Preterm InfantNCT03694613
Utility of Placental/Umbilical Cord Blood in Early Onset Neonatal Sepsis in Very Low Birth Weight Infants
A study testing Placental/Umbilical Cord Blood sample in people with Preterm Infant and Early-Onset Neonatal Sepsis, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 1 day
- Conditions the study is for
- Preterm Infant, Early-Onset Neonatal Sepsis, Umbilical Cord
- What is being tested?
- Placental/Umbilical Cord Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 20 Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 day
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants <34 weeks' gestational
Who cannot join
- Known congenital or chromosomal anomalies
- Congenital heart disease (other than Patent Ductus Arteriosus, Patent Foramen Ovale or Atrial Septum Defect)
- Vaginal bleeding at admission
Trial locations and contacts
1 site in 1 country.
United States1 site
Sergio Mauricio Lerma Narvaez
Galveston, Texas, 77550
About this study
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
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).
Read the detailed 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.
- Conditions
- Preterm Infant, Early-Onset Neonatal Sepsis, Umbilical Cord
- Being tested
- Placental/Umbilical Cord Blood sample
- Keywords
- Preterm Infant, Early-Onset Neonatal Sepsis, Umbilical Cord, Complete Cell Count, Placenta, Blood Culture
- Medical subject headings
- Premature Birth, Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placental/Umbilical Cord Blood sampleOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Placental/Umbilical Cord Blood sample | Other | Placental/Umbilical Cord Blood sample will be collected after delivery from every participant. Receives: Other: Placental/Umbilical Cord Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
White Blood Cell Count (WBC) (1)
Normal Range approximately 6,000 - 30,000 cell/mm3.
Measured: 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
Normal Range: 6.000 - 30.000 cell/mm3.
Measured: 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
Normal Range of I/T ratio: <0.2.
Measured: 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
Normal Range: <0.2
Measured: Completed during the first 12 hours after birth. This sample is going to be taken directly from the participant.
CRP (C-Reactive Protein)(1)
Normal Range: < 10,000 ng/mL
Measured: 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
Normal Range: <10.000ng/mL
Measured: Completed during the first 6 hours after birth. This sample was taken directly from the participant.
IL-6 (1)
Normal Range: 0-10.2 pg/ml
Measured: Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord.
IL-6 (Interleukin-6) INFANTS BLOOD
Normal Range: <100 pg/mL
Measured: Completed during the first 6hours after birth. This sample is going to be taken directly from the participant.
Procalcitonin PUBC
Blood was taken from PUBC after delivery
Measured: Within 30 minutes after delivery
Procalcitonin Level Was Measured in the Blood From Placenta and From the Baby Within 6 Hours After Birth
Procalcitonin levels
Measured: Procalcitonin Level was measured in the blood from placenta and in Infant's Blood (within 6 hours)
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
Measured: Blood sample drawn from placenta and from baby within 6 hours after birth.
Presepsin- PUBC
Presepsin level was measured in the blood drawn from placenta and from the baby within 6 hours after birth
Measured: First 30 min after birth
Presepsin-Infant's Blood
Levels of presepsin
Measured: First 30 min after birth
Number of Participants With a Negative Blood Culture
Blood is taken from infants after birth
Measured: first 2 hours after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start1 Jun 2019
- Primary completion1 Jun 2020
- Study completion20 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Preterm InfantStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- sergio M Lerma Narvaez, Principal investigator, UTMB, Galveston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03694613
- Sponsor's protocol ID
- 18-0165
- Status last verified
- Nov 2020
- First submitted
- 28 Sep 2018
- Last updated
- 10 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. No abstract available.
PubMed 19106756Brown 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.
PubMed 7595778Hornik 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.
PubMed 22531231Malik 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. doi: 10.1001/archpedi.157.6.511.
PubMed 12796229Ng PC. Diagnostic markers of infection in neonates. Arch Dis Child Fetal Neonatal Ed. 2004 May;89(3):F229-35. doi: 10.1136/adc.2002.023838.
PubMed 15102726Laborada 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. doi: 10.1055/s-2003-45382.
PubMed 14703598Christensen 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.
PubMed 20723166Meena 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.
PubMed 26392823Beeram 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.
PubMed 22199177Joram 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. doi: 10.1136/adc.2005.074245.
PubMed 16371391Baer 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.
PubMed 23047426
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03694613
- Acronym / sponsor ID
- 18-0165
- Conditions
- Preterm Infant, Early-Onset Neonatal Sepsis, Umbilical Cord
- Keywords
- Preterm Infant, Early-Onset Neonatal Sepsis, Umbilical Cord, Complete Cell Count, Placenta, Blood Culture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 20 Aug 2020 (actual)
- First posted
- 3 Oct 2018 (actual)
- Results
- Posted 10 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Placental/Umbilical Cord Blood sample | Other | Other: Placental/Umbilical Cord Blood samplePlacental/Umbilical Cord Blood sample will be collected after delivery from every participant. |
Who may qualify
- Ages
- Up to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants <34 weeks' gestational
Key exclusion criteria (3 listed)
- Known congenital or chromosomal anomalies
- Congenital heart disease (other than Patent Ductus Arteriosus, Patent Foramen Ovale or Atrial Septum Defect)
- Vaginal bleeding at admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placental/Umbilical Cord Blood sampleAfter 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. | Other | Placental/Umbilical Cord Blood sample |
Primary outcome
White Blood Cell Count (WBC) (1)
Time frame: Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord.
Normal Range approximately 6,000 - 30,000 cell/mm3.
White Blood Cell Count (WBC) (1) INFANT BLOOD
Time frame: Completed during the first 6 hours after birth. This sample is going to be taken directly from the participant.
Normal Range: 6.000 - 30.000 cell/mm3.
I/T Ratio (Immature/Total Immature Neutrophil).I/T Ratio Was Calculated by Dividing Immature White Cell Count Total White Cell Count
Time frame: Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord.
Normal Range of I/T ratio: <0.2.
I/T Ratio (Immature/Total Immature Neutrophil Ratio) INFANT BLOOD
Time frame: Completed during the first 12 hours after birth. This sample is going to be taken directly from the participant.
Normal Range: <0.2
CRP (C-Reactive Protein)(1)
Time frame: Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord.
Normal Range: < 10,000 ng/mL
CRP (C-Reactive Protein)(2) INFANT BLOOD
Time frame: Completed during the first 6 hours after birth. This sample was taken directly from the participant.
Normal Range: <10.000ng/mL
IL-6 (1)
Time frame: Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord.
Normal Range: 0-10.2 pg/ml
IL-6 (Interleukin-6) INFANTS BLOOD
Time frame: Completed during the first 6hours after birth. This sample is going to be taken directly from the participant.
Normal Range: <100 pg/mL
Procalcitonin PUBC
Time frame: Within 30 minutes after delivery
Blood was taken from PUBC after delivery
Procalcitonin Level Was Measured in the Blood From Placenta and From the Baby Within 6 Hours After Birth
Time frame: Procalcitonin Level was measured in the blood from placenta and in Infant's Blood (within 6 hours)
Procalcitonin levels
Number of Participants With Negative Blood Culture From Blood Drawn From Placenta and From Baby Within 6 Hours After Birth
Time frame: Blood sample drawn from placenta and from baby within 6 hours after birth.
Normal Range: Blood Culture Negative
Presepsin- PUBC
Time frame: First 30 min after birth
Presepsin level was measured in the blood drawn from placenta and from the baby within 6 hours after birth
Presepsin-Infant's Blood
Time frame: First 30 min after birth
Levels of presepsin
Number of Participants With a Negative Blood Culture
Time frame: first 2 hours after birth
Blood is taken from infants after birth
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19106756Qazi 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. No abstract available.
- Background: PubMed 7595778Brown 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.
- Background: PubMed 22531231Hornik 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.
- Background: PubMed 12796229Malik 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. doi: 10.1001/archpedi.157.6.511.
- Background: PubMed 15102726Ng PC. Diagnostic markers of infection in neonates. Arch Dis Child Fetal Neonatal Ed. 2004 May;89(3):F229-35. doi: 10.1136/adc.2002.023838.
- Background: PubMed 14703598Laborada 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. doi: 10.1055/s-2003-45382.
- Background: PubMed 20723166Christensen 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.
- Background: PubMed 26392823Meena 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.
- Background: PubMed 22199177Beeram 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.
- Background: PubMed 16371391Joram 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. doi: 10.1136/adc.2005.074245.
- Background: PubMed 23047426Baer 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.
- Individual participant dataSharing planned: No
Related trials for Preterm Infant
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sergio M Lerma Narvaez principal investigator
UTMB, Galveston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Placental/Umbilical Cord Blood sample in people with Preterm Infant and Early-Onset Neonatal Sepsis, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
White Blood Cell Count (WBC) (1) (time frame: Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord.). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03694613, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2021.