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.
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.
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.
- Conditions
- Neonatal Respiratory Function
- 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.
Apgar score
Measured: 1 minute after delivery
Secondary outcomes (2)
Neonatal ICU admission
Measured: 24 hour after delivery
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.
- First posted19 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Respiratory FunctionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maged, Cairo University
- Investigators
- Ahmed Maged, Principal investigator, Kasr Alainy medical school
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of 3D Ultrasonography Fetal Lung Volume Measurement in the Prediction of Neonatal Respiratory Function Outcome
- ClinicalTrials.gov ID
- NCT02475811
- Acronym / sponsor ID
- 137
- Conditions
- Neonatal Respiratory Function
- Keywords
- 3D ultrasonography, fetal Lung Volume, neonatal respiratory function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 19 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- One hundred healthy women with singleton pregnancies presented in the 1st stage of labour
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D ultrasonographyThe 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 | Radiation | – |
Primary outcome
Apgar score
Time frame: 1 minute after delivery
2 secondary outcomes
Neonatal ICU admission
Time frame: 24 hour after delivery
Apgar score
Time frame: 5 minutes after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Maged principal investigator
Kasr Alainy medical school
1 site in 1 country: see every site and its status.
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.