Brief Delay in Cord Clamping and Neurobehaviour in Preterms

Preterm Birth Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01753843
• Other study ID #: Brief Delay in Cord Clamping
• Status: Completed
• Phase: N/A
• First received: December 18, 2012
• Last updated: July 4, 2013
• Start date: July 2012
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: Lady Hardinge Medical College
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

Procedure:
• early cord clamping
early ( <20 seconds)
• Brief Delay in cord clamping
delay in cord clamping 30 to 60 seconds

Locations

Country	Name	City	State
India	Lady Hardinge Medical College	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Lady Hardinge Medical College

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	short term neurobehavioral outcome	using N.A.P.I (neurobehavioural assessment of preterm infant)	at 37 weeks post conceptional age	No
Secondary	measuring cord hematocrit		at birth	No