Delayed Cord Clamping in Preterm Neonates

NCT02478684 | Completed DMC

• 1 other identifier: 1411015633
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Measurement of Hematocrit at one hour of life

  There should be a 3% difference between the 30 second and 60 second arms.

  18 months

Study Arms (2)

30 seconds of DCC

ACTIVE COMPARATOR

30 Seconds of placental blood transfusion

Other: 30 Seconds of placental blood transfusion

60 seconds DCC

ACTIVE COMPARATOR

60 Seconds of placental blood transfusion

Other: 60 Seconds of placental blood transfusion

Interventions

30 Seconds of placental blood transfusion OTHER

By delaying clamping of the cord blood for 30 seconds, blood will be allowed to move from the placenta to the premature infant

Also known as: 30 Seconds of Delayed Cord Clamping

30 seconds of DCC

60 Seconds of placental blood transfusion OTHER

By delaying clamping of the cord blood for 60 seconds, blood will be allowed to move from the placenta to the premature infant

Also known as: 60 Seconds of Delayed Cord Clamping

60 seconds DCC

Eligibility Criteria

• Age: 28 Weeks - 35 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell medical College

New York, New York, 10065, United States

Location

Related Publications (13)

• 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.

  PMID: 17516307 BACKGROUND

• 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.

  PMID: 13679933 BACKGROUND

• 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.

  PMID: 16585320 BACKGROUND

• 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.

  PMID: 21448208 BACKGROUND

• Rabe 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.

  PMID: 11039135 BACKGROUND

• 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.

  PMID: 18194383 BACKGROUND

• 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.

  PMID: 16396865 BACKGROUND

• 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.

  PMID: 17332197 BACKGROUND

• 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.

  PMID: 3340910 BACKGROUND

• 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].

  PMID: 8305996 BACKGROUND

• Kinmond 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.

  PMID: 8443480 BACKGROUND

• McDonnell 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.

  PMID: 9323618 BACKGROUND

• Committee 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.

  PMID: 23168790 RESULT

MeSH Terms

Conditions

Premature Birth; Fetofetal Transfusion

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Anemia, Neonatal; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Jeffrey Perlman, MB Ch B

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2015
• First Posted: June 23, 2015
• Study Start: July 1, 2015
• Primary Completion: March 30, 2019
• Study Completion: March 30, 2019
• Last Updated: October 30, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)