An interventional study of Milk bottle administration and Water bottle administration in Clubfoot, sponsored by Shriners Hospitals for Children. Completed. Open to participants aged 1 Day to 6 Months. Per ClinicalTrials.gov, last updated 2017-12-15.
Sponsored by Shriners Hospitals for Children · Not applicable, Interventional, and Supportive care
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While it has been shown that sucrose or milk ingestion decreases pain responses in heel sticks, no study up to this point has determined the best intervention for decreasing the pain response during casting for clubfoot deformity.
The goal of this study is to investigate the effect of three different non-pharmacologic interventions (sucrose, milk, water) on pain response during clubfoot casting.
This study will allow us to discern the best non-pharmacologic intervention for pain control during clubfoot casting and to provide a more pleasant, comfortable experience for patients and families.
Clubfoot deformity in newborns is common, occurring in 1-2/1000 births. Treatment of this deformity has shifted from surgical to non-surgical management. The non-surgical management includes utilizing the Ponseti technique of manipulation and casting, followed by Achilles tenotomy and brace application. The newborn undergoes, on average, 4-6 casts before the foot deformity is corrected. During this manipulation and casting, the infants can become fussy and irritable. This irritability is likely due to discomfort felt from the manipulative process and subsequent casting.
Studies that have focused on decreasing the pain response to heel sticks for laboratory testing in the neonatal intensive care units used sucrose or milk ingestion and swaddling in newborns to decrease pain responses. Both sucrose and milk have been shown to decrease the pain response as measured by the Premature Infant Pain Profile (PIPP) or the Bernese Pain Scale for Neonates. In addition, other pain scales have been used in newborn babies including the CRIES, CHIPPS, NIPS, and COMFORT scales to evaluate the effectiveness of pain relieving interventions. These scales were used alongside objective physiologic measurements such as heart rate, heart rate variability (HRV), respiratory rate, and oxygen saturation.
While it has been shown that sucrose or milk ingestion decreases pain responses in heel sticks, no study up to this point has determined the best intervention for decreasing the pain response during casting for clubfoot deformity. The goal of this study is to investigate the effect of three different non-pharmacologic interventions (sucrose, milk, water) on pain response during clubfoot casting, allowing us to discern the best non-pharmacologic intervention for pain control during clubfoot casting and to provide a more pleasant, comfortable experience for patients and families. A secondary objective is to investigate whether or not family environment or the level of anxiety felt by the parents impacts the pain felt by the infant during the casting process.
69 studies on the registry are indexed under Clubfoot; 15 are open to participants now.
This study's enrollment of 33 is below the median of 38 across 40 interventional studies indexed under Clubfoot.
Browse Clubfoot studies →Shriners Hospitals for Children is the lead sponsor of 56 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Milk bottle administration
Other: Milk bottle administration · Other: Water bottle administration · Other: Sucrose bottle administration
Water bottle administration
Other: Milk bottle administration · Other: Water bottle administration · Other: Sucrose bottle administration
Sucrose bottle administration
Other: Milk bottle administration · Other: Water bottle administration · Other: Sucrose bottle administration
Patients are given a bottle of milk during the casting process.
Patients are given a bottle of water during the casting process.
Patients are given a bottle of sucrose during the casting process.
NIPS (Neonatal Infant Pain Scale)
Each cast visit will be videotaped before, during, and after casting, and later reviewed for subjective evaluation of pain using NIPS (Neonatal Infant Pain Scale). The NIPS examines six behavioral groupings that contribute to a pain score ranging from 0 to 7: facial expression (relaxed muscles or grimace), cry (no cry, whimper, or vigorous cry), breathing patterns (relaxed, change in breathing), arms (relaxed/restrained, flexed/extended), legs (relaxed/restrained, flexed/extended), state of arousal (sleeping/awake, fussy). Scoring will take place by a trained study personnel blinded to the contents of the bottle. Scoring for all measures will be recorded at minute intervals. A pre casting score from the average of the first 3 minute scores prior to casting; a during casting score from the average of the scores at 1 minute intervals during casting; and a post casting score from the average of the 3 minute scores post casting. Scores are categorized as 0 no pain, to \>4 severe pain.
Time frame: Scoring will be recorded at minute intervals starting at 2 minutes prior to casting and ending at 3 minutes post casting.
Heart Rate
Heart rate will be recorded at minute intervals. A pre casting measure from the average of the first 3 minute measures prior to casting; a during casting measure from the average of the measures at 1 minute intervals during casting; and a post casting measure from the average of the 3 minute measures post casting.
Time frame: Heart rate will be recorded at minute intervals starting at 2 minutes prior to casting and ending at 3 minutes post casting.
Oxygen Saturation
Oxygen saturation will be recorded at minute intervals. A pre casting measure from the average of the first 3 minute measures prior to casting; a during casting measure from the average of the measures at 1 minute intervals during casting; and a post casting measure from the average of the 3 minute measures post casting.
Time frame: Oxygen saturation will be recorded at minute intervals starting at 2 minutes prior to casting and ending at 3 minutes post casting
53 participants were assessed for eligability. 33 patient participants and their guardians were enrolled in the study from 3/13/13 to 9/17/14 at their initial clinical visit. A total of 131 casts were performed.
| Milestone | All Participants |
|---|---|
| Started | 33 |
| Sequence 1 (s,s,m,m,w,w) | 2 |
| Sequence 2 (w,s,s,m,m,w) | 2 |
| Sequence 3 (w,w,s,s,m,m) | 2 |
| Sequence 4 (m,w,w,s,s,m) | 2 |
| Sequence 5 (m,m,w,w,s,s) | 2 |
| Sequence 6 (s,m,m,w,w,s) | 2 |
| Sequence 7 (s,s,w,w,m,m) | 2 |
| Sequence 8 (m,s,s,w,w,m) | 2 |
| Sequence 9 (m,m,s,s,w,w) | 2 |
| Sequence 10 (w,m,m,s,s,w) | 2 |
| Sequence 11 (w,w,m,m,s,s) | 2 |
| Sequence 12 (s,w,w,m,m,s) | 2 |
| Sequence 13 (s,m,w,m,s,w) | 2 |
| Sequence 14 (w,s,m,w,m,s) | 2 |
| Sequence 15 (s,w,s,m,w,m) | 2 |
| Sequence 16 (m,s,w,s,m,w) | 1 |
| Sequence 17 (w,m,s,w,s,m) | 1 |
| Sequence 18 (m,w,m,s,w,s) | 1 |
| Completed | 33 |
| Not completed | 0 |
Each cast visit will be videotaped before, during, and after casting, and later reviewed for subjective evaluation of pain using NIPS (Neonatal Infant Pain Scale). The NIPS examines six behavioral groupings that contribute to a pain score ranging from 0 to 7: facial expression (relaxed muscles or grimace), cry (no cry, whimper, or vigorous cry), breathing patterns (relaxed, change in breathing), arms (relaxed/restrained, flexed/extended), legs (relaxed/restrained, flexed/extended), state of arousal (sleeping/awake, fussy). Scoring will take place by a trained study personnel blinded to the contents of the bottle. Scoring for all measures will be recorded at minute intervals. A pre casting score from the average of the first 3 minute scores prior to casting; a during casting score from the average of the scores at 1 minute intervals during casting; and a post casting score from the average of the 3 minute scores post casting. Scores are categorized as 0 no pain, to \>4 severe pain.
| units on a scale | Milk | Water | Sucrose |
|---|---|---|---|
| NIPS pre casting | 2.28 ± 2.38 | 1.63 ± 2.12 | 1.84 ± 2.18 |
| NIPS casting | 0.91 ± 1.26 | 2.22 ± 2.01 | 0.63 ± 1.27 |
| NIPS post casting | 2.11 ± 2.37 | 1.49 ± 2.29 | 0.69 ± 1.53 |
Heart rate will be recorded at minute intervals. A pre casting measure from the average of the first 3 minute measures prior to casting; a during casting measure from the average of the measures at 1 minute intervals during casting; and a post casting measure from the average of the 3 minute measures post casting.
| bpm | Milk | Water | Sucrose |
|---|---|---|---|
| pre casting | 152.72 ± 20.45 | 145.69 ± 17.12 | 155.9 ± 15.71 |
| casting | 152.54 ± 12.87 | 152.59 ± 9.03 | 154.33 ± 24.55 |
| post casting | 147.2 ± 12.05 | 143.89 ± 13.06 | 149.78 ± 12.99 |
Oxygen saturation will be recorded at minute intervals. A pre casting measure from the average of the first 3 minute measures prior to casting; a during casting measure from the average of the measures at 1 minute intervals during casting; and a post casting measure from the average of the 3 minute measures post casting.
| percentage of SpO2 | Milk | Water | Sucrose |
|---|---|---|---|
| pre casting | 98 ± 1.57 | 97.52 ± 2.26 | 98.33 ± 1.63 |
| casting | 97.38 ± 1.26 | 97.56 ± 3.23 | 94.32 ± 12.43 |
| post casting | 98.07 ± 2.07 | 97.85 ± 2.34 | 98.18 ± 1.62 |
Collected over up to four weeks after study participation. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sucrose | — | 0/29 (0%) | 1/29 (3.4%) |
| Milk or Formula | — | 0/26 (0%) | 0/26 (0%) |
| Water | — | 0/26 (0%) | 0/26 (0%) |
| Event | Sucrose | Milk or Formula | Water |
|---|---|---|---|
| Gastrointestinal disorderGastrointestinal disorders | 1/29 | 0/26 | 0/26 |
Analysis included 43 casts receiving sucrose, 37 casts receiving milk or formula, and 42 casts receiving water
| Age, Customized(participants) | All Participants |
|---|---|
| <=18 years | 33 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(days) | All Participants |
|---|---|
| Mean | 17.9 ± 20.5 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 9 |
| Male | 24 |
| Region of Enrollment(participants) | All Participants |
|---|---|
| United States | 33 |
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
The record gives a start of Jan 2013, a primary completion of Oct 2014 and a completion of Oct 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Dec 2017, 3 years 2 months after primary completion.
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This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Shriners Hospitals for Children