Respiratory Distress Syndrome, NewbornNCT04107090
Role of Lung Ultrasound In Assessment Of Recruitment Maneuvers In Ventilated Preterms With Respiratory Distress Syndrome and Its Correlation With Tracheal IL-6 Level
A study testing lung recruitment maneuver, tracheal IL-6 level and US guided lung recruitment maneuver in people with Respiratory Distress Syndrome, Newborn, run by Ain Shams University at 1 site in Egypt.
Trial summary
This work is designed to: 1. Evaluate the efficacy of lung ultrasonography in detecting opening and closing lung pressures in ventilated preterm neonates with respiratory distress syndrome. 2. Read more about this study
- Who is it for?
- Ages 1 hour to 2 days
- Conditions the study is for
- Respiratory Distress Syndrome, Newborn
- What is being tested?
- lung recruitment maneuver, tracheal IL-6 level and US guided lung recruitment maneuver
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2018to 20 May 2019
- Phase
- Interventional
- 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 1 hour to 2 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age ≤ 36 weeks.
- In need for invasive mechanical ventilation for RDS according to Downes Score .
Who cannot join
- excluded:
- Major upper or lower airway anomalies.
- Significant congenital anomalies including cardiac, abdominal or respiratory.
- Surgical cases
- Inborn errors of metabolism
- Early onset sepsis.
- Meconium aspiration syndrome.
- Hypoxic ischemic encephalopathy.
Trial locations and contacts
1 site in 1 country.
About this study
This work is designed to:
- Evaluate the efficacy of lung ultrasonography in detecting opening and closing lung pressures in ventilated preterm neonates with respiratory distress syndrome.
- Determine the efficacy of lung ultrasonography in optimizing lung volume and its correlation with pulmonary inflammatory reaction as evidenced by IL-6 level in tracheal aspirate.
Read the detailed description
The studied population included 44 preterm infants. Anthropometric measurements, gestational age, sex, mode of delivery, maternal disease and Apgar score were found to be matched in the two studied groups indicating successful randomization as seen in these balanced demographic variables between the groups.
The studied population included 44 preterm infants. Then they were allocated randomly to one of 2 groups in order by admission:
Group A: included 22 patients on whom the recruitment maneuver was applied guided by lung ultrasonography.
Group B: included 22 patients on whom the recruitment maneuver was not ultrasound guided. This is considered the control group.
Anthropometric measurements, gestational age, sex, mode of delivery, maternal disease and Apgar score were found to be matched in the two studied groups indicating successful randomization as seen in these balanced demographic variables between the groups.
- Conditions
- Respiratory Distress Syndrome, Newborn
- Being tested
- lung recruitment maneuver, tracheal IL-6 level, US guided lung recruitment maneuver
- Medical subject headings
- Respiratory Distress Syndrome, Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung recruitment maneuverOther
Lung recruitment maneuver done for ventilated preterm neonates diagnosed with respiratory distress syndrome
tracheal IL-6 levelOther
tracheal IL-6 level was measured before and after recruitment maneuver
US guided lung recruitment maneuverOther
Lung recruitment maneuver done for ventilated preterm neonates diagnosed with respiratory distress syndrome guided by lung ultrasound
| Study group | Role | What they receive |
|---|---|---|
| US guided lung recruitment | Experimental | Group A: it included 22 patients on whom the recruitment manoeuvre was applied guided by lung ultrasonography. Receives: Other: lung recruitment maneuver; Other: tracheal IL-6 level; Other: US guided lung recruitment maneuver |
| Non US guided lung recruitment | Other | Group B: it included 22 patients on whom the recruitment maneuver was not ultrasound guided. This is considered the control group. Receives: Other: lung recruitment maneuver; Other: tracheal IL-6 level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung ultrasound and diagnosis of respiratory distress syndrome
Forty four preterm neonates diagnosed with respiratoey distress syndrome had lung ultrasound assessment . Its grading was N=normal (presence of lung sliding with A lines or fewer than two isolated B lines) , B1=multiple well-defined B lines , B2=multiple coalescent B lines , C=Consolidation.
Measured: 1 year
Lung ultrasound and recruitment maneuver
An ultrasound re aeration score is calculated from changes in the ultrasound pattern of each region examined during the recruitment maneuver (N,B1,B2,C).
Measured: 1 year
Lung ultrasound guided recruitment maneuver and the period of oxygen dependency.
The relation between early lung recruitment maneuver guided by lung ultrasound and how many days requiring oxygen therapy in the NICU .
Measured: 1 year
Lung ultrasound guided recruitment maneuver and the total number of NICU admission days.
The relation between early lung recruitment maneuver guided by lung ultrasound and how many days requiring admission in the NICU .
Measured: 1 year
Lung ultrasound guided recruitment maneuver and its relation to lung inflammation
Tracheal aspirate IL-6 is measured initially before recruitment maneuver, and on the third day if still ventilated ,or before extubation if done earlier than the third day.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start20 Jan 2018
- Primary completion1 Mar 2019
- Study completion20 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, NewbornStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was conducted on 44 preterm neonates who were mechanically ventilated for respiratory distress syndrome (RDS). Then they were allocated randomly to one of 2 groups in order by admission: Group A: it included 22 patients on whom the recruitment manoeuvre was applied guided by lung ultrasonography. Group B: it included 22 patients on whom the recruitment maneuver was not ultrasound guided. This is considered the control group.
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Reda Fikry Kamel, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107090
- Sponsor's protocol ID
- Lung Ultrasound
- Status last verified
- Sep 2019
- First submitted
- 19 Sep 2019
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Lung Ultrasound In Assessment Of Recruitment Maneuvers In Ventilated Preterms With Respiratory Distress Syndrome and Its Correlation With Tracheal IL-6 Level
- ClinicalTrials.gov ID
- NCT04107090
- Acronym / sponsor ID
- Lung Ultrasound
- Conditions
- Respiratory Distress Syndrome, Newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Jan 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 20 May 2019 (actual)
- First posted
- 27 Sep 2019 (actual)
- 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.
This work is designed to:
- Evaluate the efficacy of lung ultrasonography in detecting opening and closing lung pressures in ventilated preterm neonates with respiratory distress syndrome.
- Determine the efficacy of lung ultrasonography in optimizing lung volume and its correlation with pulmonary inflammatory reaction as evidenced by IL-6 level in tracheal aspirate.
Detailed description
The studied population included 44 preterm infants. Anthropometric measurements, gestational age, sex, mode of delivery, maternal disease and Apgar score were found to be matched in the two studied groups indicating successful randomization as seen in these balanced demographic variables between the groups.
The studied population included 44 preterm infants. Then they were allocated randomly to one of 2 groups in order by admission:
Group A: included 22 patients on whom the recruitment maneuver was applied guided by lung ultrasonography.
Group B: included 22 patients on whom the recruitment maneuver was not ultrasound guided. This is considered the control group.
Anthropometric measurements, gestational age, sex, mode of delivery, maternal disease and Apgar score were found to be matched in the two studied groups indicating successful randomization as seen in these balanced demographic variables between the groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study was conducted on 44 preterm neonates who were mechanically ventilated for respiratory distress syndrome (RDS). Then they were allocated randomly to one of 2 groups in order by admission: Group A: it included 22 patients on whom the recruitment manoeuvre was applied guided by lung ultrasonography. Group B: it included 22 patients on whom the recruitment maneuver was not ultrasound guided. This is considered the control group.
| Arm | Type | Receives |
|---|---|---|
| US guided lung recruitment | Experimental | Other: lung recruitment maneuver, Other: tracheal IL-6 level, Other: US guided lung recruitment maneuverGroup A: it included 22 patients on whom the recruitment manoeuvre was applied guided by lung ultrasonography. |
| Non US guided lung recruitment | Other | Other: lung recruitment maneuver, Other: tracheal IL-6 levelGroup B: it included 22 patients on whom the recruitment maneuver was not ultrasound guided. This is considered the control group. |
Who may qualify
- Ages
- 1 hour to 2 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Gestational age ≤ 36 weeks.
- In need for invasive mechanical ventilation for RDS according to Downes Score .
Key exclusion criteria (8 listed)
- excluded:
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 |
|---|---|---|
| lung recruitment maneuverLung recruitment maneuver done for ventilated preterm neonates diagnosed with respiratory distress syndrome | Other | Non US guided lung recruitment, US guided lung recruitment |
| tracheal IL-6 leveltracheal IL-6 level was measured before and after recruitment maneuver | Other | Non US guided lung recruitment, US guided lung recruitment |
| US guided lung recruitment maneuverLung recruitment maneuver done for ventilated preterm neonates diagnosed with respiratory distress syndrome guided by lung ultrasound | Other | US guided lung recruitment |
Primary outcome
Lung ultrasound and diagnosis of respiratory distress syndrome
Time frame: 1 year
Forty four preterm neonates diagnosed with respiratoey distress syndrome had lung ultrasound assessment . Its grading was N=normal (presence of lung sliding with A lines or fewer than two isolated B lines) , B1=multiple well-defined B lines , B2=multiple coalescent B lines , C=Consolidation.
Lung ultrasound and recruitment maneuver
Time frame: 1 year
An ultrasound re aeration score is calculated from changes in the ultrasound pattern of each region examined during the recruitment maneuver (N,B1,B2,C).
Lung ultrasound guided recruitment maneuver and the period of oxygen dependency.
Time frame: 1 year
The relation between early lung recruitment maneuver guided by lung ultrasound and how many days requiring oxygen therapy in the NICU .
Lung ultrasound guided recruitment maneuver and the total number of NICU admission days.
Time frame: 1 year
The relation between early lung recruitment maneuver guided by lung ultrasound and how many days requiring admission in the NICU .
Lung ultrasound guided recruitment maneuver and its relation to lung inflammation
Time frame: 1 year
Tracheal aspirate IL-6 is measured initially before recruitment maneuver, and on the third day if still ventilated ,or before extubation if done earlier than the third day.
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 27 Sep 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lung recruitment maneuver, tracheal IL-6 level and US guided lung recruitment maneuver in people with Respiratory Distress Syndrome, Newborn, run by Ain Shams 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 2 inclusion and 8 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 27 Sep 2019. 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?
Lung ultrasound and diagnosis of respiratory distress syndrome (time frame: 1 year). The study lists 5 primary outcomes in all. 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 27 Sep 2019.