CompletedNot Applicable

Utility of Placental/Umbilical Cord Blood in Early Onset Neonatal Sepsis in Very Low Birth Weight Infants

United States65 participantsStarted 2019-06-01

Plain-language summary

This study evaluates the utility of placental/umbilical cord blood (PUCB) to perform the baseline workup testing for EONS in Very Low Birth Weight Infants: CBC (Complete Blood Count) with differential, Immature/Total ratio (I/T ratio), and blood culture along with CRP and IL-6 levels. A cohort (63 subjects) of preterm infants will be recruited. All the participants will be evaluated for sepsis using placental/umbilical cord blood (PUCB) and subject blood sample during the first 12 hours of life (after birth).

Who can participate

Age range

1 Day

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Infants \<34 weeks' gestational Exclusion Criteria: * Known congenital or chromosomal anomalies * Congenital heart disease (other than Patent Ductus Arteriosus, Patent Foramen Ovale or Atrial Septum Defect) * Vaginal bleeding at admission

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

White Blood Cell Count (WBC) (1)

Timeframe: Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord.

White Blood Cell Count (WBC) (1) INFANT BLOOD

Timeframe: Completed during the first 6 hours after birth. This sample is going to be taken directly from the participant.

I/T Ratio (Immature/Total Immature Neutrophil).I/T Ratio Was Calculated by Dividing Immature White Cell Count Total White Cell Count

Timeframe: Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord.

I/T Ratio (Immature/Total Immature Neutrophil Ratio) INFANT BLOOD

Timeframe: Completed during the first 12 hours after birth. This sample is going to be taken directly from the participant.

CRP (C-Reactive Protein)(1)

Timeframe: Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord.

CRP (C-Reactive Protein)(2) INFANT BLOOD

Timeframe: Completed during the first 6 hours after birth. This sample was taken directly from the participant.

Trial details

NCT IDNCT03694613

SponsorThe University of Texas Medical Branch, Galveston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-06-01

Results submitted2021-02-04

View on ClinicalTrials.gov More Preterm Infant trials

Plain-language summary

Who can participate

Age range

1 Day

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

White Blood Cell Count (WBC) (1)

Timeframe: Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord.

White Blood Cell Count (WBC) (1) INFANT BLOOD

Timeframe: Completed during the first 6 hours after birth. This sample is going to be taken directly from the participant.

I/T Ratio (Immature/Total Immature Neutrophil).I/T Ratio Was Calculated by Dividing Immature White Cell Count Total White Cell Count

Timeframe: Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord.

I/T Ratio (Immature/Total Immature Neutrophil Ratio) INFANT BLOOD

Timeframe: Completed during the first 12 hours after birth. This sample is going to be taken directly from the participant.

CRP (C-Reactive Protein)(1)

Timeframe: Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord.

CRP (C-Reactive Protein)(2) INFANT BLOOD

Timeframe: Completed during the first 6 hours after birth. This sample was taken directly from the participant.