A study to assess the pain relieving effects of Breast milk and a comparison of its effectiveness with that of sugar solution (oral sucrose) and a Placebo (Sterile water) in healthy newborns undergoing a painful procedure.
Not Applicable
- Registration Number
- CTRI/2024/07/071269
- Lead Sponsor
- Pranav Agrawal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All Clinically Stable Neonates of gestational age 35 weeks and above.
Exclusion Criteria
1. Perinatal Asphyxia
2. Birth trauma
3. Cardiorespiratory instability, suspected or confirmed sepsis or Necrotising Enterocolitis
4. Any Apparent CNS Anomalies
5. Any Previous surgery
6. Maternal use of opioids, sedatives, analgesics
7. NICU Graduates
8. Consent not obtained
9. Use of Paracetamol or any other analgesics in the baby
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the effectiveness of breastmilk in reducing procedural pain in neonatesTimepoint: at Baseline, 30 seconds post procedure, and 5 minutes post procedure
- Secondary Outcome Measures
Name Time Method Comparing the analgesic effects of the three interventionsTimepoint: 30 seconds post procedure, 5 minutes post procedure;Comparison of changes in NIPS Pain Scores and Physiological Parameters between the three interventionsTimepoint: 30 seconds post procedure, 5 minutes post procedure