Brief Delay in Cord Clamping and Neurobehaviour in Preterms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01753843
Recruitment Status : Completed
First Posted : December 20, 2012
Last Update Posted : July 8, 2013
Information provided by (Responsible Party):
DR. VIKRAM DATTA, 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

Condition or disease Intervention/treatment Phase
Preterm Birth Procedure: early cord clamping Procedure: Brief Delay in cord clamping Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Study Start Date : July 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Arm Intervention/treatment
Active Comparator: early cord clamping
cord clamping within 20 sec
Procedure: early cord clamping
early ( <20 seconds)

Experimental: brief delay in cord clamping
cord clamping delayed by 30 to 60 seconds
Procedure: Brief Delay in cord clamping
delay in cord clamping 30 to 60 seconds

Primary Outcome Measures :
  1. short term neurobehavioral outcome [ Time Frame: at 37 weeks post conceptional age ]
    using N.A.P.I (neurobehavioural assessment of preterm infant)

Secondary Outcome Measures :
  1. measuring cord hematocrit [ Time Frame: at birth ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01753843

Lady Hardinge Medical College
New Delhi, Delhi, India, 110001
Sponsors and Collaborators
Lady Hardinge Medical College
Principal Investigator: Vikram Datta, M.D. Lady Hardinge Medical College, New Delhi

Responsible Party: DR. VIKRAM DATTA, Principal Investigator, Lady Hardinge Medical College Identifier: NCT01753843     History of Changes
Other Study ID Numbers: Brief Delay in Cord Clamping
First Posted: December 20, 2012    Key Record Dates
Last Update Posted: July 8, 2013
Last Verified: July 2013

Keywords provided by DR. VIKRAM DATTA, Lady Hardinge Medical College:
Preterm Birth

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications