Heel Pain Syndrome Clinical Trial
Official title:
A Randomized Controlled Trial of Breast-feeding and/or Non-nutritive Sucking as Analgesia for Chinese Term Infants Receiving Heel Lance
Verified date | January 2012 |
Source | Peking Union Medical College |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | May 2009 |
Est. primary completion date | November 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Infants were considered to be eligible if they have been three days old who need to receive heel lance for blood sampling test for phenylketonuria (PKU), hyperbilirubinemia, thyroid hypofunction. - Parents of infants who met the research criteria were invited to participate in the study. Exclusion Criteria: - Infants were excluded if they had a concurrent illness. - Preterm babies, and babies who have received any operation after birth. - Infant' mother who had a fever or some illness was excluded. - Infants for whom an informed parental consent could not be obtained were also excluded. - During the heel lance, the infants who need to receive two heel lances were also excluded. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | changes in heart rate value and oxygen saturation value,time length of grimacing and crying | 1 minute before heel lance and 8 minutes after heel lance, the duration of facial grimacing and crying, heart rate and oxygen saturation values at every 15 seconds.Time length of heart rate, oxygen saturation returned to baseline values | No |
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