NCT00218946

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

April 8, 2015

Status Verified

April 1, 2015

Enrollment Period

2.6 years

First QC Date

September 20, 2005

Last Update Submit

April 7, 2015

Conditions

Infant, Premature

Keywords

paininfant, prematureintubation, gastrointestinalNeonatal nursing

Outcome Measures

Primary Outcomes (1)

  • Pain measured on PIPP (Premature Infant Pain Profile) scale

    4 week to complete

Study Arms (6)

control

NO INTERVENTION

no fluid, no pacifier

water

EXPERIMENTAL

water, no pacifier

Other: sterile water

sucrose

EXPERIMENTAL

Sucrose, no pacifier

Drug: Sucrose

pacifier

EXPERIMENTAL

No fluid, pacifier

Device: Pacifier

water and pacifier

EXPERIMENTAL

water, pacifier

Device: Pacifier

sucrose and pacifier

EXPERIMENTAL

sucrose, pacifier

Drug: SucroseDevice: Pacifier

Interventions

SucroseDRUG

30 % sucrose

sucrosesucrose and pacifier
PacifierDEVICE
pacifiersucrose and pacifierwater and pacifier
sterile waterOTHER
water

Eligibility Criteria

Age3 Days - 8 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • weeks gestational weeks
  • not on mechanical ventilation

You may not qualify if:

  • high risk group regarding cerebral prognosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Olavs University Hospital

Trondheim, Trondheim, N-7006, Norway

Location

Related Publications (2)

  • 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.

    PMID: 8722730BACKGROUND

  • 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.

    PMID: 21536607RESULT

MeSH Terms

Conditions

Premature BirthPain

Interventions

SucrosePacifiers

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugarsInfant EquipmentEquipment and Supplies

Study Officials

  • Eirik Skogvoll, MD, PhD

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2005

First Posted

September 22, 2005

Study Start

January 1, 2005

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

April 8, 2015

Record last verified: 2015-04

Locations

NO(1)