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Nasogastric Tube in Premature Babies - Pain and Treatment

This study has been completed.
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology Identifier:
First received: September 20, 2005
Last updated: April 7, 2015
Last verified: April 2015
Does sucrose or pacifier influence pain in premature babies when a nasogastric tube is inserted?

Condition Intervention Phase
Infant, Premature
Drug: Sucrose
Device: Pacifier
Other: sterile water
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Care Provider)
Official Title: Nasogastric Tube in Premature Babies - Pain and Treatment. A Randomised, Partly Blinded, Placebo-controlled Factorial Clinical Trial of Sucrose and Pacifier

Resource links provided by NLM:

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Pain measured on PIPP (Premature Infant Pain Profile) scale [ Time Frame: 4 week to complete ]

Enrollment: 24
Study Start Date: January 2005
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control
no fluid, no pacifier
Experimental: water
water, no pacifier
Other: sterile water
Experimental: sucrose
Sucrose, no pacifier
Drug: Sucrose
30 % sucrose
Experimental: pacifier
No fluid, pacifier
Device: Pacifier
Experimental: water and pacifier
water, pacifier
Device: Pacifier
Experimental: sucrose and pacifier
sucrose, pacifier
Drug: Sucrose
30 % sucrose
Device: Pacifier

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.

Ages Eligible for Study:   up to 8 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 28 - 32 weeks gestational weeks
  • not on mechanical ventilation

Exclusion Criteria:

  • high risk group regarding cerebral prognosis
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Please refer to this study by its identifier: NCT00218946

St. Olavs University Hospital
Trondheim, Norway, N-7006
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Study Director: Eirik Skogvoll, MD, PhD Norwegian University of Science and Technology
  More Information

Responsible Party: Norwegian University of Science and Technology Identifier: NCT00218946     History of Changes
Other Study ID Numbers: NISE-2005-1
Study First Received: September 20, 2005
Last Updated: April 7, 2015

Keywords provided by Norwegian University of Science and Technology:
infant, premature
intubation, gastrointestinal
Neonatal nursing

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications processed this record on May 25, 2017