Premature Birth of NewbornDCCNCT02478684
Delayed Cord Clamping in Preterm Neonates
A study testing 30 Seconds of placental blood transfusion and 60 Seconds of placental blood transfusion in people with Premature Birth of Newborn and Infant, Very Low Birth Weight, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
Delayed cord clamping (DCC) from 30 to 60 seconds allows blood to continue to flow from the placenta through the umbilical cord to the infant, thus resulting in a placental transfusion. Read more about this study
- Who is it for?
- Ages 28 to 35 weeks
- Conditions the study is for
- Premature Birth of Newborn, Infant, Very Low Birth Weight, Delayed Separation of Umbilical Cord
- What is being tested?
- 30 Seconds of placental blood transfusion and 60 Seconds of placental blood transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 30 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 28 to 35 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Premature infants between 28 and 34 6/7 weeks
- Parents have given informed consent
Who cannot join
- Suspected placental abruption
- Bleeding from placenta previa
- Terminal bradycardia
- Cord prolapse
- Meconium
- Any major congenital anomalies
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell medical College
New York, New York, 10065
About this study
Official title: The Effects of Delayed Cord Clamping on Postnatal Circulatory Status in Preterm Neonates
Delayed cord clamping (DCC) from 30 to 60 seconds allows blood to continue to flow from the placenta through the umbilical cord to the infant, thus resulting in a placental transfusion. This transfusion may improve circulating volume at birth leading to a smoother postnatal transition and overall improved outcome for preterm infants. The average blood volume delivered with DCC up to 90 seconds in preterm infants has been estimated to be about 12 ml per kg with vaginal deliveries resulting in slightly higher transfusions compared to cesarean deliveries. Several several short-term benefits have been described including a reduction in the need for blood transfusions as well as a possible reduction in intraventricular hemorrhage and necrotizing enterocolitis. All mothers with threatened preterm delivery between 28 and 34 6/7 weeks will be approached for the study. Following consent, the infant will be randomly assigned to either a 30 or 60 second delay in cord clamping in the delivery room. If the infant is not breathing by 30 seconds, the cord will be clamped and the infant moved to a resuscitation area. The primary outcome is a 3 percent difference in the hematocrit at one hour (routinely obtained on all babies). With approximately 75 neonates in each group (30 and 60 second DCC), there is 80% power to detect a difference in the mean hematocrit of 3% using a two-sample t-test with a 0.05 two-sided significance level.
Read the detailed description
Placental transfusion at birth is thought to have immediate, short-term and long-term benefits for the neonate. Delaying cord clamping is thought to allow for a smoother postnatal transition as the necessary cardiopulmonary changes take place specifically when the infant establishes spontaneous respirations and/or experimentally when mechanical ventilation is initiated. By allowing the infant to establish respirations, the pulmonary vascular bed is able to relax prior to the removal of the low-resistance placental vascular bed, thus avoiding a reflexive bradycardia. A 2012 Cochrane review of DCC in preterm infants has suggested several short-term benefits including a reduction in the need for blood transfusions as well as a possible reduction in intraventricular hemorrhage and necrotizing enterocolitis. The American College of Obstetrics and Gynecology (ACOG) published a committee opinion in December of 2012 stating that current evidence supports delayed cord clamping in preterm infants. They go on to support that DCC up to 30-60 seconds has been shown to improve transitional circulation, decreased the need for blood transfusion, and may even reduce the incidence of intraventricular hemorrhage. The primary objective of this study is to determine if delayed cord clamping up to 60 seconds leads to an improved postnatal transition as demonstrated by higher initial hematocrit at 30 minutes in preterm neonates born between 28 and 34+6/7 weeks gestation. The investigators will determine whether there is a significant difference in this primary outcome with delays of 30 seconds versus 60 seconds. A secondary objective will be to determine the effect of DCC on additional measures such as Apgar scores, initial heart rate, initial temperature, blood pressure measures, fluid resuscitation and/or the need for pressors, peak bilirubin, and days on phototherapy.
Inclusion Criteria: Preterm infants born between 28 and 34+6/7 weeks gestation. Exclusion Criteria: Infant with suspected placental abruption, bleeding from placenta previa, terminal bradycardia, cord prolapse, meconium, or any major congenital anomalies.
All mothers with threatened preterm delivery between 28 and 34 6/7 weeks will be approached for the study. If consent is obtained, the infant will be randomly assigned to either a 30 or 60 second delay of cord clamping in the delivery room. All delivery room staff will be notified of the assignment prior to the delivery. The Neonatal Intensive Care Unit (NICU) staff will be present at each delivery, including a NICU Fellow, a NICU nurse, and/or an neonatal nurse practitioner or pediatric resident. In the case of a C-Section, the NICU fellow will be in sterile gown and gloves in order to assess the infant on the sterile field. The timer will start immediately following delivery of the entire infant. In the case of a vaginal delivery the infant will be placed between the mother's legs or on the mother's abdomen in the case of a cesarean section. The fellow will evaluate the infant to assess onset of respirations while stimulating and covering the infant in a plastic wrap. If the infant has good tone and sustained breathing, the umbilical cord will continue to be unclamped though a maximum of 60 seconds. If the infant has not begun to establish respirations at 30 seconds, the cord will be clamped and the infant will be transferred to the radiant warmer regardless of their original assignment.
The primary outcome is a 3 percent difference in the hematocrit at one hour (routinely obtained on all babies). With approximately 75 neonates in each group (30 and 60 second DCC), there is 80% power to detect a difference in the mean hematocrit of 3% using a two-sample t-test with a 0.05 two-sided significance level.
- Conditions
- Premature Birth of Newborn, Infant, Very Low Birth Weight, Delayed Separation of Umbilical Cord, Placental Transfusion
- Being tested
- 30 Seconds of placental blood transfusion, 60 Seconds of placental blood transfusion
- Keywords
- delayed cord clamping, premature infants, randomized study, hematocrit
- Medical subject headings
- Premature Birth, Fetofetal Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30 Seconds of placental blood transfusionOther
Also called 30 Seconds of Delayed Cord Clamping
By delaying clamping of the cord blood for 30 seconds, blood will be allowed to move from the placenta to the premature infant
60 Seconds of placental blood transfusionOther
Also called 60 Seconds of Delayed Cord Clamping
By delaying clamping of the cord blood for 60 seconds, blood will be allowed to move from the placenta to the premature infant
| Study group | Role | What they receive |
|---|---|---|
| 30 seconds of DCC | Active comparator | 30 Seconds of placental blood transfusion Receives: Other: 30 Seconds of placental blood transfusion |
| 60 seconds DCC | Active comparator | 60 Seconds of placental blood transfusion Receives: Other: 60 Seconds of placental blood transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Hematocrit at one hour of life
There should be a 3% difference between the 30 second and 60 second arms.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startJul 2015
- Primary completion30 Mar 2019
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Premature Birth of NewbornStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Perlman, MB Ch B, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02478684
- Sponsor's protocol ID
- 1411015633
- Acronym
- DCC
- Status last verified
- Oct 2019
- First submitted
- 11 Jun 2015
- Last updated
- 30 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Kugelman A, Borenstein-Levin L, Riskin A, Chistyakov I, Ohel G, Gonen R, Bader D. Immediate versus delayed umbilical cord clamping in premature neonates born < 35 weeks: a prospective, randomized, controlled study. Am J Perinatol. 2007 May;24(5):307-15. doi: 10.1055/s-2007-981434. Epub 2007 May 21.
PubMed 17516307Mercer JS, McGrath MM, Hensman A, Silver H, Oh W. Immediate and delayed cord clamping in infants born between 24 and 32 weeks: a pilot randomized controlled trial. J Perinatol. 2003 Sep;23(6):466-72. doi: 10.1038/sj.jp.7210970.
PubMed 13679933Mercer JS, Vohr BR, McGrath MM, Padbury JF, Wallach M, Oh W. Delayed cord clamping in very preterm infants reduces the incidence of intraventricular hemorrhage and late-onset sepsis: a randomized, controlled trial. Pediatrics. 2006 Apr;117(4):1235-42. doi: 10.1542/peds.2005-1706.
PubMed 16585320Oh W, Fanaroff AA, Carlo WA, Donovan EF, McDonald SA, Poole WK; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Effects of delayed cord clamping in very-low-birth-weight infants. J Perinatol. 2011 Apr;31 Suppl 1(Suppl 1):S68-71. doi: 10.1038/jp.2010.186.
PubMed 21448208Rabe H, Wacker A, Hulskamp G, Hornig-Franz I, Schulze-Everding A, Harms E, Cirkel U, Louwen F, Witteler R, Schneider HP. A randomised controlled trial of delayed cord clamping in very low birth weight preterm infants. Eur J Pediatr. 2000 Oct;159(10):775-7. doi: 10.1007/pl00008345.
PubMed 11039135Strauss RG, Mock DM, Johnson KJ, Cress GA, Burmeister LF, Zimmerman MB, Bell EF, Rijhsinghani A. A randomized clinical trial comparing immediate versus delayed clamping of the umbilical cord in preterm infants: short-term clinical and laboratory endpoints. Transfusion. 2008 Apr;48(4):658-65. doi: 10.1111/j.1537-2995.2007.01589.x. Epub 2008 Jan 10.
PubMed 18194383Aladangady N, McHugh S, Aitchison TC, Wardrop CA, Holland BM. Infants' blood volume in a controlled trial of placental transfusion at preterm delivery. Pediatrics. 2006 Jan;117(1):93-8. doi: 10.1542/peds.2004-1773.
PubMed 16396865Baenziger O, Stolkin F, Keel M, von Siebenthal K, Fauchere JC, Das Kundu S, Dietz V, Bucher HU, Wolf M. The influence of the timing of cord clamping on postnatal cerebral oxygenation in preterm neonates: a randomized, controlled trial. Pediatrics. 2007 Mar;119(3):455-9. doi: 10.1542/peds.2006-2725.
PubMed 17332197Hofmeyr GJ, Bolton KD, Bowen DC, Govan JJ. Periventricular/intraventricular haemorrhage and umbilical cord clamping. Findings and hypothesis. S Afr Med J. 1988 Jan 23;73(2):104-6.
PubMed 3340910Hofmeyr GJ, Gobetz L, Bex PJ, Van der Griendt M, Nikodem C, Skapinker R, Delahunt T. Periventricular/intraventricular hemorrhage following early and delayed umbilical cord clamping. A randomized controlled trial. Online J Curr Clin Trials. 1993 Dec 29;Doc No 110:[2002 words; 26 paragraphs].
PubMed 8305996Kinmond S, Aitchison TC, Holland BM, Jones JG, Turner TL, Wardrop CA. Umbilical cord clamping and preterm infants: a randomised trial. BMJ. 1993 Jan 16;306(6871):172-5. doi: 10.1136/bmj.306.6871.172.
PubMed 8443480McDonnell M, Henderson-Smart DJ. Delayed umbilical cord clamping in preterm infants: a feasibility study. J Paediatr Child Health. 1997 Aug;33(4):308-10. doi: 10.1111/j.1440-1754.1997.tb01606.x.
PubMed 9323618Committee on Obstetric Practice, American College of Obstetricians and Gynecologists. Committee Opinion No.543: Timing of umbilical cord clamping after birth. Obstet Gynecol. 2012 Dec;120(6):1522-6. doi: 10.1097/01.AOG.0000423817.47165.48.
PubMed 23168790
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Delayed Cord Clamping on Postnatal Circulatory Status in Preterm Neonates
- ClinicalTrials.gov ID
- NCT02478684
- Acronym / sponsor ID
- DCC / 1411015633
- Conditions
- Premature Birth of Newborn, Infant, Very Low Birth Weight, Delayed Separation of Umbilical Cord, Placental Transfusion
- Keywords
- delayed cord clamping, premature infants, randomized study, hematocrit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 23 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Delayed cord clamping (DCC) from 30 to 60 seconds allows blood to continue to flow from the placenta through the umbilical cord to the infant, thus resulting in a placental transfusion. This transfusion may improve circulating volume at birth leading to a smoother postnatal transition and overall improved outcome for preterm infants. The average blood volume delivered with DCC up to 90 seconds in preterm infants has been estimated to be about 12 ml per kg with vaginal deliveries resulting in slightly higher transfusions compared to cesarean deliveries. Several several short-term benefits have been described including a reduction in the need for blood transfusions as well as a possible reduction in intraventricular hemorrhage and necrotizing enterocolitis. All mothers with threatened preterm delivery between 28 and 34 6/7 weeks will be approached for the study. Following consent, the infant will be randomly assigned to either a 30 or 60 second delay in cord clamping in the delivery room. If the infant is not breathing by 30 seconds, the cord will be clamped and the infant moved to a resuscitation area. The primary outcome is a 3 percent difference in the hematocrit at one hour (routinely obtained on all babies). With approximately 75 neonates in each group (30 and 60 second DCC), there is 80% power to detect a difference in the mean hematocrit of 3% using a two-sample t-test with a 0.05 two-sided significance level.
Detailed description
Placental transfusion at birth is thought to have immediate, short-term and long-term benefits for the neonate. Delaying cord clamping is thought to allow for a smoother postnatal transition as the necessary cardiopulmonary changes take place specifically when the infant establishes spontaneous respirations and/or experimentally when mechanical ventilation is initiated. By allowing the infant to establish respirations, the pulmonary vascular bed is able to relax prior to the removal of the low-resistance placental vascular bed, thus avoiding a reflexive bradycardia. A 2012 Cochrane review of DCC in preterm infants has suggested several short-term benefits including a reduction in the need for blood transfusions as well as a possible reduction in intraventricular hemorrhage and necrotizing enterocolitis. The American College of Obstetrics and Gynecology (ACOG) published a committee opinion in December of 2012 stating that current evidence supports delayed cord clamping in preterm infants. They go on to support that DCC up to 30-60 seconds has been shown to improve transitional circulation, decreased the need for blood transfusion, and may even reduce the incidence of intraventricular hemorrhage. The primary objective of this study is to determine if delayed cord clamping up to 60 seconds leads to an improved postnatal transition as demonstrated by higher initial hematocrit at 30 minutes in preterm neonates born between 28 and 34+6/7 weeks gestation. The investigators will determine whether there is a significant difference in this primary outcome with delays of 30 seconds versus 60 seconds. A secondary objective will be to determine the effect of DCC on additional measures such as Apgar scores, initial heart rate, initial temperature, blood pressure measures, fluid resuscitation and/or the need for pressors, peak bilirubin, and days on phototherapy.
Inclusion Criteria: Preterm infants born between 28 and 34+6/7 weeks gestation. Exclusion Criteria: Infant with suspected placental abruption, bleeding from placenta previa, terminal bradycardia, cord prolapse, meconium, or any major congenital anomalies.
All mothers with threatened preterm delivery between 28 and 34 6/7 weeks will be approached for the study. If consent is obtained, the infant will be randomly assigned to either a 30 or 60 second delay of cord clamping in the delivery room. All delivery room staff will be notified of the assignment prior to the delivery. The Neonatal Intensive Care Unit (NICU) staff will be present at each delivery, including a NICU Fellow, a NICU nurse, and/or an neonatal nurse practitioner or pediatric resident. In the case of a C-Section, the NICU fellow will be in sterile gown and gloves in order to assess the infant on the sterile field. The timer will start immediately following delivery of the entire infant. In the case of a vaginal delivery the infant will be placed between the mother's legs or on the mother's abdomen in the case of a cesarean section. The fellow will evaluate the infant to assess onset of respirations while stimulating and covering the infant in a plastic wrap. If the infant has good tone and sustained breathing, the umbilical cord will continue to be unclamped though a maximum of 60 seconds. If the infant has not begun to establish respirations at 30 seconds, the cord will be clamped and the infant will be transferred to the radiant warmer regardless of their original assignment.
The primary outcome is a 3 percent difference in the hematocrit at one hour (routinely obtained on all babies). With approximately 75 neonates in each group (30 and 60 second DCC), there is 80% power to detect a difference in the mean hematocrit of 3% using a two-sample t-test with a 0.05 two-sided significance level.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 30 seconds of DCC | Active comparator | Other: 30 Seconds of placental blood transfusion30 Seconds of placental blood transfusion |
| 60 seconds DCC | Active comparator | Other: 60 Seconds of placental blood transfusion60 Seconds of placental blood transfusion |
Who may qualify
- Ages
- 28 to 35 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Premature infants between 28 and 34 6/7 weeks
- Parents have given informed consent
Key exclusion criteria (6 listed)
- Suspected placental abruption
- Bleeding from placenta previa
- Terminal bradycardia
- Cord prolapse
- Meconium
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 |
|---|---|---|
| 30 Seconds of placental blood transfusionAlso: 30 Seconds of Delayed Cord ClampingBy delaying clamping of the cord blood for 30 seconds, blood will be allowed to move from the placenta to the premature infant | Other | 30 seconds of DCC |
| 60 Seconds of placental blood transfusionAlso: 60 Seconds of Delayed Cord ClampingBy delaying clamping of the cord blood for 60 seconds, blood will be allowed to move from the placenta to the premature infant | Other | 60 seconds DCC |
Primary outcome
Measurement of Hematocrit at one hour of life
Time frame: 18 months
There should be a 3% difference between the 30 second and 60 second arms.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
- Background: PubMed 17516307Kugelman A, Borenstein-Levin L, Riskin A, Chistyakov I, Ohel G, Gonen R, Bader D. Immediate versus delayed umbilical cord clamping in premature neonates born < 35 weeks: a prospective, randomized, controlled study. Am J Perinatol. 2007 May;24(5):307-15. doi: 10.1055/s-2007-981434. Epub 2007 May 21.
- Background: PubMed 13679933Mercer JS, McGrath MM, Hensman A, Silver H, Oh W. Immediate and delayed cord clamping in infants born between 24 and 32 weeks: a pilot randomized controlled trial. J Perinatol. 2003 Sep;23(6):466-72. doi: 10.1038/sj.jp.7210970.
- Background: PubMed 16585320Mercer JS, Vohr BR, McGrath MM, Padbury JF, Wallach M, Oh W. Delayed cord clamping in very preterm infants reduces the incidence of intraventricular hemorrhage and late-onset sepsis: a randomized, controlled trial. Pediatrics. 2006 Apr;117(4):1235-42. doi: 10.1542/peds.2005-1706.
- Background: PubMed 21448208Oh W, Fanaroff AA, Carlo WA, Donovan EF, McDonald SA, Poole WK; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Effects of delayed cord clamping in very-low-birth-weight infants. J Perinatol. 2011 Apr;31 Suppl 1(Suppl 1):S68-71. doi: 10.1038/jp.2010.186.
- Background: PubMed 11039135Rabe H, Wacker A, Hulskamp G, Hornig-Franz I, Schulze-Everding A, Harms E, Cirkel U, Louwen F, Witteler R, Schneider HP. A randomised controlled trial of delayed cord clamping in very low birth weight preterm infants. Eur J Pediatr. 2000 Oct;159(10):775-7. doi: 10.1007/pl00008345.
- Background: PubMed 18194383Strauss RG, Mock DM, Johnson KJ, Cress GA, Burmeister LF, Zimmerman MB, Bell EF, Rijhsinghani A. A randomized clinical trial comparing immediate versus delayed clamping of the umbilical cord in preterm infants: short-term clinical and laboratory endpoints. Transfusion. 2008 Apr;48(4):658-65. doi: 10.1111/j.1537-2995.2007.01589.x. Epub 2008 Jan 10.
- Background: PubMed 16396865Aladangady N, McHugh S, Aitchison TC, Wardrop CA, Holland BM. Infants' blood volume in a controlled trial of placental transfusion at preterm delivery. Pediatrics. 2006 Jan;117(1):93-8. doi: 10.1542/peds.2004-1773.
- Background: PubMed 17332197Baenziger O, Stolkin F, Keel M, von Siebenthal K, Fauchere JC, Das Kundu S, Dietz V, Bucher HU, Wolf M. The influence of the timing of cord clamping on postnatal cerebral oxygenation in preterm neonates: a randomized, controlled trial. Pediatrics. 2007 Mar;119(3):455-9. doi: 10.1542/peds.2006-2725.
- Background: PubMed 3340910Hofmeyr GJ, Bolton KD, Bowen DC, Govan JJ. Periventricular/intraventricular haemorrhage and umbilical cord clamping. Findings and hypothesis. S Afr Med J. 1988 Jan 23;73(2):104-6.
- Background: PubMed 8305996Hofmeyr GJ, Gobetz L, Bex PJ, Van der Griendt M, Nikodem C, Skapinker R, Delahunt T. Periventricular/intraventricular hemorrhage following early and delayed umbilical cord clamping. A randomized controlled trial. Online J Curr Clin Trials. 1993 Dec 29;Doc No 110:[2002 words; 26 paragraphs].
- Background: PubMed 8443480Kinmond S, Aitchison TC, Holland BM, Jones JG, Turner TL, Wardrop CA. Umbilical cord clamping and preterm infants: a randomised trial. BMJ. 1993 Jan 16;306(6871):172-5. doi: 10.1136/bmj.306.6871.172.
- Background: PubMed 9323618McDonnell M, Henderson-Smart DJ. Delayed umbilical cord clamping in preterm infants: a feasibility study. J Paediatr Child Health. 1997 Aug;33(4):308-10. doi: 10.1111/j.1440-1754.1997.tb01606.x.
- Individual participant dataSharing planned: No
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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.
Jeffrey Perlman, MB Ch B principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 30 Seconds of placental blood transfusion and 60 Seconds of placental blood transfusion in people with Premature Birth of Newborn and Infant, Very Low Birth Weight, run by Weill Medical College of Cornell University 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 2 inclusion and 6 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 30 Oct 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measurement of Hematocrit at one hour of life (time frame: 18 months). 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 NCT02478684, which also lists 13 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 30 Oct 2019.