Nasogastric Tube in Premature Babies - Pain and Treatment - Tabular View

Tracking Information

First Received Date ^ICMJE

September 20, 2005

Last Updated Date

February 2, 2009

Start Date ^ICMJE

January 2005

Primary Completion Date

August 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pain measured on PIPP (Premature Infant Pain Profile) scale [ Time Frame: 4 week to complete ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Pain measured on PIPP (Premature Infant Pain Profile) scale

Change History

Complete list of historical versions of study NCT00218946 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

non

Descriptive Information

Brief Title ^ICMJE

Nasogastric Tube in Premature Babies - Pain and Treatment

Official Title ^ICMJE

Nasogastric Tube in Premature Babies - Pain and Treatment. A Randomised, Partly Blinded, Placebo-Controlled Factorial Clinical Trial of Sucrose and Pacifier

Brief Summary

Does sucrose or pacifier influence pain in premature babies when a nasogastric tube is inserted?

Detailed Description

A total of 24 premature babies are randomised to receive either placebo (sterile water), 30 % sucrose, or pacifier in a complete factorial, cross-over design. Pain is rated on the PIPP scale by observers blinded to the procedure other than use of pacifier.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other, Randomized, Single Blind (Caregiver), Placebo Control, Factorial Assignment, Efficacy Study

Condition ^ICMJE

Infant, Premature

Intervention ^ICMJE

Drug: Sucrose
Device: Pacifier

Study Arms / Comparison Groups

No Intervention: no fluid, no pacifier
Experimental: water, no pacifier
Experimental: Sucrose, no pacifier
Experimental: No fluid, pacifier
Experimental: water, pacifier
Experimental: sucrose, pacifier

Publications *

Stevens B, Johnston C, Petryshen P, Taddio A. Premature Infant Pain Profile: development and initial validation. Clin J Pain. 1996 Mar;12(1):13-22.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2007

Primary Completion Date

August 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

28 - 32 weeks gestational weeks
not on mechanical ventilation

Exclusion Criteria:

high risk group regarding cerebral prognosis

Gender

Both

Ages

up to 8 Weeks

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Norway

Administrative Information

NCT ID ^ICMJE

NCT00218946

Responsible Party

Eirik Skogvoll, MD PhD, Norwegian University of Science and Technology

Study ID Numbers ^ICMJE

NISE-2005-1

Study Sponsor ^ICMJE

Norwegian University of Science and Technology

Collaborators ^ICMJE

St. Olavs Hospital

Investigators ^ICMJE

Study Director:

Eirik Skogvoll, MD, PhD

Norwegian University of Science and Technology

Information Provided By

Norwegian University of Science and Technology

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP