ultrasonographic sections will be analyzed to reconstruct the 3D ultrasound image. Before its volume was analyzed, each lung was carefully identified on the 3 orthogonal multiplanar imaging sections. The investigators will use the rotational technique that entails the VOCAL imaging program to measure lung volume. A transverse section of the multiplanar imaging will be chosen as the reference image for volume analyses (Figure 1). Right lung volume will be measured by a series of area tracing of the studied lung after serial rotations of 30° (6 times; Figures 2 and 3). Reviewing parallel slices executed through the whole lung in the 3 perpendicular planes allowed us to check the adequacy of our rotational area tracing approach. Right lung volume was automatically measured and plotted against gestational age, taking about 2 minutes to estimate the lung volume. After child birth, neonatal respiratory functions will be assessed using APGAR score at (1, 5 and 10 min) together with occurrence of RDS and the further need for neonatal ICU admission and respiratory support measurements.

Being tested
3D ultrasonography
Keywords
3D ultrasonography, fetal Lung Volume, neonatal respiratory function

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3D ultrasonographyRadiation

    The angle of volume sampling varied throughout gestational age with a maximum limit of 75° in the third trimester. After scanning the volume, multiplanar imaging in the 3 orthogonal ultrasonographic sections was analyzed to reconstruct the 3D ultrasound image. Before its volume was analyzed, each lung was carefully identified on the 3 orthogonal multiplanar imaging sections. We used the rotational technique that entails the VOCAL imaging program to measure lung volume. A transverse section of the multiplanar imaging was chosen as the reference image for volume analyses

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Apgar score

    Measured: 1 minute after delivery

Secondary outcomes (2)
  1. Neonatal ICU admission

    Measured: 24 hour after delivery

  2. Apgar score

    Measured: 5 minutes after delivery

Timeline

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

  1. First posted19 Jun 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionDec 2016
  4. Study completionJan 2017

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02475811
Sponsor's protocol ID
137
Status last verified
Mar 2017
First submitted
15 Jun 2015
Last updated
24 Mar 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Neonatal Respiratory Function, run by Cairo University at 1 site in Egypt.

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 1 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 24 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. 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.

What does the primary outcome measure?

Apgar score (time frame: 1 minute after delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 24 Mar 2017.

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