NETs: Protection or Harm in Neonatal Inflammation or Infection

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 1
SponsorUniversity of Utah

About this trial

This is a prospective in vitro cell biology study of polymorphonuclear leukocyte (PMN) protein synthesis in response to PAF. PMNs from cord blood of premature human infants at risk for NEC (birth weight between 501 - 1500 grams) and PMNs from cord blood of healthy term infants will be isolated and stimulated with PAF, a biologically active phospholipid implicated in the pathogenesis of NEC. NEC, a disease of prematurity with an incidence of 10.1% of infants born weighing between 501 - 1500 grams, is associated with significant morbidity and mortality. We will compare the protein synthesis of inflammatory modulators, including Interleukin 6 Receptor alpha (IL-6R alpha) and Retinoic Acid Receptor alpha (RAR alpha) proteins to protein synthesis responses already observed in PMNs isolated from healthy adults. Furthermore, we will characterize the expression and activity of the mammalian target of rapamycin (mTOR) translational protein synthesis control pathway in PMNs isolated from preterm and term infants and compare those results with previous observations in PMNs isolated from adults. This pathway is known to regulate IL-6R alpha and RAR alpha protein expression in PMNs isolated from adults. We will also follow those premature infants at risk for NEC clinically to determine which infants develop NEC and what risk factors may be associated with NEC in this population.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients hospitalized in the NICU who were less than or equal to 1500 grams or less than 30 weeks gestational age at birth; Term infants delivered at UUMC without complication, either via cesarean section or vaginal delivery; Cord blood isolated within first hour of life; and parents or guardians must have signed informed consent.

Disqualifiers

Infants with major congenital anomalies will be excluded.

Trial population

Patients hospitalized in the NICU who were less than or equal to 1500 grams or less than 30 weeks gestational age at birth

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

The incidence and survival of premature infants with NEC, defined prospectively as disease meeting criteria for Bell's classification category IIA or greater [See Table 1] as applied by the subject's attending physician.

Time frame
2 years

Secondary outcomes

1

Multiple morbidities and other clinical data will be collected and evaluated with respect to NEC and PMN protein analysis

Time frame
2 years

Other outcomes

Sponsors and contacts

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University of Utah

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator