Brief Delay in Cord Clamping and Neurobehaviour in Preterms

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DR. VIKRAM DATTA, Lady Hardinge Medical College
ClinicalTrials.gov Identifier:
NCT01753843
First received: December 18, 2012
Last updated: July 4, 2013
Last verified: July 2013

December 18, 2012
July 4, 2013
July 2012
July 2013   (final data collection date for primary outcome measure)
short term neurobehavioral outcome [ Time Frame: at 37 weeks post conceptional age ] [ Designated as safety issue: No ]
using N.A.P.I (neurobehavioural assessment of preterm infant)
Same as current
Complete list of historical versions of study NCT01753843 on ClinicalTrials.gov Archive Site
measuring cord hematocrit [ Time Frame: at birth ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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

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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Preterm Birth
  • Procedure: early cord clamping
    early ( <20 seconds)
  • Procedure: Brief Delay in cord clamping
    delay in cord clamping 30 to 60 seconds
  • Active Comparator: early cord clamping
    cord clamping within 20 sec
    Intervention: Procedure: early cord clamping
  • Experimental: brief delay in cord clamping
    cord clamping delayed by 30 to 60 seconds
    Intervention: Procedure: Brief Delay in cord clamping
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01753843
Brief Delay in Cord Clamping
No
DR. VIKRAM DATTA, Lady Hardinge Medical College
Lady Hardinge Medical College
Not Provided
Principal Investigator: Vikram Datta, M.D. lady hardinge medical college new delhi
Lady Hardinge Medical College
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP