Heel Pain SyndromeNCT01355640
Two Methods of Analgesia for Chinese Term Infants Receiving Heel Lance
A study testing breast-feeding and non-nutritive sucking in people with Heel Pain Syndrome, run by Peking Union Medical College.
Trial 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. Read more about this study
- Who is it for?
- Ages 72 hours and olderHealthy volunteers can take part
- Conditions the study is for
- Heel Pain Syndrome
- What is being tested?
- breast-feeding and non-nutritive sucking
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to May 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 72 hours and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: A Randomized Controlled Trial of Breast-feeding and/or Non-nutritive Sucking as Analgesia for Chinese Term Infants Receiving Heel Lance
- 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.
- 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
- 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.
Read the detailed description
Untreated pain will also cause long term impact on newborns,Some scientists in foreign countries have done some research on rats, they found that if rats were exposed to pain for a long time, its nociception neural circuit's development will be harmed, and the pain threshold will be lowered. For newborns, untreated pain will cause hypalgesia when they are in puberty and hyperalgesia after adulthood. The experience of pain in infancy also affects the babies' later life after they grow up, it may cause emotional problems, minimal brain dysfunction, social intercourse defect and so on. So it is very important to find out useful interventions to decrease pain in newborns, considering the long term impact and side effect of medicine, it is seldom to use medical interventions to decrease pain. Non-pharmacological interventions become quite important. In foreign countries, there have been kinds of useful non-pharmacological interventions such as kangaroo care, breast-feeding, sucrose and non-nutritive sucking. While in China, there are massage, positioning, sucrose, music and kangaroo care that proved to be effective to decrease pain in newborns. The investigators find few reports about breastfeeding or non-nutritive sucking's effect of decreasing pain in term newborns. For breast-feeding, it includes the nursing mother who has consoling impact, hugging, attention transferring, taste, the breast milk contains tryptophane, which is the precursor of N-acetyl-5-O-T that can raise up the density of β-endorphin, β-endorphin has analgesic effect. For non-nutritive sucking, it also contains attention transferring. It is said that non-nutritive sucking can raise up the pain threshold through stimulating the oral tactile recipient, or promote the releasing of 5-HT that modulates pain. Non-nutritive sucking can also lower the sensitivity of peripheral nerves.
- Conditions
- Heel Pain Syndrome
- Being tested
- breast-feeding, non-nutritive sucking
- Keywords
- heel lance, pain, newborn
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breast-feedingOther
Also called non-pharmacological intervention
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.
non-nutritive suckingOther
Also called non-pharmacological intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| breast-feeding group | Experimental | Mothers console their babies by breast-feeding during heel lance. Receives: Other: breast-feeding |
| non-nutritive sucking | Experimental | Every mother was given a vacuum pacifier( the brand is "Goodbaby") to console her baby during heel lance. Receives: Other: non-nutritive sucking |
| control group | No intervention | A research nurse also explained the study to the control group parents. Standard clinic procedure for infant injection was also implemented. Mothers in control group also lay on the side of the bed comfortably with their infants in their arms after the infants' soiled diapers were changed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in heart rate value and oxygen saturation value,time length of grimacing and crying
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2011 (estimated)
- Study startApr 2008
- Primary completionNov 2008
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heel Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pingni, Huazhong University of Science and Technology
- Investigators
- Jingli Chen, Master, Study director, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01355640
- Sponsor's protocol ID
- S2006471
- Status last verified
- Jan 2012
- First submitted
- 16 May 2011
- Last updated
- 31 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Breast-feeding and/or Non-nutritive Sucking as Analgesia for Chinese Term Infants Receiving Heel Lance
- ClinicalTrials.gov ID
- NCT01355640
- Acronym / sponsor ID
- S2006471
- Conditions
- Heel Pain Syndrome
- Keywords
- heel lance, pain, newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Peking Union Medical CollegeUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 18 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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
- 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.
Detailed description
Untreated pain will also cause long term impact on newborns,Some scientists in foreign countries have done some research on rats, they found that if rats were exposed to pain for a long time, its nociception neural circuit's development will be harmed, and the pain threshold will be lowered. For newborns, untreated pain will cause hypalgesia when they are in puberty and hyperalgesia after adulthood. The experience of pain in infancy also affects the babies' later life after they grow up, it may cause emotional problems, minimal brain dysfunction, social intercourse defect and so on. So it is very important to find out useful interventions to decrease pain in newborns, considering the long term impact and side effect of medicine, it is seldom to use medical interventions to decrease pain. Non-pharmacological interventions become quite important. In foreign countries, there have been kinds of useful non-pharmacological interventions such as kangaroo care, breast-feeding, sucrose and non-nutritive sucking. While in China, there are massage, positioning, sucrose, music and kangaroo care that proved to be effective to decrease pain in newborns. The investigators find few reports about breastfeeding or non-nutritive sucking's effect of decreasing pain in term newborns. For breast-feeding, it includes the nursing mother who has consoling impact, hugging, attention transferring, taste, the breast milk contains tryptophane, which is the precursor of N-acetyl-5-O-T that can raise up the density of β-endorphin, β-endorphin has analgesic effect. For non-nutritive sucking, it also contains attention transferring. It is said that non-nutritive sucking can raise up the pain threshold through stimulating the oral tactile recipient, or promote the releasing of 5-HT that modulates pain. Non-nutritive sucking can also lower the sensitivity of peripheral nerves.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| breast-feeding group | Experimental | Other: breast-feedingMothers console their babies by breast-feeding during heel lance. |
| non-nutritive sucking | Experimental | Other: non-nutritive suckingEvery mother was given a vacuum pacifier( the brand is "Goodbaby") to console her baby during heel lance. |
| control group | No intervention | –A research nurse also explained the study to the control group parents. Standard clinic procedure for infant injection was also implemented. Mothers in control group also lay on the side of the bed comfortably with their infants in their arms after the infants' soiled diapers were changed. |
Who may qualify
- Ages
- 72 hours and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| breast-feedingAlso: non-pharmacological interventionMothers 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 | breast-feeding group |
| non-nutritive suckingAlso: non-pharmacological interventionMothers 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. | Other | non-nutritive sucking |
Primary outcome
changes in heart rate value and oxygen saturation value,time length of grimacing and crying
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jingli Chen, Master study director
Peking Union Medical College
Questions about this trial
What is this clinical trial studying?
A study testing breast-feeding and non-nutritive sucking in people with Heel Pain Syndrome, run by Peking Union Medical College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in heart rate value and oxygen saturation value,time length of grimacing and crying (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2012.