Brief Delay in Cord Clamping and Neurobehaviour in Preterms

Lady Hardinge Medical College

Status: Completed

Conditions: Preterm Birth

Treatments: Procedure: early cord clamping; Procedure: Brief Delay in cord clamping

Study type: Interventional

Funder types: Other

Identifiers

NCT01753843

Brief Delay in Cord Clamping

Details and patient eligibility

About

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

Full 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

Enrollment: 120 patients

Sex: All

Volunteers: Accepts 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

early cord clamping

Active Comparator group

Description:

cord clamping within 20 sec

Treatment:

Procedure: early cord clamping

brief delay in cord clamping

Experimental group

Description:

cord clamping delayed by 30 to 60 seconds

Treatment:

Procedure: Brief Delay in cord clamping