NCT01018576

Brief Summary

Delayed cord clamping has been shown to decrease the risk of bleeding in the brain of premature infants. However this procedure is not standard due to concerns that the premature infant will get too cold. In this study the investigators look at using a plastic covering and a chemical warmer to keep the small premature baby warm while waiting 30-60 seconds to clamp the umbilical cord.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

September 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2009

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 23, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

December 2, 2014

Status Verified

December 1, 2014

Enrollment Period

2 years

First QC Date

November 5, 2009

Last Update Submit

December 1, 2014

Conditions

HypothermiaAnemia

Keywords

delayed cord clampingpremature infantshypothermiaanemiaintraventricular hemorrhageAnemia in premature infants

Outcome Measures

Primary Outcomes (1)

  • Initial body temperature

    At birth

Secondary Outcomes (1)

  • Hematocrit at birth and 24 hours of age

    first day of life

Study Arms (1)

Delayed cord clamping

EXPERIMENTAL
Other: Delayed cord clamping

Interventions

Delayed cord clampingOTHER

Infants will be covered with plastic and placed on a chemical warmer at delivery and then clamping of the umbilical cord will be delayed for 30-60 seconds.

Delayed cord clamping

Eligibility Criteria

AgeUp to 1 Minute
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • premature infants at 24-28 completed weeks gestation at the time of delivery
  • informed consent obtained from parents prior to delivery

You may not qualify if:

  • multiple gestation (twins, triplets, etc)
  • prolonged fetal bradycardia
  • placental abruption or previa
  • maternal illness
  • major congenital anomalies
  • maternal fever in labor
  • fetal illness (e.g. isoimmune hemolysis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

HypothermiaAnemiaPremature Birth

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsHematologic DiseasesHemic and Lymphatic DiseasesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Mark A Underwood, MD

    UC Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2009

First Posted

November 23, 2009

Study Start

September 1, 2009

Primary Completion

September 1, 2011

Study Completion

March 1, 2012

Last Updated

December 2, 2014

Record last verified: 2014-12

Locations

US(1)