A randomized, double-blind trial of oral sucrose and placebo for pain relief in retinopathy of prematurity examinatio

Not Applicable

Recruiting

• Conditions: eonatal painRetinopathy of prematurity examination; N- PASS (Neonatal pain, agitation, and sedation scale); Preterm infants; Retinopathy of prematurity examination

• Registration Number: TCTR20160603001
• Lead Sponsor: Phramongkutklao College of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-03
• Study Completion: 2017-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.Infants with birth weight ≤ 1500 g or
2.Infants with gestational age at birth≤32 weeks or
3.Selected infants with a birth weight between 1500 and 2000 g or gestational age of more than 32 weeks with an unstable clinical course, including those requiring cardiorespiratory support and who are believed by their attending pediatrician or neonatologist to be at high-risk

Exclusion Criteria

1.Infant requiring mechanical ventilation or oxygen supplementation
2.Infants with congenital malformations
3.Infant receiving sedation
4.Infants where consent to participate was not obtained from parents

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain scores by N-PASS (Neonatal pain, agitation, and sedation scale) During first eye ROP examination ( about 2 minutes ) Observation. Pain is scored from 0 to 2 for each behavioral and physiological criteria , then summed

Secondary Outcome Measures

Name	Time	Method
ROP staging During ROP exam ( 5 minutes ) Examination and observation,Oxygen saturation before and during ROP examination and its treatment During ROP exam ( 5 minutes ) Observation,Event of apnea and its treatment During ROP exam ( 5 minutes Observation