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Two Methods of Analgesia for Chinese Term Infants Receiving Heel Lance

NCT01355640 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2012-01-31

No results posted yet for this study

Summary

1. The purpose of this study is to research and compare two sucking modes' effect(breast-feeding and non-nutritive sucking) and difference,hypothesis is that these two kinds of methods can decrease pain for Chinese term infants receiving heel stick.
2. A convenient sample of 90 neonates from a hospital in Beijing undergoing heel stick for Newborn Screening Program Blood Test were enrolled. They were randomized into three groups:

* breast-feeding group
* non-nutritive sucking group
* control group
3. The results showed that:

* Breast-feeding can reduce crying and grimace time, increase oxygen saturation.
* Non-nutritive sucking can delay grimace's starting time, increase oxygen saturation.

Conditions

  • Heel Pain Syndrome

Interventions

OTHER

breast-feeding

Mothers lay on the side of the bed comfortably with their infants in their arms after the infants' soiled diapers were changed. Mothers breast-fed their babies. The study was initiated when the infants were observed to have a large amount of areola in their mouth, with flanged lips and active jaw movements. Then two minutes after the breast-feeding, an experienced technician began to do heel lance, heel lance was given by the same experienced technician.Mothers breast-fed their babies two minutes before, during and eight minutes after the heel lance. Throughout the whole procedure, mothers were encouraged to continue breast-feeding when the babies stopped sucking and/or began to cry.

OTHER

non-nutritive sucking

Mothers lay on the side of the bed comfortably with their infants in their arms after the infants' soiled diapers were changed. Each mother in this group was given a vacuum pacifier( the brand is "Goodbaby") to console her baby. Heel lance was given by the same experienced technician. The study was initiated when the infants can suck the pacifier and hold it by himself without others' help. This generally requires half or one minute. Then two minutes after non-nutritive sucking, an experienced technician began to do heel lance. Babies sucked the pacifier two minutes before, during and eight minutes after heel lance. Throughout the whole procedure, mothers were encouraged to continue non-nutritive sucking when the babies stopped sucking and/or began to cry.

Sponsors & Collaborators

  • Peking Union Medical College

    lead OTHER

Principal Investigators

  • Jingli Chen, Master · Peking Union Medical College

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
72 Hours
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2008-11-30
Completion
2009-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01355640 on ClinicalTrials.gov