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NCT00218946 Clinical Trial

Nasogastric Tube in Premature Babies - Pain and Treatment

Infant, Premature Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00218946
Other study ID # NISE-2005-1
Secondary ID
Status Completed
Phase Phase 2
First received September 20, 2005
Last updated April 7, 2015
Start date January 2005
Est. completion date August 2007

Study information
Verified date April 2015
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority Norway: Norwegian Social Science Data Services
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date August 2007
Est. primary completion date August 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 8 Weeks
Eligibility Inclusion Criteria:

- 28 - 32 weeks gestational weeks

- not on mechanical ventilation

Exclusion Criteria:

- high risk group regarding cerebral prognosis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Caregiver)

Related Conditions & MeSH terms

Intervention

Drug:
• Sucrose
30 % sucrose
Device:
• Pacifier

Other:
• sterile water

Locations
Country Name City State
Norway St. Olavs University Hospital Trondheim

Sponsors (2)
Lead Sponsor Collaborator
Norwegian University of Science and Technology St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Kristoffersen L, Skogvoll E, Hafström M. Pain reduction on insertion of a feeding tube in preterm infants: a randomized controlled trial. Pediatrics. 2011 Jun;127(6):e1449-54. doi: 10.1542/peds.2010-3438. Epub 2011 May 2. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Pain measured on PIPP (Premature Infant Pain Profile) scale 4 week to complete No
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