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OpenTrials
Completed

NCT Number: NCT00218946

Nasogastric Tube in Premature Babies - Pain and Treatment

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

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Key information

Conditions

Infant, Premature Female Urogenital Diseases and Pregnancy Complications Neurologic Manifestations Obstetric Labor Complications Obstetric Labor, Premature Pain Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Signs and Symptoms Urogenital Diseases

Age range

3 day–8 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

St. Olavs University Hospital

Trondheim, N-7006, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • high risk group regarding cerebral prognosis

Treatment and study plan

Sucrose

Drug

30 % sucrose

Pacifier

Device

Sterile Water

Other

Primary outcomes

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

    Time frame: 4 week to complete

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • St. Olavs Hospital

Registry information

Official study title

Nasogastric Tube in Premature Babies - Pain and Treatment. A Randomised, Partly Blinded, Placebo-controlled Factorial Clinical Trial of Sucrose and Pacifier

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Sep 22, 2005
Registry last updated
Apr 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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