Brief Delay in Cord Clamping and Neurobehaviour in Preterms

NCT ID: NCT01753843

Last Updated: 2013-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-07-31

Brief Summary

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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

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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.ยน
* 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

Conditions

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Preterm Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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early cord clamping

cord clamping within 20 sec

Group Type ACTIVE_COMPARATOR

early cord clamping

Intervention Type PROCEDURE

early ( \<20 seconds)

brief delay in cord clamping

cord clamping delayed by 30 to 60 seconds

Group Type EXPERIMENTAL

Brief Delay in cord clamping

Intervention Type PROCEDURE

delay in cord clamping 30 to 60 seconds

Interventions

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early cord clamping

early ( \<20 seconds)

Intervention Type PROCEDURE

Brief Delay in cord clamping

delay in cord clamping 30 to 60 seconds

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lady Hardinge Medical College

OTHER_GOV

Sponsor Role lead

Responsible Party

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DR. VIKRAM DATTA

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vikram Datta, M.D.

Role: PRINCIPAL_INVESTIGATOR

Lady Hardinge Medical College

Locations

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Lady Hardinge Medical College

New Delhi, National Capital Territory of Delhi, India

Site Status

Countries

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India

Other Identifiers

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Brief Delay in Cord Clamping

Identifier Type: -

Identifier Source: org_study_id

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