NCT01753843

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 20, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

July 8, 2013

Status Verified

July 1, 2013

Enrollment Period

1 year

First QC Date

December 18, 2012

Last Update Submit

July 4, 2013

Conditions

Preterm Birth

Keywords

Preterm Birth

Outcome Measures

Primary Outcomes (1)

  • short term neurobehavioral outcome

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

    at 37 weeks post conceptional age

Secondary Outcomes (1)

  • measuring cord hematocrit

    at birth

Study Arms (2)

early cord clamping

ACTIVE COMPARATOR

cord clamping within 20 sec

Procedure: early cord clamping

brief delay in cord clamping

EXPERIMENTAL

cord clamping delayed by 30 to 60 seconds

Procedure: Brief Delay in cord clamping

Interventions

early cord clampingPROCEDURE

early ( \<20 seconds)

early cord clamping
Brief Delay in cord clampingPROCEDURE

delay in cord clamping 30 to 60 seconds

brief delay in cord clamping

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Fetus with gross congenital anomaly
  • Fetus with hydrops
  • Rh negative pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lady Hardinge Medical College

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

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Vikram Datta, M.D.

    Lady Hardinge Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 18, 2012

First Posted

December 20, 2012

Study Start

July 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

July 8, 2013

Record last verified: 2013-07

Locations

IN(1)