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Brief Delay in Cord Clamping and Neurobehaviour in Preterms

Primary Purpose

Preterm Birth

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
early cord clamping
Brief Delay in cord clamping
Sponsored by
Lady Hardinge Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Preterm Birth focused on measuring Preterm Birth

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Lady Hardinge Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

early cord clamping

brief delay in cord clamping

Arm Description

cord clamping within 20 sec

cord clamping delayed by 30 to 60 seconds

Outcomes

Primary Outcome Measures

short term neurobehavioral outcome
using N.A.P.I (neurobehavioural assessment of preterm infant)

Secondary Outcome Measures

measuring cord hematocrit

Full Information

First Posted
December 18, 2012
Last Updated
July 4, 2013
Sponsor
Lady Hardinge Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT01753843
Brief Title
Brief Delay in Cord Clamping and Neurobehaviour in Preterms
Official Title
A Randomised Controlled Trial to Evaluate the Role of Brief Delay in Cord Clamping in Preterm Neonates (34-36weeks) on Short Term Neurodevelopmental Outcome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lady Hardinge Medical College

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth
Keywords
Preterm Birth

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
early cord clamping
Arm Type
Active Comparator
Arm Description
cord clamping within 20 sec
Arm Title
brief delay in cord clamping
Arm Type
Experimental
Arm Description
cord clamping delayed by 30 to 60 seconds
Intervention Type
Procedure
Intervention Name(s)
early cord clamping
Intervention Description
early ( <20 seconds)
Intervention Type
Procedure
Intervention Name(s)
Brief Delay in cord clamping
Intervention Description
delay in cord clamping 30 to 60 seconds
Primary Outcome Measure Information:
Title
short term neurobehavioral outcome
Description
using N.A.P.I (neurobehavioural assessment of preterm infant)
Time Frame
at 37 weeks post conceptional age
Secondary Outcome Measure Information:
Title
measuring cord hematocrit
Time Frame
at birth

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vikram Datta, M.D.
Organizational Affiliation
Lady Hardinge Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lady Hardinge Medical College
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110001
Country
India

12. IPD Sharing Statement

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Brief Delay in Cord Clamping and Neurobehaviour in Preterms

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