Meconium Aspiration SyndromeNCT07394322
Interleukin-6 in the Development of Meconium Aspiration Syndrome in Newborn
A study testing serum interleukin 6 in people with Meconium Aspiration Syndrome, run by Benha University at 1 site in Egypt.
Trial summary
This trial is intended to assess the serum levels of interleukin-6 as a predictive factor for the occurrence of meconium aspiration syndrome in infants born with MSAF. Read more about this study
- Who is it for?
- Ages 1 minute to 72 hoursHealthy volunteers can take part
- Conditions the study is for
- Meconium Aspiration Syndrome
- What is being tested?
- serum interleukin 6
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Oct 2025
- 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 minute to 72 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- both genders (Males and females), term infants (above 37 gestational weeks), and born from ladies who have meconium-stained amniotic fluid.
Who cannot join
- Infants born to mothers suspected of having chorioamnionitis (leukocytosis, fever, early membrane rupture (above 18 hours), foul-smelling discharge, tachycardia in the mother or fetus, as well as a positive blood culture),
- those without parental consent,
- those with severe perinatal asphyxia (Stage two or three of hypoxic-ischemic encephalopathy findings according to Sarnat (6)),
- those with severe chorioamnionitis,
- those withcongenital abdominal malformations,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Serum of Interleukin-6 in Predicting the Development of Meconium Aspiration Syndrome in Infants Born With Meconium-Stained Amniotic Fluid
This trial is intended to assess the serum levels of interleukin-6 as a predictive factor for the occurrence of meconium aspiration syndrome in infants born with MSAF.
Read the detailed description
Meconium aspiration syndrome happens when a baby inhales a combination of meconium (the first stool) as well as amniotic fluid into their lungs during the delivery process. Meconium aspiration syndrome is a prevalent reason for significant respiratory failure in full-term or post-term newborns. MAS fluid is responsible for around 8 to 19% of all term deliveries, and meconium aspiration syndrome develops in around five to thirty-three percent of these infants (1).
Interleukin-6 is classified as a cytokine. One of the mediators of inflammation released early in septic shock is critical for initiating the immune response. It also has a role in activating T lymphocytes and B lymphocytes, as well as encouraging lymphocyte proliferation and differentiation. Furthermore, IL-6 possesses strong pyrogenic properties. Additionally, it stimulates the secretion of acute-phase proteins like CRP (2).
IL-6 is a powerful inflammatory agent, as well as its level in the blood has been assessed as a predictive marker in many studies. It is considered one of the foremost indications of prenatal inflammation. Raised levels of interleukin-6 are also observed in both infectious \& non-infectious inflammatory and stressful conditions (2, 3).
Nonspecific symptoms such as a rise in breathing in flattening of the diaphragm, radiography \& irregular linear or patchy patches of atelectasis are observed during the early phase of meconium aspiration syndrome. These signs are present in the early stages of syndrome. However, characteristic indications, for instance, extensive, coarse, and evenly distributed opacities resulting from pneumonia \& interstitial edema, may not manifest until 2-3 days later. Therefore, it is necessary to use indicators to predict whether people are prone to developing MAS. The role of inflammation in the progression of MAS is acknowledged (4).
Prior studies have shown that cytokine levels in Meconium aspiration syndrome experience an elevation in both controlled laboratory conditions (in vitro) as well as living creatures (in vivo) (5).
- Conditions
- Meconium Aspiration Syndrome
- Being tested
- serum interleukin 6
- Keywords
- Meconium aspiration syndrome IL-6: interleukin-6
- Medical subject headings
- Meconium Aspiration Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum interleukin 6Diagnostic test
Serum IL-6: An enzyme-linked immunosorbent test (ELISA) that was developed to quantify the amount of the target bound amongst a matched pair of antibodies was the Human IL-6 solid-phase sandwich ELISA. The wells of the microplate that were provided already had a target-specific antibody coated on them. After that, the immobilized (captured) antibody was bound to samples, standards, or controls by adding them to these wells. Using the second antibody to make a sandwich with the enzyme, antibody, and target complex, a substrate solution was added to make a signal that could be picked up. This signal's strength was proportionate to the original specimen's target concentration.
Steps: To achieve the desired result, remove the desired number of strips \& allow them to reach room temperature. Two to eight degrees Celsius was the temperature at which the unused strips as well as the desiccant were placed back into the sealed aluminum foil bag. The blank wells should be set aside (if the measur
| Study group | Role | What they receive |
|---|---|---|
| 120 term newborns who were born from mothers who had MSAF & admitted to NICU at Benha University hos | Experimental | 120 term newborns who were born from mothers who had MSAF \& admitted to NICU at Benha University hospitals for a period of 1year, starting from February 2022 to February 2023 (Approval No: MS-15-1-2022). Patients were divided according to outcome into two groups: Group 1 (MAS group) contained 60 neonates who developed meconium aspiration syndrome, \& Group 2 (control group) involved 60 neonates who did not develop meconium aspiration syndrome. Receives: Diagnostic Test: serum interleukin 6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum IL-6
Serum IL-6: An enzyme-linked immunosorbent test (ELISA) that was developed to quantify the amount of the target bound amongst a matched pair of antibodies was the Human IL-6 solid-phase sandwich ELISA
Measured: in 3 days of delivery
: Evaluating the levels of interleukin-6 (IL-6) in the blood serum to determine its ability to predict the occurrence of MAS in newborns delivered with meconium-stained amniotic fluid.
Serum IL-6: An enzyme-linked immunosorbent test (ELISA) that was developed to quantify the amount of the target bound amongst a matched pair of antibodies was the Human IL-6 solid-phase sandwich ELISA
Measured: in 3 days of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Jan 2023
- Primary completion1 May 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meconium Aspiration SyndromeStudies of the same condition, open and under way.
- More trials run by Benha 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nashwa farouk Mohamed, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07394322
- Sponsor's protocol ID
- MS-15-1-2022
- Status last verified
- Jan 2026
- First submitted
- 30 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Serum of Interleukin-6 in Predicting the Development of Meconium Aspiration Syndrome in Infants Born With Meconium-Stained Amniotic Fluid
- ClinicalTrials.gov ID
- NCT07394322
- Acronym / sponsor ID
- MS-15-1-2022
- Conditions
- Meconium Aspiration Syndrome
- Keywords
- Meconium aspiration syndrome IL-6: interleukin-6
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 6 Feb 2026 (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 trial is intended to assess the serum levels of interleukin-6 as a predictive factor for the occurrence of meconium aspiration syndrome in infants born with MSAF.
Detailed description
Meconium aspiration syndrome happens when a baby inhales a combination of meconium (the first stool) as well as amniotic fluid into their lungs during the delivery process. Meconium aspiration syndrome is a prevalent reason for significant respiratory failure in full-term or post-term newborns. MAS fluid is responsible for around 8 to 19% of all term deliveries, and meconium aspiration syndrome develops in around five to thirty-three percent of these infants (1).
Interleukin-6 is classified as a cytokine. One of the mediators of inflammation released early in septic shock is critical for initiating the immune response. It also has a role in activating T lymphocytes and B lymphocytes, as well as encouraging lymphocyte proliferation and differentiation. Furthermore, IL-6 possesses strong pyrogenic properties. Additionally, it stimulates the secretion of acute-phase proteins like CRP (2).
IL-6 is a powerful inflammatory agent, as well as its level in the blood has been assessed as a predictive marker in many studies. It is considered one of the foremost indications of prenatal inflammation. Raised levels of interleukin-6 are also observed in both infectious \& non-infectious inflammatory and stressful conditions (2, 3).
Nonspecific symptoms such as a rise in breathing in flattening of the diaphragm, radiography \& irregular linear or patchy patches of atelectasis are observed during the early phase of meconium aspiration syndrome. These signs are present in the early stages of syndrome. However, characteristic indications, for instance, extensive, coarse, and evenly distributed opacities resulting from pneumonia \& interstitial edema, may not manifest until 2-3 days later. Therefore, it is necessary to use indicators to predict whether people are prone to developing MAS. The role of inflammation in the progression of MAS is acknowledged (4).
Prior studies have shown that cytokine levels in Meconium aspiration syndrome experience an elevation in both controlled laboratory conditions (in vitro) as well as living creatures (in vivo) (5).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 120 term newborns who were born from mothers who had MSAF & admitted to NICU at Benha University hos | Experimental | Diagnostic Test: serum interleukin 6120 term newborns who were born from mothers who had MSAF \& admitted to NICU at Benha University hospitals for a period of 1year, starting from February 2022 to February 2023 (Approval No: MS-15-1-2022). Patients were divided according to outcome into two groups: Group 1 (MAS group) contained 60 neonates who developed meconium aspiration syndrome, \& Group 2 (control group) involved 60 neonates who did not develop meconium aspiration syndrome. |
Who may qualify
- Ages
- 1 minute to 72 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- both genders (Males and females), term infants (above 37 gestational weeks), and born from ladies who have meconium-stained amniotic fluid.
Key exclusion criteria (5 listed)
- Infants born to mothers suspected of having chorioamnionitis (leukocytosis, fever, early membrane rupture (above 18 hours), foul-smelling discharge, tachycardia in the mother or fetus, as well as a positive blood culture),
- those without parental consent,
- those with severe perinatal asphyxia (Stage two or three of hypoxic-ischemic encephalopathy findings according to Sarnat (6)),
- those with severe chorioamnionitis,
- those withcongenital abdominal malformations,
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 |
|---|---|---|
| serum interleukin 6Serum IL-6: An enzyme-linked immunosorbent test (ELISA) that was developed to quantify the amount of the target bound amongst a matched pair of antibodies was the Human IL-6 solid-phase sandwich ELISA. The wells of the microplate that were provided already had a target-specific antibody coated on them. After that, the immobilized (captured) antibody was bound to samples, standards, or controls by adding them to these wells. Using the second antibody to make a sandwich with the enzyme, antibody, and target complex, a substrate solution was added to make a signal that could be picked up. This signal's strength was proportionate to the original specimen's target concentration. Steps: To achieve the desired result, remove the desired number of strips \& allow them to reach room temperature. Two to eight degrees Celsius was the temperature at which the unused strips as well as the desiccant were placed back into the sealed aluminum foil bag. The blank wells should be set aside (if the measur | Diagnostic test | 120 term newborns who were born from mothers who had MSAF & admitted to NICU at Benha University hos |
Primary outcome
serum IL-6
Time frame: in 3 days of delivery
Serum IL-6: An enzyme-linked immunosorbent test (ELISA) that was developed to quantify the amount of the target bound amongst a matched pair of antibodies was the Human IL-6 solid-phase sandwich ELISA
: Evaluating the levels of interleukin-6 (IL-6) in the blood serum to determine its ability to predict the occurrence of MAS in newborns delivered with meconium-stained amniotic fluid.
Time frame: in 3 days of delivery
Serum IL-6: An enzyme-linked immunosorbent test (ELISA) that was developed to quantify the amount of the target bound amongst a matched pair of antibodies was the Human IL-6 solid-phase sandwich ELISA
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 6 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Meconium Aspiration Syndrome
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CAffeine Use in Prolonged Oxygen Use in meConium aspIration Syndrome in Neonatal Outcomes (CAPUCINO)
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RecruitingObservational study
Predicting the Need for Prolonged Respiratory Support in Neonates Delivered in a Lower-Level NICU Setting
Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome in Premature Infant
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Pulmonary Function Using Non-invasive Forced Oscillometry
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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 serum interleukin 6 in people with Meconium Aspiration Syndrome, run by Benha 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 5 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 6 Feb 2026. 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?
serum IL-6 (time frame: in 3 days of delivery). The study lists 2 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 6 Feb 2026.