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CompletedNCT00218946Updated Apr 8, 2015

Nasogastric Tube in Premature Babies - Pain and Treatment

A Phase 2 interventional study of Sucrose and Pacifier in Infant, Premature, sponsored by Norwegian University of Science and Technology. Completed at 1 site in Norway. Open to participants aged 3 Days to 8 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-08.

Sponsored by Norwegian University of Science and Technology · Phase 2 and Interventional

Phase
Phase 2
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
3 Days to 8 Weeks
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Infant, Premature

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Keywords

  • pain
  • infant, premature
  • intubation, gastrointestinal
  • Neonatal nursing
03

In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's enrollment of 24 is below the median of 84 across 1,689 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Norwegian University of Science and Technology is the lead sponsor of 487 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Days to 8 Weeks
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • high risk group regarding cerebral prognosis
05

Study design

Phase
Phase 2
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Care provider)
Enrollment
24 participants (actual)

Study arms

  • No intervention
    control

    no fluid, no pacifier

  • Experimental
    water

    water, no pacifier

    Other: sterile water

  • Experimental
    sucrose

    Sucrose, no pacifier

    Drug: Sucrose

  • Experimental
    pacifier

    No fluid, pacifier

    Device: Pacifier

  • Experimental
    water and pacifier

    water, pacifier

    Device: Pacifier

  • Experimental
    sucrose and pacifier

    sucrose, pacifier

    Drug: Sucrose · Device: Pacifier

Interventions

  • DrugSucrose

    30 % sucrose

  • DevicePacifier
  • Othersterile water
06

What researchers measure

Primary outcomes

  1. Pain measured on PIPP (Premature Infant Pain Profile) scale

    Time frame: 4 week to complete

07

Study locations

1 site
  • St. Olavs University Hospital
    Trondheim, N-7006, Norway
08

References and documents

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. doi: 10.1097/00002508-199603000-00004. PubMed 8722730 ↗
  • Kristoffersen L, Skogvoll E, Hafstrom 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. PubMed 21536607 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00218946
Lead sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
Responsible party
Sponsor
First posted
Sep 22, 2005
Start date
Jan 2005
Primary completion
Aug 2007
Completion
Aug 2007
Last update
Apr 8, 2015

Study contacts

Eirik Skogvoll, MD, PhD
study director · Norwegian University of Science and Technology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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