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

NCT07394322 | Completed DMC

• 1 other identifier: MS-15-1-2022
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Meconium Aspiration Syndrome

Keywords

Meconium aspiration syndrome IL-6: interleukin-6

Outcome Measures

Primary Outcomes (2)

• 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

  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

  in 3 days of delivery

Study Arms (1)

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.

Diagnostic Test: serum interleukin 6

Interventions

serum interleukin 6 DIAGNOSTIC_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

120 term newborns who were born from mothers who had MSAF & admitted to NICU at Benha University hos

Eligibility Criteria

• Age: 1 Minute - 72 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• both genders (Males and females), term infants (above 37 gestational weeks), and born from ladies who have meconium-stained amniotic fluid.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha Faculty of Medicine

Banhā, 15312, Egypt

Location

MeSH Terms

Conditions

Meconium Aspiration Syndrome

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of pediatrics

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 6, 2026
• Study Start: January 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: October 1, 2025
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)