Brief Delay in Cord Clamping and Neurobehaviour in Preterms
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|ClinicalTrials.gov Identifier: NCT01753843|
Recruitment Status : Completed
First Posted : December 20, 2012
Last Update Posted : July 8, 2013
|Condition or disease||Intervention/treatment||Phase|
|Preterm Birth||Procedure: early cord clamping Procedure: Brief Delay in cord clamping||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- short term neurobehavioral outcome [ Time Frame: at 37 weeks post conceptional age ]using N.A.P.I (neurobehavioural assessment of preterm infant)
- measuring cord hematocrit [ Time Frame: at birth ]
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 ClinicalTrials.gov identifier (NCT number): NCT01753843
|Lady Hardinge Medical College|
|New Delhi, Delhi, India, 110001|
|Principal Investigator:||Vikram Datta, M.D.||Lady Hardinge Medical College, New Delhi|