NCT07394322

Interleukin-6 in the Development of Meconium Aspiration Syndrome in Newborn

The Role of Serum of Interleukin-6 in Predicting the Development of Meconium Aspiration Syndrome in Infants Born With Meconium-Stained Amniotic Fluid

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Benha University · Academic / Other
• Sex: All
• Age: 1 Minute – 72 Hours
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	serum interleukin 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. 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

Timeline

• Start date: 2023-01-01
• Primary completion: 2025-05-01
• Completion: 2025-10-01
• First posted: 2026-02-06
• Last updated: 2026-02-06

Locations

1 site across 1 country: Egypt