Role of Placenta in the Inflammatory Responses in Fetal-Neonatal Encephalopathy

Study ID
STU 082013-023

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Parkland Health & Hospital System

Contact
Imran Mir
214/648-2835
imran.mir@utsouthwestern.edu

Principal Investigator
Imran Mir

Summary

This is a one and half year (february 2014 to June 2015) prospective cohort study that will be conducted at Parkland Hospital. During the study period, we will obtain blood samples from double clamped umbilical cords after delivery of neonates with evidence of perinatal Ha and from a control group without evidence of perinatal Ha and delivery by ceserean section without labor or vaginal delivery with labor to measure plasma levels of cytokines and neuronal biomarkers in blood samples from the umbilical vein and artery. The placenta of each neonate with Ha entered into the study is routinelly sent to pathology and will be examined as is the standard of practice. Control placentae will be handled similary. We will determine whether the placenta contributes to the inflammatory responses in fetal-neonatal Ha and encephalopathy or provides a site for the clearance of these cytokines using the paried blood samples. We also will determine if the V-a difference in the levels of cytokines and neuronal biomarkers will help identify neonates who will develop encephalopathy and thus permits their stratification by severity. if there is evidence of placental synthesis of these biomarkers, we will determine their expression within the placental tissue and their cellular sources. We estimate there will be ~12,000 births/year at Parkland Hospital during the study period and that 1.5% of neonates will have evidence of fetal Ha with neonatal encephalopathy. neonates eligible for the study will include those born at [GreaterThanorequalTo]36 weeks of gestation and with a birth weight [GreaterThanorequalTo]1800 gm. neonates will include controls without Ha and those with:

Group 1 (Ha) . This will include neonates with complications prior to and during delivery and with evidence of compromised fetal well-being, which will include the presence of a non-reassuring fetal heart pattern, apgar score [Less Than]5 at 5 min, the need for resuscitation at birth, and the need for admission to the neonatal intensive Care nursery.

Group 2 (Control) . This will include neonates born to women with low-risk pregnancies, who are born at term either by scheduled repeat cesearan delivery without labor or vaginal delivery in the presence of labor.

immediately after delivery of the neonate, a segment of umbilical cord will be double clamped and blood obtained from the umbilical arteries and vein using 5-ml heparinized plastic syringes. Samples will be placed on ice, centrifuged at 4[Degrees]C for 10 min at 2700 rpm and the plasma stored at [?]80[Degrees]C in the laboratories of Dr Rosenfeld until analysis for inflammatory cytokines (iL-1[MiCRo-SYMBoL], iL-6, iL-8, TnF[RegisteredTM]) and neuronal biomarkers (uCH-L1 and GFaP eCL-ia ) using eLiSa. Two 0.5 cm fresh placental tissue samples will be obtained from each placenta in the delivery room, transported in PBS to Dr Rosenfeld's Laboratories and stored there. after completing the protein assays, the placental tissues maintained in the pathology lab will be analyzed using specific antisera and immunohistochemistry.

Participant Eligibility

Neonates born >36 weeks of gestation and birth weight >1800 gms who are delivered at Parkland Hospital.
Group 1 (HA). This group of neonates will include those with complications prior to and during delivery and with evidence of compromised fetal well-being, e.g., the presence of a non-reassuring fetal heart pattern, Apgar score <5 at 5 min, the need for resuscitation at birth, and the need for admission to the Neonatal Intensive Care Nursery.

Group 2 (Control). This will include neonates born to women with low-risk pregnancies, who are born at term either by scheduled ceserean section without labor or by vaginal delivery in the presence of labor.