Short-Delay Cord Clamping Compared to Extended- Delay Cord Clamping in Term Neonates That Require Resuscitation.

NCT02827409 | Completed

• 1 other identifier: Term-NRIC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To determine whether performing extended delayed cord clamping in term neonates that require resuscitation improves early transition as compared to short-delayed cord clamping.

Conditions

Placental Transfusion

Keywords

Delayed cord clamping

Outcome Measures

Primary Outcomes (1)

• Cerebral tissue oxygenation

  The need for oxygen, positive pressure ventilation, intubation

  12 hours of life

Secondary Outcomes (14)

• Heart rate

  First 5 minutes of life

• Oxygen saturation

  over the first 5 minutes of life

• delivery room resuscitation

  at birth

• Blood pressure

  12 hours of life

• Hemoglobin

  First 5 minutes of life

Study Arms (2)

Short Delay Cord Clamping

ACTIVE COMPARATOR

Subject will have umbilical cord clamped and cut by 1 minute of life.

Procedure: Short Delay Cord Clamping

Extended Delay Cord Clamping

ACTIVE COMPARATOR

Subject will have umbilical cord clamped and cut after at least 5 minutes of delayed cord clamping. Duration of cord clamping after 5 minutes will depend on if the subject is breathing and/or if the cord has stopped pulsating

Procedure: Extended Delay Cord Clamping

Interventions

Short Delay Cord Clamping PROCEDURE

Delay cord clamping will occur for up to 1 minute. Subject will be placed on mother's abdomen for warmth and stimulation. If the subject is depressed they will be transferred to the radiant warmer for resuscitation.

Short Delay Cord Clamping

Extended Delay Cord Clamping PROCEDURE

Extended delay cord clamping will occur for at least 5 minutes and will continue until the subjects begins breathing and/or the cord stops pulsating. Subject will be placed on mother's abdomen for warmth and stimulation. If the subject is depressed they will be transferred to the LifeStart bed for resuscitation adjacent to the mother's bedside.

Extended Delay Cord Clamping

Eligibility Criteria

• Age: 37 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

Sponsors & Collaborators

• Anup Katheria, M.D.: lead

Study Sites (1)

Sharp Mary Birch Hospital for Women and Newborns

San Diego, California, 92123, United States

Location

Related Publications (1)

• Katheria AC, Brown MK, Faksh A, Hassen KO, Rich W, Lazarus D, Steen J, Daneshmand SS, Finer NN. Delayed Cord Clamping in Newborns Born at Term at Risk for Resuscitation: A Feasibility Randomized Clinical Trial. J Pediatr. 2017 Aug;187:313-317.e1. doi: 10.1016/j.jpeds.2017.04.033. Epub 2017 May 16.

  PMID: 28526223 DERIVED

MeSH Terms

Conditions

Fetofetal Transfusion

Condition Hierarchy (Ancestors)

Anemia, Neonatal; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Anup Katheria, MD

  Sharp HealthCare

  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 INVESTIGATOR
• PI Title: Director Neonatal Reseach Institute

Study Record Dates

• First Submitted: July 5, 2016
• First Posted: July 11, 2016
• Study Start: July 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 8, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)