NCT02231411

Brief Summary

The purpose of this study is to examine whether providing ventilation during delayed umbilical cord clamping provides greater placental transfusion and improved hemodynamic transition at birth.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2014

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 4, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

2 years

First QC Date

August 11, 2014

Last Update Submit

May 24, 2017

Conditions

Intraventricular Hemorrhage

Keywords

Delayed Cord ClampingPulmonary Ventilation

Outcome Measures

Primary Outcomes (1)

  • Peak Hematocrit

    within 24 hours

Secondary Outcomes (40)

  • Maximum inspired oxygen (FiO2) (percentage)

    over the first 5 minutes of life

  • Positive Pressure Ventilation given

    1 minute

  • DR interventions after delayed cord clamping complete

    10 minutes of life

  • Maximum Peak Inspiratory Pressure (cm H2O)

    over the first 5 minutes of life

  • Time to reach heart rate >100 beats per minute (seconds)

    over the first 5 minutes of life

  • +35 more secondary outcomes

Study Arms (2)

Ventilation during DCC (V-DCC)

ACTIVE COMPARATOR

Measuring the volume of placental transfusion with ventilation (CPAP 5 cm H2O between inflations) in infants born by C/S or VG using, as an initial surrogate marker, Hematocrits at 12 hours of life (HOL)

Procedure: V-DCC

DCC plus dry and stimulate

ACTIVE COMPARATOR

Measuring the volume of placental transfusions with delayed cord clamping alone (DCC) in infants born by C/S or VD using, as an initial surrogate marker, Hematocrits at 12 hours of life (HOL)

Procedure: Delayed cord clampingProcedure: Dry and and if apneic initially can stimulate by gently rubbing the back for approximately 30 seconds with warm sterile towels

Interventions

V-DCCPROCEDURE

Ventilation with CPAP 5 cm H2O between inflations and Delayed clamping of the umbilical cord for 60 seconds

Ventilation during DCC (V-DCC)
Delayed cord clampingPROCEDURE

Delayed clamping of the umbilical cord for 60 seconds

DCC plus dry and stimulate
Dry and and if apneic initially can stimulate by gently rubbing the back for approximately 30 seconds with warm sterile towelsPROCEDURE
DCC plus dry and stimulate

Eligibility Criteria

Age23 Weeks - 31 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Gestational Age: Women admitted 23+0 to 31+6 weeks (Reason: Highest risk for IVH)

You may not qualify if:

  • Gestational Age: Parents decline consent (Reason: Can only perform intervention at time of delivery)
  • Congenital anomalies of newborn (Reason: Exclude the effect of abnormal hematological function)
  • Placental abruption (Reason: Exclude pregnancies at risk for hemorrhage at the time of delivery)
  • Twin to twin transfusion (Reason: Exclude possible loss of blood from other twin during delayed cord clamping)
  • Placenta Accreta
  • Prolonged premature rupture of membranes (\> 2 weeks) prior to 23 weeks gestation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sharp Mary Birch Hospital for Women and Newborns

San Diego, California, 92123, United States

Location

Related Publications (1)

  • Katheria A, Poeltler D, Durham J, Steen J, Rich W, Arnell K, Maldonado M, Cousins L, Finer N. Neonatal Resuscitation with an Intact Cord: A Randomized Clinical Trial. J Pediatr. 2016 Nov;178:75-80.e3. doi: 10.1016/j.jpeds.2016.07.053. Epub 2016 Aug 26.

    PMID: 27574999DERIVED

MeSH Terms

Interventions

Umbilical Cord ClampingDesiccation

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, OperativeChemistry Techniques, AnalyticalInvestigative TechniquesChemical Phenomena

Study Officials

  • Anup C Katheria, MD

    Sharp HealthCare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Neonatal Research Institute

Study Record Dates

First Submitted

August 11, 2014

First Posted

September 4, 2014

Study Start

August 1, 2014

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

May 30, 2017

Record last verified: 2017-05

Locations

US(1)