Brief Delay in Cord Clamping and Neurobehaviour in Preterms

A Randomised Controlled Trial to Evaluate the Role of Brief Delay in Cord Clamping in Preterm Neonates (34-36weeks) on Short Term Neurodevelopmental Outcome

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01753843

Enrollment

120

Registered

2012-12-20

Start date

2012-07-31

Completion date

2013-07-31

Last updated

2013-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Birth

Keywords

Preterm Birth

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

Interventions

PROCEDUREearly cord clamping

early ( \<20 seconds)

PROCEDUREBrief Delay in cord clamping

delay in cord clamping 30 to 60 seconds

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
measuring cord hematocrit	at birth

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026