Delayed Cord Clamping in Preterm Neonates (DCC)

October 28, 2019 updated by: Weill Medical College of Cornell University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
105

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medical College

Participation Criteria

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Eligibility Criteria

Eligibility Criteria

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Ages Eligible for Study

6 months to 8 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

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Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 30 seconds of DCC
30 Seconds of placental blood transfusion
Other: 30 Seconds of placental blood transfusion
By delaying clamping of the cord blood for 30 seconds, blood will be allowed to move from the placenta to the premature infant
Other Names:
  • 30 Seconds of Delayed Cord Clamping
Active Comparator: 60 seconds DCC
60 Seconds of placental blood transfusion
Other: 60 Seconds of placental blood transfusion
By delaying clamping of the cord blood for 60 seconds, blood will be allowed to move from the placenta to the premature infant
Other Names:
  • 60 Seconds of Delayed Cord Clamping

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
18 months

Collaborators and Investigators

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Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Weill Medical College of Cornell University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jeffrey Perlman, MB Ch B, Weill Medical College of Cornell University

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

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July 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 11, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 23, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 30, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1411015633

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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