Brief Delay in Cord Clamping and Neurobehaviour in Preterms

July 4, 2013 updated by: DR. VIKRAM DATTA, Lady Hardinge Medical College

A Randomised Controlled Trial to Evaluate the Role of Brief Delay in Cord Clamping in Preterm Neonates (34-36weeks) on Short Term Neurodevelopmental Outcome

RESEARCH HYPOTHESIS Brief delay(>30 sec to <60 sec ) in cord clamping as compared to early cord clamping (< 20 sec) leads to a better short term neurobehavioural outcome in preterm (34-36 wks) neonates when assessed by neurobehavioral assessment of preterm infants (n.a.p.i.) at 37 weeks of post conceptional age

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Delayed cord clamping (DCC) : Well described phenomenon in term infants .

  • The optimal timing of clamping of umbilical cord in preterm infants : A subject of debate.
  • Even a brief delay in cord clamping leads to an additional transfer of iron amounting to 40-50 mg/kg which may prevent iron deficiency.¹
  • This low cost intervention can have significant public health importance in resource constrained settings.
  • The effect of this intervention on neurobehaviour of preterm neonates has not been assessed.
  • This aspect has been identified by WHO and Cochrane as a potentially researchable area

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • 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

  • India
    • Delhi
      • New Delhi, Delhi, India, 110001
        • Lady Hardinge Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All preterm deliveries -infants born at 34 weeks 0 days to 36 weeks +6 days gestational age as estimated by last menstrual period or early ultrasound scan.
  • Infants delivered vaginally or by caesarean section in cephalic presentation
  • Singleton pregnancy
  • Parental consent

Exclusion Criteria:

  • Fetus with gross congenital anomaly
  • Fetus with hydrops
  • Rh negative pregnancy

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: early cord clamping
cord clamping within 20 sec
Procedure: early cord clamping
early ( <20 seconds)
Experimental: brief delay in cord clamping
cord clamping delayed by 30 to 60 seconds
Procedure: Brief Delay in cord clamping
delay in cord clamping 30 to 60 seconds

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
short term neurobehavioral outcome
Time Frame: at 37 weeks post conceptional age
using N.A.P.I (neurobehavioural assessment of preterm infant)
at 37 weeks post conceptional age

Secondary Outcome Measures

Outcome Measure
Time Frame
measuring cord hematocrit
Time Frame: at birth
at birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lady Hardinge Medical College

Investigators

  • Principal Investigator: Vikram Datta, M.D., Lady Hardinge Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

December 18, 2012

First Submitted That Met QC Criteria

December 18, 2012

First Posted (Estimate)

December 20, 2012

Study Record Updates

Last Update Posted (Estimate)

July 8, 2013

Last Update Submitted That Met QC Criteria

July 4, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Brief Delay in Cord Clamping

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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