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Nasogastric Tube in Premature Babies - Pain and Treatment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00218946
First Posted: September 22, 2005
Last Update Posted: April 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
  Purpose
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 (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.
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

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

Exclusion Criteria:

  • high risk group regarding cerebral prognosis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00218946


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

Publications:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00218946     History of Changes
Other Study ID Numbers: NISE-2005-1
First Submitted: September 20, 2005
First Posted: September 22, 2005
Last Update Posted: April 8, 2015
Last Verified: April 2015

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

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications