Two Methods of Analgesia for Chinese Term Infants Receiving Heel Lance (NCT01355640) | Clinical Trial Compass
CompletedNot Applicable
Two Methods of Analgesia for Chinese Term Infants Receiving Heel Lance
90 participantsStarted 2008-04
Plain-language 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.
Who can participate
Age range
72 Hours
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
changes in heart rate value and oxygen saturation value,time length of grimacing and crying
Timeframe: 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