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
  Purpose

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 Intervention
Preterm Birth
Procedure: early cord clamping
Procedure: Brief Delay in cord clamping

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Lady Hardinge Medical College:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • measuring cord hematocrit [ Time Frame: at birth ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: July 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753843

Locations
India
Lady Hardinge Medical College
New Delhi, Delhi, India, 110001
Sponsors and Collaborators
Lady Hardinge Medical College
Investigators
Principal Investigator: Vikram Datta, M.D. lady hardinge medical college new delhi
  More Information

No publications provided

Responsible Party: DR. VIKRAM DATTA, Principal Investigator, Lady Hardinge Medical College
ClinicalTrials.gov Identifier: NCT01753843     History of Changes
Other Study ID Numbers: Brief Delay in Cord Clamping
Study First Received: December 18, 2012
Last Updated: July 4, 2013
Health Authority: India: Institutional Review Board

Keywords provided by Lady Hardinge Medical College:
Preterm Birth

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

ClinicalTrials.gov processed this record on April 22, 2014