Nasogastric Tube in Premature Babies - Pain and Treatment

• Sponsor: Norwegian University of Science and Technology (Other)
• Overall Status: Completed
• CT.gov ID: NCT00218946
• Collaborator: St. Olavs Hospital (Other)
• Enrollment: 24
• Location: 1
• Arms: 6
• Duration (Months): 30.9
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Infant, Premature	Drug: Sucrose; Device: Pacifier; Other: sterile water	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• 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
• Study Start Date: Jan 1, 2005
• Actual Primary Completion Date: Aug 1, 2007
• Actual Study Completion Date: Aug 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Pain measured on PIPP (Premature Infant Pain Profile) scale [4 week to complete]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Days to 8 Weeks
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Norwegian University of Science and Technology
• ClinicalTrials.gov Identifier: NCT00218946
• Other Study ID Numbers: NISE-2005-1
• First Posted: Sep 22, 2005
• Last Update Posted: Apr 8, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by Norwegian University of Science and Technology: pain; infant, premature; intubation, gastrointestinal; Neonatal nursing
• Additional relevant MeSH terms: Premature Birth

Study Results

No Results Posted as of Apr 8, 2015