Registration and Treatment of Pain During Eye Examination... | NCT01552993

Studies
Registration and Treatment of Pain During Eye Examination of Prematurity

NCT01552993

Sponsor

St. Olavs Hospital

Status

Terminated

Last Update Posted

Apr 22, 2016Estimated

Enrollment

5Actual

Phase

Not Applicable

Conditions

Infant, Premature
Retinopathy

Interventions

paracetamol
sucrose

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

the chosen intervention was obviously ineffective

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Oct 2012Actual

Completion Date

Oct 2012Actual

First Submitted Date

Mar 2, 2012

First Submission Date that Met QC Criteria

Mar 9, 2012

First Posted Date

Mar 13, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2016

Last Update Posted Date

Apr 22, 2016Estimated

Name	Class
Norwegian University of Science and Technology	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
paracetamol	Experimental	Paracetamol mixture 20 mg/kg + pacifier and sucrose	Drug: paracetamol
placebo	Placebo Comparator	pacifier and sucrose only	Drug: sucrose

Interventions

Name	Type	Description	Arm Group Labels	Other Names
paracetamol	Drug	Paracetamol mixture 20 mg/kg + pacifier and glucose	paracetamol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pain	Premature Infant Pain Profile (PIPP): score range 0-21. Used independently by 2 experienced observers	5 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Infants < 32 weeks of gestational age (< 31+6 weeks)

Exclusion Criteria:

Infants with ongoing analgesic treatment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

31 Weeks

Maximum Age

37 Weeks

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hakon Bergseng, PhD	St. Olavs Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St.Olavs University Hospital		Trondheim	Trøndelag	7006	Norway

Condition Browse Module

MeSH Terms

ID	Term
D047928	Premature Birth
D012164	Retinal Diseases
D010146	Pain

Ancestor Terms

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000082	Acetaminophen
D013395	Sucrose

Ancestor Terms

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

Browse Leaves

Not provided

Browse Branches

Not provided