Status:
COMPLETED
Role of Repeated Painful Procedures in Preterm Neonates on Short Term Neurobehavioural Outcome
Lead Sponsor:
Lady Hardinge Medical College
Conditions:
Pain
Eligibility:
All Genders
1-28 years
Phase:
PHASE3
Brief Summary
Procedural pain in neonates is recently acknowledged entity and many studies on the use of pharmacological as well as non pharmacological interventions for alleviation of this pain have been done. Of ...
Detailed Description
DEFINITION OF PAIN - an unpleasant sensory and emotional experience with actual or potential damage or described in terms of such damage (note that the inability to communicate verbally or non verball...
Eligibility Criteria
Inclusion
- All preterms (more than equal to 32 weeks to less than 37 weeks)
- within first 48 hrs of post natal life
- Clinically stable from respiratory and hemodynamic point of view
- Parental consent
Exclusion
- neonates requiring ventilatory support
- neonates with any neurological impairment(HIE ,seizures)
- receiving opiates or born to mothers receiving opiates
- newborns who have received muscle relaxants ,sedatives or analgesics
- grade 3 or 4 IVH
- major congenital anomalies
- 5 mins apgar of less than 7
- Neonates undergoing any surgery
- Birth trauma
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT01190995
Start Date
July 1 2010
End Date
November 1 2011
Last Update
November 24 2011
Active Locations (2)
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1
Lady Hardinge Medical College
New Delhi, New Delhi, India, 110001
2
Lady Hardinge Medical College,New Delhi
Delhi, India