Brief Delay in Cord Clamping and Neurobehaviour in Preterms

Not Applicable

Completed

• Conditions: Preterm Birth
• Interventions: Procedure: early cord clamping; Procedure: Brief Delay in cord clamping

• Registration Number: NCT01753843
• Lead Sponsor: Lady Hardinge Medical College

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

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-12-18
• Study First Submitted QC: 2012-12-18
• Study First Posted: 2012-12-20
• Status Verified: 2013-07
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Last Update Submitted: 2013-07-04
• Last Update Posted: 2013-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
early cord clamping	early cord clamping	cord clamping within 20 sec
brief delay in cord clamping	Brief Delay in cord clamping	cord clamping delayed by 30 to 60 seconds

Primary Outcome Measures

Name	Time	Method
short term neurobehavioral outcome	at 37 weeks post conceptional age	using N.A.P.I (neurobehavioural assessment of preterm infant)

Secondary Outcome Measures

Name	Time	Method
measuring cord hematocrit	at birth

Trial Locations

Locations (1)

Lady Hardinge Medical College; 🇮🇳 New Delhi, Delhi, India