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Delayed Cord Clamping in Preterm Neonates (DCC)

Primary Purpose

Premature Birth of Newborn, Infant, Very Low Birth Weight, Delayed Separation of Umbilical Cord

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
30 Seconds of placental blood transfusion
60 Seconds of placental blood transfusion
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Premature Birth of Newborn focused on measuring delayed cord clamping, premature infants, randomized study, hematocrit

Eligibility Criteria

28 Weeks - 35 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Premature infants between 28 and 34 6/7 weeks
  • Parents have given informed consent

Exclusion Criteria:

  • Suspected placental abruption
  • Bleeding from placenta previa
  • Terminal bradycardia
  • Cord prolapse
  • Meconium
  • Any major congenital anomalies

Sites / Locations

  • Weill Cornell medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

30 seconds of DCC

60 seconds DCC

Arm Description

30 Seconds of placental blood transfusion

60 Seconds of placental blood transfusion

Outcomes

Primary Outcome Measures

Measurement of Hematocrit at one hour of life
There should be a 3% difference between the 30 second and 60 second arms.

Secondary Outcome Measures

Full Information

First Posted
June 11, 2015
Last Updated
October 28, 2019
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT02478684
Brief Title
Delayed Cord Clamping in Preterm Neonates
Acronym
DCC
Official Title
The Effects of Delayed Cord Clamping on Postnatal Circulatory Status in Preterm Neonates
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
March 30, 2019 (Actual)
Study Completion Date
March 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
30 seconds of DCC
Arm Type
Active Comparator
Arm Description
30 Seconds of placental blood transfusion
Arm Title
60 seconds DCC
Arm Type
Active Comparator
Arm Description
60 Seconds of placental blood transfusion
Intervention Type
Other
Intervention Name(s)
30 Seconds of placental blood transfusion
Other Intervention Name(s)
30 Seconds of Delayed Cord Clamping
Intervention Description
By delaying clamping of the cord blood for 30 seconds, blood will be allowed to move from the placenta to the premature infant
Intervention Type
Other
Intervention Name(s)
60 Seconds of placental blood transfusion
Other Intervention Name(s)
60 Seconds of Delayed Cord Clamping
Intervention Description
By delaying clamping of the cord blood for 60 seconds, blood will be allowed to move from the placenta to the premature infant
Primary Outcome Measure Information:
Title
Measurement of Hematocrit at one hour of life
Description
There should be a 3% difference between the 30 second and 60 second arms.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
28 Weeks
Maximum Age & Unit of Time
35 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Premature infants between 28 and 34 6/7 weeks Parents have given informed consent Exclusion Criteria: Suspected placental abruption Bleeding from placenta previa Terminal bradycardia Cord prolapse Meconium Any major congenital anomalies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Perlman, MB Ch B
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17516307
Citation
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.
Results Reference
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Citation
Mercer 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.
Results Reference
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PubMed Identifier
16585320
Citation
Mercer 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.
Results Reference
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PubMed Identifier
21448208
Citation
Oh 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.
Results Reference
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PubMed Identifier
11039135
Citation
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Results Reference
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PubMed Identifier
18194383
Citation
Strauss 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.
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PubMed Identifier
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Citation
Aladangady 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.
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PubMed Identifier
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Citation
Baenziger 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.
Results Reference
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PubMed Identifier
3340910
Citation
Hofmeyr 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.
Results Reference
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PubMed Identifier
8305996
Citation
Hofmeyr 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].
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Citation
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Citation
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Citation
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Results Reference
result

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Delayed Cord Clamping in Preterm Neonates

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