se of oral glucose as analgesic for newborn babies undergoing eye examinatio
Phase 1
Completed
- Conditions
- Health Condition 1: null- Neonates undergoing first ROP Screening
- Registration Number
- CTRI/2018/05/013639
- Lead Sponsor
- ONE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 26
Inclusion Criteria
All babies satisfying the unit ROP screening protocol and undergoing the screening procedure for the first time, will be included after getting a written consent from parents / caretakers.
Exclusion Criteria
1. Babies on mechanical ventilator
2. Babies already on study drugs for any other reason
3. Breastfeeding mother in methadone or other analgesics
4. Babies with ileostomy / colostomy.
5. Babies kept NPO for other medical / surgical illness
6. Congenital anomalies
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (i) To assess Pain score by PIPP at 1 min post procedure (As planned for Phase III trial) <br/ ><br>(ii) recruitment and retention rates. <br/ ><br>(ii)Staff capacity to recruit and familiarity for randomisation procedures. <br/ ><br>(iii) availability of equipments and back up. <br/ ><br>(iv)estimate of effect size and use for sample size calculation for main study.Timepoint: (i) To assess Pain score by PIPP at 1 min post procedure <br/ ><br>(ii) recruitment and retention rates. <br/ ><br>(ii)Staff capacity to recruit and familiarity for randomisation procedures. <br/ ><br>(iii) availability of equipments and back up. <br/ ><br>(iv)estimate of effect size and use for sample size calculation for main study.
- Secondary Outcome Measures
Name Time Method (i) Pain scores a <br/ ><br>â?? 5min after procedure <br/ ><br>- 15min after procedure. <br/ ><br>- 30 min post procedure <br/ ><br>(ii) Adverse events - will be recorded in both groups.Tachycardia 180/min, Apnea, Abdominal distention, feed intolerance, increase in respiratory support - increase in Fio2 increase by 20%, flow increase by 10%, increase in PEEP by 1 , requiring new respiratory support or mechanical ventilation for 24 hours.Timepoint: 5min, 15 min and 30 min post procedure and monitor for 24 hours for adverse events