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| Name | Class |
|---|---|
| Stanford University | OTHER |
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The purpose of the study is to determine whether noninvasive electrical stimulation at acupuncture points (NESAP) and/or 24% sucrose is effective in reducing pain in infants during invasive procedures.
The investigators hypothesize that:
A collaborative prospective, double-blind, randomized trial will be performed at the University of Arkansas for Medical Sciences Hospital (Little Rock, AR), and Lucille Packard Children's Hospital (Palo Alto, CA). After obtaining IRB approval at both sites and parental consent, newborn infants less than 3 days of age who require heelsticks for clinical blood sampling will be randomized in a 2 × 2 factorial trial design to four groups: standard pain management with pacifier and water, Non-invasive Electrical Stimulation of Acupuncture Points (NESAP) with pacifier and water, 24% oral sucrose solution with pacifier, or NESAP plus oral sucrose solution and pacifier prior to their heelstick.
We will study the pain response to the heelstick routinely used to obtain blood for term neonatal infants by enrolling up to 192 infants, 96 from University of Arkansas for Medical Sciences and 96 from Lucille Packard Children's Hospital. This number will allow for screen failures and withdrawals. A minimum of 164 infants collectively from both sites is required to complete the study. Infants will be divided into 4 experimental groups:
Electrical stimulation will be applied at appropriate acupuncture points using a very low current for 10 minutes, routine for procedural pain. The response to pain will be assessed using a pain scale, heart rate, heart rate variability and oxygen saturation changes, duration of crying, and changes in salivary cortisol levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham NESAP with 24% oral sucrose | Experimental |
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| NESAP with oral water | Experimental |
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| NESAP with 24% oral sucrose | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NESAP | Device | Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at specific acupuncture points: ZuSanLi (ST36), SanYinJiao (SP6), Shen Mai (Bl60), and Shui Quan (KI3)46. StimCare electrodes with a gel base will be applied to the skin ; the skin will not be punctured by these procedures. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick. The display will be hidden from view to prevent the rater from being able to observe whether the unit is on. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes From Baseline Premature Infant Pain Profile (PIPP) Score to Average PIPP Score During Heel Stick and Squeeze. | The PIPP score includes assessment of contextual, physiological, and behavioral parameters and has been extensively validated for pain assessment in preterm and term infants. PIPP scores were given at baseline before initiation of the TENS unit,and every 30 seconds for the first two minutes of the heel stick and heel squeeze (4 times). The four PIPP scores given during heel stick and squeeze were averaged. Behavioral portion of PIPP score: facial expressions are videotaped and analyzed. Physiologic portion of PIPP score: Oxygen saturation levels and heart rates are recorded at baseline and then continuously throughout initiation of the TENS unit and the heel stick procedure. Contextual score - gestational age + sleep/wake state. Subscale scores are added for a total PIPP score. Total or composite PIPP scores are reported. Scores on the PIPP for full term infants range from 0-18, with 0 being no pain, 1-6 minimal pain, 7-12 moderate pain, 13-18 severe pain. | Baseline and first two minutes of heel stick an squeeze. PIPP scores are given every 30 seconds for the first two minutes of the heel stick and squeeze and then averaged.. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Salivary Cortisol After Heel Stick | Salivary cortisol was obtained prior to initiation of heelstick procedure, and at 5±0.5 minutes after procedure by gentle insertion in the mouth of a soft applicator (Salimetrics Infant Swab). The samples were stored at -20 degrees, and were analyzed at UAMS. | Baseline and 5±0.5 minutes after heel stick |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard W Hall, M.D. | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72223 | United States | ||
| Stanford University |
All infants enrolled in the study were assigned to groups.
Dates of recruitment: 4/10/2013 until 12/31/2014. Types of location: Postpartal/newborn units at University of Arkansas for Medical Sciences and Lucille Packard Childrens Hospital associated with Stanford University.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham NESAP With 24% Oral Sucrose |
|
| FG001 | NESAP With Oral Water | (a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on. (b) Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, four small electrodes will be placed in treatment groups on the baby's legs at specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick. Oral water:1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. |
| FG002 | NESAP With 24% Oral Sucrose | (a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, four small electrodes will be placed on the baby's legs at specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick. 24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier. |
| FG003 | Sham NESAP With Oral Water |
Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP). Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Newborns randomized to treatment groups during routine newborn screening
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| ID | Title | Description |
|---|---|---|
| BG000 | Sham NESAP With 24% Oral Sucrose |
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| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes From Baseline Premature Infant Pain Profile (PIPP) Score to Average PIPP Score During Heel Stick and Squeeze. | The PIPP score includes assessment of contextual, physiological, and behavioral parameters and has been extensively validated for pain assessment in preterm and term infants. PIPP scores were given at baseline before initiation of the TENS unit,and every 30 seconds for the first two minutes of the heel stick and heel squeeze (4 times). The four PIPP scores given during heel stick and squeeze were averaged. Behavioral portion of PIPP score: facial expressions are videotaped and analyzed. Physiologic portion of PIPP score: Oxygen saturation levels and heart rates are recorded at baseline and then continuously throughout initiation of the TENS unit and the heel stick procedure. Contextual score - gestational age + sleep/wake state. Subscale scores are added for a total PIPP score. Total or composite PIPP scores are reported. Scores on the PIPP for full term infants range from 0-18, with 0 being no pain, 1-6 minimal pain, 7-12 moderate pain, 13-18 severe pain. | Analysis of PIPP scores assigned during heelstick procedure in newborn infants | Posted | Mean | Standard Deviation | units on a scale (PIPP score) | Baseline and first two minutes of heel stick an squeeze. PIPP scores are given every 30 seconds for the first two minutes of the heel stick and squeeze and then averaged.. |
1 year, 8 months
No adverse events. Infants were monitored continuously throughout data collection period using heart monitor, oxygen saturation monitor, facial videotaping, neonatologist present at all times, pediatric physical therapist and nurse practitioner present at all times.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sham NESAP With 24% Oral Sucrose |
|
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We had difficulty collecting adequate saliva for salivary cortisol analysis. Many infants had insufficient saliva to run a reliable analysis, and numbers of infants with adequate saliva samples both before and after the heel stick were limited.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard W. Hall, professor of pediatrics, co-director of neonatal intensive care unit | University of Arkansas for Medical Sciences | 501-680-7894 | HallRichardw@uams.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013395 | Sucrose |
| D014867 | Water |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Sham NESAP with oral water | Placebo Comparator |
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| 24% oral Sucrose | Behavioral | One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier. |
|
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| Sham NESAP | Device | Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP). |
|
|
| Oral water | Behavioral | For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose. |
|
| Change in Heart Rate Variability During Heel Stick | Changes in Heart Rate Variability (HRV) were evaluated using the DL 900 monitor with 3-channel output with 5 leads. Premature infant leads from Braemar, Incorporated, were used with the DL 900 monitor. Leads were applied to the infant's chest before initiation of the TENS unit and the heel stick. The DL300 Holter Monitor will started recording HRV within 10 minutes of TENS unit initiation and the heel stick procedure and continued recording during the procedure and for 2 minutes afterwards. | Baseline, 20 minutes +/- 5 minutes |
| Duration of Crying After TENS Unit Was Initiated But Before Heel Stick. | (a) Any crying after initiation of TENS unit was noted. If the PIPP scores increased by 4 points from baseline, the TENS unit would have been turned off and the infant withdrawn from the study (safety outcome). | 10 minutes |
| Duration of Crying During Heel Stick | Any crying during the heel stick procedure was timed in seconds. | 5 minutes +/- 2 minutes |
| Stanford |
| California |
| 94305 |
| United States |
| BG001 | NESAP With Oral Water | (a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on. (b) Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, four small electrodes will be placed in treatment groups on the baby's legs. at specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick. Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. |
| BG002 | NESAP With 24% Oral Sucrose | (a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick. 24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier. |
| BG003 | Sham NESAP With Oral Water |
Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP). Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose. |
| BG004 | Total | Total of all reporting groups |
| days |
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| Gender | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Participants per treatment group | Number | participants |
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| Secondary | Change in Salivary Cortisol After Heel Stick | Salivary cortisol was obtained prior to initiation of heelstick procedure, and at 5±0.5 minutes after procedure by gentle insertion in the mouth of a soft applicator (Salimetrics Infant Swab). The samples were stored at -20 degrees, and were analyzed at UAMS. | Posted | Mean | Standard Deviation | ng/ml | Baseline and 5±0.5 minutes after heel stick |
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|
|
| Secondary | Change in Heart Rate Variability During Heel Stick | Changes in Heart Rate Variability (HRV) were evaluated using the DL 900 monitor with 3-channel output with 5 leads. Premature infant leads from Braemar, Incorporated, were used with the DL 900 monitor. Leads were applied to the infant's chest before initiation of the TENS unit and the heel stick. The DL300 Holter Monitor will started recording HRV within 10 minutes of TENS unit initiation and the heel stick procedure and continued recording during the procedure and for 2 minutes afterwards. | Newborn infants | Posted | Mean | Standard Deviation | LF/HF ratio | Baseline, 20 minutes +/- 5 minutes |
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| Secondary | Duration of Crying After TENS Unit Was Initiated But Before Heel Stick. | (a) Any crying after initiation of TENS unit was noted. If the PIPP scores increased by 4 points from baseline, the TENS unit would have been turned off and the infant withdrawn from the study (safety outcome). | Posted | Mean | Standard Deviation | seconds | 10 minutes |
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| Secondary | Duration of Crying During Heel Stick | Any crying during the heel stick procedure was timed in seconds. | Newborn infants during heel stick procedure, crying timed in seconds | Posted | Mean | Standard Deviation | seconds | 5 minutes +/- 2 minutes |
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| 0 |
| 37 |
| 0 |
| 37 |
| EG001 | NESAP With Oral Water | (a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on. (b) Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick. Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. | 0 | 37 | 0 | 37 |
| EG002 | NESAP With 24% Oral Sucrose | (a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick. 24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier. | 0 | 40 | 0 | 40 |
| EG003 | Sham NESAP With Oral Water |
Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP). Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose. | 0 | 39 | 0 | 39 |
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| D000073893 |
| Sugars |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |