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

Preterm Infant receiving Breast Milk or Glucose for Pain Relief Study (PIMiG Pain Study)

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000712202

Acronym

PIMiG Pain Study

Enrollment

Registered

2009-08-18

Start date

2009-08-07

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of the study is to compare the use of expressed breast milk and 25% glucose as analgesic strategies for pain relief in preterm neonates. The hypothesis is that breast milk is as effective as glucose.

Interventions

Orally administered expressed breast milk (volume: 2ml), prior to a single heel lance. Heel lance will be performed by using a mechanical device in which a stylet is placed in the spring-loaded cartridge. It takes less than 30 seconds to perform the puncture and blood collection.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

12 Hours to 72 Hours

Healthy volunteers

Yes

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

Outcome results