Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-02-25 @ 6:30 PM
Study NCT ID:
NCT01552993
Status:
TERMINATED
Last Update Posted:
2016-04-22
First Post:
2012-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registration and Treatment of Pain During Eye Examination of Prematurity
Sponsor:
St. Olavs Hospital
Organization:
Study Overview
Official Title:
Registration and Treatment of Pain During Eye Examination of Prematurity
Status:
TERMINATED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
the chosen intervention was obviously ineffective
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to see if paracetamol has a pain-relieving effect during eye examination in premature infants.
Detailed Description:
Retinopathy of prematurity (ROP) is a feared complication of premature birth. If discovered in time, the disease can be treated, and impaired vision or blindness can be reduced. Premature infants are therefore examined regularly after birth. However, the examination is painful and stressful for the infant. Painful experiences might lead to a pathological stress response later in life and should therefore be prevented.
This is a double blinded, controlled and randomized study where the infants are examined and assessed either with or without the use of paracetamol.
This is a double blinded, controlled and randomized study where the infants are examined and assessed either with or without the use of paracetamol.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: