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Feeling of pain to pinpricks in small babies

Not Applicable
Completed
Conditions
Health Condition 1: R448- Other symptoms and signs involvinggeneral sensations and perceptions
Registration Number
CTRI/2021/03/031863
Lead Sponsor
All India Institute of Medical Sciences Rishikesh
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
180
Inclusion Criteria

Clinically stable neonates of gestational age >=28+0 weeks and birth weight >800g, requiring heel prick for blood sampling, during the first week of life

Exclusion Criteria

1.Neonatal encephalopathy

2.Major intraventricular hemorrhage (grade III or IV) or other abnormality documented in cranial ultrasonography

3.Hemodynamic instability/shock

4. Patent ductus arteriosus

5. Mechanical ventilation

6. Major congenital malformations

7. Sedation or analgesia

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Premature infant pain profile - Revised (PIPP-R) score during heel prickTimepoint: At the time of heel prick for blood sampling during first week of life
Secondary Outcome Measures
NameTimeMethod
1.Changes in cerebral oxygenation (CrSO2) in near infra-red spectrometry values during procedure. <br/ ><br>2.Duration of audible cry <br/ ><br>3.Correlation of CrSO2 values with PIPP-R scores obtained in the study. <br/ ><br>4.Difficulties encountered during the procedure (number of squeezes and pricks required for adequate sampling) and procedure related complications (bruising, inflammation and linear scar formation) <br/ ><br>Timepoint: At the time of heel prick for blood sampling during first week of life
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