Nasogastric Tube in Premature Babies - Pain and Treatment

This study has been completed.
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00218946
First received: September 20, 2005
Last updated: April 7, 2015
Last verified: April 2015
  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
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Caregiver)
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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   up to 8 Weeks
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: September 20, 2005
Last Updated: April 7, 2015
Health Authority: Norway: Norwegian Social Science Data Services

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

ClinicalTrials.gov processed this record on June 30, 2015