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

Preterm Infant Clinical Trial

Official title:

A Pilot Study to Evaluate the Utility of Placental/Umbilical Cord Blood (PUCB) in Early Onset Neonatal Sepsis (EONS) in Very Low Birth Weight Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03694613
• Other study ID #: 18-0165
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: August 20, 2020

Study information

• Verified date: November 2020
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

Early Onset Neonatal Sepsis (EONS) is common in preterm infants, and it is associated with high morbidity and mortality, especially if not diagnosed early. Currently the baseline workup is done using blood samples from the infant to perform Blood culture, CBC, I/T ratio. These tests have shown to have low sensitivity and specificity to diagnosis EONS.

PUCB can be another safe source of blood which is useful, painless and simple to collect. As CBC, I/T ratio and blood culture may not be enough to diagnose EONS we will add IL-6 and CRP which will increase sensitivity and specificity to diagnose EONS in preterm infants without collecting blood from the infants.

This study may be a step to decrease iatrogenic blood loss to diagnose EONS. The primary outcome of the current research will be to find out the utility of PUCB in diagnosing EOS in preterm infants (<30 weeks and <1250 grams birth weight). Using PUCB can increase the accuracy to diagnose Sepsis in Preterm infants, and it will also conserve blood in the extremely premature infants while reducing hemodynamic instability due to acute blood loss.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: August 20, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Day

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Early-Onset Neonatal Sepsis
• Neonatal Sepsis
• Preterm Infant
• Sepsis
• Toxemia
• Umbilical Cord

Intervention

Other:
• Placental/Umbilical Cord Blood sample
After infant is delivered, placenta along with clamped umbilical cord Blood will be obtained from the ObGyn team. One umbilical clamp will be placed at the umbilical end, and the other clamp will be placed on the placental end of the umbilical cord. Then the umbilical cord will be cut between the clamps. The umbilical cord will be cleaned three times with 2% chlorhexidine, plus 70% isopropyl alcohol under sterile conditions (sterile gloves). Cord blood samples will be collected using vacutainer blood collecting system with a sterile 22-gauge needle. We will collect 3 - 4 ml of blood.

Locations

Country	Name	City	State
United States	Sergio Mauricio Lerma Narvaez	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

References & Publications (11)

Baer VL, Lambert DK, Carroll PD, Gerday E, Christensen RD. Using umbilical cord blood for the initial blood tests of VLBW neonates results in higher hemoglobin and fewer RBC transfusions. J Perinatol. 2013 May;33(5):363-5. doi: 10.1038/jp.2012.127. Epub 2012 Oct 4. — View Citation

Beeram MR, Loughran C, Cipriani C, Govande V. Utilization of umbilical cord blood for the evaluation of group B streptococcal sepsis screening. Clin Pediatr (Phila). 2012 May;51(5):447-53. doi: 10.1177/0009922811431882. Epub 2011 Dec 22. — View Citation

Brown DR, Kutler D, Rai B, Chan T, Cohen M. Bacterial concentration and blood volume required for a positive blood culture. J Perinatol. 1995 Mar-Apr;15(2):157-9. — View Citation

Christensen RD, Lambert DK, Baer VL, Montgomery DP, Barney CK, Coulter DM, Ilstrup S, Bennett ST. Postponing or eliminating red blood cell transfusions of very low birth weight neonates by obtaining all baseline laboratory blood tests from otherwise discarded fetal blood in the placenta. Transfusion. 2011 Feb;51(2):253-8. doi: 10.1111/j.1537-2995.2010.02827.x. Epub 2010 Aug 16. — View Citation

Hornik CP, Benjamin DK, Becker KC, Benjamin DK Jr, Li J, Clark RH, Cohen-Wolkowiez M, Smith PB. Use of the complete blood cell count in early-onset neonatal sepsis. Pediatr Infect Dis J. 2012 Aug;31(8):799-802. doi: 10.1097/INF.0b013e318256905c. — View Citation

Joram N, Boscher C, Denizot S, Loubersac V, Winer N, Roze JC, Gras-Le Guen C. Umbilical cord blood procalcitonin and C reactive protein concentrations as markers for early diagnosis of very early onset neonatal infection. Arch Dis Child Fetal Neonatal Ed. 2006 Jan;91(1):F65-6. — View Citation

Laborada G, Rego M, Jain A, Guliano M, Stavola J, Ballabh P, Krauss AN, Auld PA, Nesin M. Diagnostic value of cytokines and C-reactive protein in the first 24 hours of neonatal sepsis. Am J Perinatol. 2003 Nov;20(8):491-501. — View Citation

Malik A, Hui CP, Pennie RA, Kirpalani H. Beyond the complete blood cell count and C-reactive protein: a systematic review of modern diagnostic tests for neonatal sepsis. Arch Pediatr Adolesc Med. 2003 Jun;157(6):511-6. Review. — View Citation

Meena J, Charles MV, Ali A, Ramakrishnan S, Gosh S, Seetha KS. Utility of cord blood culture in early onset neonatal sepsis. Australas Med J. 2015 Aug 31;8(8):263-7. doi: 10.4066/AMJ.2015.2460. eCollection 2015. — View Citation

Ng PC. Diagnostic markers of infection in neonates. Arch Dis Child Fetal Neonatal Ed. 2004 May;89(3):F229-35. Review. — View Citation

Qazi SA, Stoll BJ. Neonatal sepsis: a major global public health challenge. Pediatr Infect Dis J. 2009 Jan;28(1 Suppl):S1-2. doi: 10.1097/INF.0b013e31819587a9. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	White Blood Cell Count (WBC) (1)	Normal Range approximately 6,000 - 30,000 cell/mm3.	Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord.
Primary	White Blood Cell Count (WBC) (1) INFANT BLOOD	Normal Range: 6.000 - 30.000 cell/mm3.	Completed during the first 6 hours after birth. This sample is going to be taken directly from the participant.
Primary	I/T Ratio (Immature/Total Immature Neutrophil).I/T Ratio Was Calculated by Dividing Immature White Cell Count Total White Cell Count	Normal Range of I/T ratio: <0.2.	Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord.
Primary	I/T Ratio (Immature/Total Immature Neutrophil Ratio) INFANT BLOOD	Normal Range: <0.2	Completed during the first 12 hours after birth. This sample is going to be taken directly from the participant.
Primary	CRP (C-Reactive Protein)(1)	Normal Range: < 10,000 ng/mL	Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord.
Primary	CRP (C-Reactive Protein)(2) INFANT BLOOD	Normal Range: <10.000ng/mL	Completed during the first 6 hours after birth. This sample was taken directly from the participant.
Primary	IL-6 (1)	Normal Range: 0-10.2 pg/ml	Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord.
Primary	IL-6 (Interleukin-6) INFANTS BLOOD	Normal Range: <100 pg/mL	Completed during the first 6hours after birth. This sample is going to be taken directly from the participant.
Primary	Procalcitonin PUBC	Blood was taken from PUBC after delivery	Within 30 minutes after delivery
Primary	Procalcitonin Level Was Measured in the Blood From Placenta and From the Baby Within 6 Hours After Birth	Procalcitonin levels	Procalcitonin Level was measured in the blood from placenta and in Infant's Blood (within 6 hours)
Primary	Number of Participants With Negative Blood Culture From Blood Drawn From Placenta and From Baby Within 6 Hours After Birth	Normal Range: Blood Culture Negative	Blood sample drawn from placenta and from baby within 6 hours after birth.
Primary	Presepsin- PUBC	Presepsin level was measured in the blood drawn from placenta and from the baby within 6 hours after birth	First 30 min after birth
Primary	Presepsin-Infant's Blood	Levels of presepsin	First 30 min after birth
Primary	Number of Participants With a Negative Blood Culture	Blood is taken from infants after birth	first 2 hours after birth