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Completed

NCT Number: NCT01753843

Brief Delay in Cord Clamping and Neurobehaviour in Preterms

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

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Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lady Hardinge Medical College

New Delhi, National Capital Territory of Delhi, 110001, India

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early Cord Clamping

Procedure

early ( <20 seconds)

Brief Delay in cord clamping

Procedure

delay in cord clamping 30 to 60 seconds

Primary outcomes

  1. short term neurobehavioral outcome

    Time frame: at 37 weeks post conceptional age

    using N.A.P.I (neurobehavioural assessment of preterm infant)

Secondary outcomes

  1. measuring cord hematocrit

    Time frame: at birth

Sponsors and collaborators

Lead sponsor

Lady Hardinge Medical College

Other Gov

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 20, 2012
Registry last updated
Jul 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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