Infant Colic
Conditions
Keywords
Infant Colic, Acupuncture, General Practice
Brief summary
Standardized acupuncture treatment for infant colic is a common treatment in general practice for doctors educated in medical acupuncture. The investigators plan to study whether the perceived opinion on positive results can be verified in a multi-center clinical trial. The investigators aim to measure the effect of standardized acupuncture treatment, three repeated sessions, on infant colic in a randomized singe blinded prospective multi-center study, starting September 2009. The study will be done in thirteen locations in Norway by specialists in General Practice trained in acupuncture. The investigators intend to include a total of 130 patients, 65 in the intervention group and 65 in the control group.
Interventions
PROCEDUREAcupuncture with Seirin 020x15 mm sterile acupuncture needle
Bilateral insertion of a Seirin 020x15mm sterile acupuncture needle to a depth of 12mm for 30 seconds during 3 consecutive working days at the WHO designated acupuncture point St36.
Sponsors
University of Oslo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
3 Weeks to 3 Months
Healthy volunteers
Yes
Inclusion criteria
* Infants under 3 months of age with birth weight over 2500 g and/or over 36th week of gestation. * Further fulfilling Wessel et al criteria for infant colic: Paroxystic uncontrollable crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying per day for more than 3 days a week for more than 3 weeks.
Exclusion criteria
* Infants over 3 months of age with birth weight under 2500 g and/or under 36th week of gestation. * Not fulfilling Wessel et al criteria for infant colic: Paroxystic uncontrollable crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying pr.day for more than 3 days a week for more than 3 weeks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Crying Time Per 24 Hour Period. | 6 time points measured: First, second and third intervention day, one day after last intervention, one week after last intervention and one month after last intervention. All time points measured in 24 hours. | Crying time per 24 hour period at baseline and post treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parents Evaluation of Benefit to the Child. | 5 days, 1 , and 4 weeks after the first treatment | Parents subjective assessment of the childs condition, on a 5 point scale, with 1 being worse and 5 being completely well. The numbers are the actual evaluations on the time specified. |
Countries
Norway
Participant flow
Recruitment details
The inclusion period was from September 2009 to December 2012.13 GP offices participated. The participating doctors were all GP specialists with a minimum of 300 hours of acupuncture education and fi ve years of practising acupuncture. The patients fulfi lled Wessel ' s criteria and were born at full term.
Pre-assignment details
113 pasients were recruited. 23 were excluded beacuse of spontanous improving of symptoms, transportation problems, change of mind regarding participation.90 patients were randomized. 79 crying diaries and 84 interviews were analysed.
Participants by arm
| Arm | Count |
|---|---|
| Acupuncture Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:
Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.
Acupuncture with Seirin 020x15 mm sterile acupuncture needle : Bilateral insertion of a Seirin 020x15mm sterile acupuncture needle to a depth of 12mm for 30 seconds during 3 consecutive working days at the WHO designated acupuncture point St36.
The baseline characteristics of age and gender are based on the 84 collected interviews, while the crying time baseline units are based on the 79 collected crying time diaries. This is why numbers differ from the Participant Flow module. Only 79 participants were analyzed for crying time. | 44 |
| Control Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:
Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.
The Control group will have no intervention.
The baseline characteristics of age and gender are based on the 84 collected interviews, while the crying time baseline units are based on the 79 collected crying time diaries. This is why numbers differ from the Participant Flow module. Only 79 participants were analyzed for crying time. | 40 |
| Total | 84 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | intercurrent febrile illness | 1 | 1 |
| Overall Study | Lost to Follow-up | 6 | 3 |
Baseline characteristics
| Characteristic | Acupuncture | Control | Total |
|---|---|---|---|
| Age, Continuous | 6 weeks | 6 weeks | 6 weeks |
| baseline crying time in minutes | 220 crying time in minutes | 212 crying time in minutes | 216 crying time in minutes |
| Sex: Female, Male Female | 22 Participants | 20 Participants | 42 Participants |
| Sex: Female, Male Male | 22 Participants | 20 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 45 | 8 / 45 |
| serious Total, serious adverse events | 0 / 45 | 0 / 45 |
Outcome results
Primary
Change in Crying Time Per 24 Hour Period.
Crying time per 24 hour period at baseline and post treatment
Time frame: 6 time points measured: First, second and third intervention day, one day after last intervention, one week after last intervention and one month after last intervention. All time points measured in 24 hours.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Acupuncture | Change in Crying Time Per 24 Hour Period. | Day 4- 2 intervention day | 180 minutes crying time pr 24 hour |
| Acupuncture | Change in Crying Time Per 24 Hour Period. | Day 6- 1 day after intervention | 120 minutes crying time pr 24 hour |
| Acupuncture | Change in Crying Time Per 24 Hour Period. | Day 3- 1 intervention day | 230 minutes crying time pr 24 hour |
| Acupuncture | Change in Crying Time Per 24 Hour Period. | Day12- 1 week after intervention | 121 minutes crying time pr 24 hour |
| Acupuncture | Change in Crying Time Per 24 Hour Period. | Day 5- 3 intervention day | 129 minutes crying time pr 24 hour |
| Acupuncture | Change in Crying Time Per 24 Hour Period. | Day 33- 4 weeks after intervention | 89 minutes crying time pr 24 hour |
| Acupuncture | Change in Crying Time Per 24 Hour Period. | Day 1 and 2-baseline | 220 minutes crying time pr 24 hour |
| Control | Change in Crying Time Per 24 Hour Period. | Day 33- 4 weeks after intervention | 97 minutes crying time pr 24 hour |
| Control | Change in Crying Time Per 24 Hour Period. | Day 1 and 2-baseline | 212 minutes crying time pr 24 hour |
| Control | Change in Crying Time Per 24 Hour Period. | Day 3- 1 intervention day | 186 minutes crying time pr 24 hour |
| Control | Change in Crying Time Per 24 Hour Period. | Day 4- 2 intervention day | 185 minutes crying time pr 24 hour |
| Control | Change in Crying Time Per 24 Hour Period. | Day 5- 3 intervention day | 167 minutes crying time pr 24 hour |
| Control | Change in Crying Time Per 24 Hour Period. | Day 6- 1 day after intervention | 142 minutes crying time pr 24 hour |
| Control | Change in Crying Time Per 24 Hour Period. | Day12- 1 week after intervention | 120 minutes crying time pr 24 hour |
Secondary
Parents Evaluation of Benefit to the Child.
Parents subjective assessment of the childs condition, on a 5 point scale, with 1 being worse and 5 being completely well. The numbers are the actual evaluations on the time specified.
Time frame: 5 days, 1 , and 4 weeks after the first treatment
Population: The differences in numbers on parents evaluation of the childs condition (37 and 38) is due to one location assistant not reporting back on these results. Thus the number of interviews, 84, and secondary outcome data is not consistent with the numbers in the flow diagram.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acupuncture | Parents Evaluation of Benefit to the Child. | Improvement day 5 | 2.87 units on a scale | Standard Deviation 0.844 |
| Acupuncture | Parents Evaluation of Benefit to the Child. | Improvement day 12 | 3.62 units on a scale | Standard Deviation 0.861 |
| Acupuncture | Parents Evaluation of Benefit to the Child. | Improvement day 33 | 4.03 units on a scale | Standard Deviation 0.885 |
| Control | Parents Evaluation of Benefit to the Child. | Improvement day 5 | 2.78 units on a scale | Standard Deviation 0.917 |
| Control | Parents Evaluation of Benefit to the Child. | Improvement day 12 | 3.27 units on a scale | Standard Deviation 0.902 |
| Control | Parents Evaluation of Benefit to the Child. | Improvement day 33 | 3.51 units on a scale | Standard Deviation 1.146 |