Preterm Infant receiving Breast Milk or Glucose for Pain Relief Study (PIMiG Pain Study): a randomised controlled trial.

Not Applicable

Completed

• Conditions: Pain in neonates related to heel lancing; Alternative and Complementary Medicine - Other alternative and complementary medicine

• Registration Number: ACTRN12609000712202
• Lead Sponsor: The State of Sao Paulo Research Foundation (FAPESP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-08-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

Near term neonates

Exclusion Criteria

Oral fasting, alteration of swallow or gag reflexes, assisted ventilation, born to mothers who have human immunodeficiency virus (HIV) and/or C hepatitis, born to mothers users of illicit drugs, proven or suspected intracranial hemorrhage grade II or more, neonates who underwent surgery, use of analgesic or sedatives for less than 24 hours before the procedure, proven or suspected necrotizing enterocolitis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Premature Infant Pain Profile scores[30 seconds after the painful procedure]

Secondary Outcome Measures

Name	Time	Method
Heart rate (measured by an electrocardiogram (ECG) monitor)[Baseline (15 seconds before the procedure)<br>After the painful procedure (each 30 seconds after the procedure, during 3 minutes)]