Trial Outcomes & Findings for Effects of Acupuncture in the Treatment of Infant Colic (NCT NCT00907621)
NCT ID: NCT00907621
Last Updated: 2015-03-17
Results Overview
Crying time per 24 hour period at baseline and post treatment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
90 participants
Primary outcome timeframe
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.
Results posted on
2015-03-17
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
45
|
|
Overall Study
COMPLETED
|
38
|
41
|
|
Overall Study
NOT COMPLETED
|
7
|
4
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
3
|
|
Overall Study
intercurrent febrile illness
|
1
|
1
|
Baseline Characteristics
Effects of Acupuncture in the Treatment of Infant Colic
Baseline characteristics by cohort
| Measure |
Acupuncture
n=44 Participants
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.
|
Control
n=40 Participants
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.
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6 weeks
n=5 Participants
|
6 weeks
n=7 Participants
|
6 weeks
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
baseline crying time in minutes
|
220 crying time in minutes
n=5 Participants
|
212 crying time in minutes
n=7 Participants
|
216 crying time in minutes
n=5 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Acupuncture
n=38 Participants
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.
|
Control
n=41 Participants
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.
|
|---|---|---|
|
Change in Crying Time Per 24 Hour Period.
Day 5- 3 intervention day
|
129 minutes crying time pr 24 hour
Interval 97.0 to 162.0
|
167 minutes crying time pr 24 hour
Interval 123.0 to 211.0
|
|
Change in Crying Time Per 24 Hour Period.
Day 1 and 2-baseline
|
220 minutes crying time pr 24 hour
Interval 195.0 to 245.0
|
212 minutes crying time pr 24 hour
Interval 183.0 to 241.0
|
|
Change in Crying Time Per 24 Hour Period.
Day 3- 1 intervention day
|
230 minutes crying time pr 24 hour
Interval 180.0 to 281.0
|
186 minutes crying time pr 24 hour
Interval 142.0 to 230.0
|
|
Change in Crying Time Per 24 Hour Period.
Day 4- 2 intervention day
|
180 minutes crying time pr 24 hour
Interval 128.0 to 232.0
|
185 minutes crying time pr 24 hour
Interval 131.0 to 239.0
|
|
Change in Crying Time Per 24 Hour Period.
Day 6- 1 day after intervention
|
120 minutes crying time pr 24 hour
Interval 94.0 to 145.0
|
142 minutes crying time pr 24 hour
Interval 106.0 to 179.0
|
|
Change in Crying Time Per 24 Hour Period.
Day12- 1 week after intervention
|
121 minutes crying time pr 24 hour
Interval 79.0 to 164.0
|
120 minutes crying time pr 24 hour
Interval 91.0 to 149.0
|
|
Change in Crying Time Per 24 Hour Period.
Day 33- 4 weeks after intervention
|
89 minutes crying time pr 24 hour
Interval 55.0 to 123.0
|
97 minutes crying time pr 24 hour
Interval 67.0 to 126.0
|
SECONDARY outcome
Timeframe: 5 days, 1 , and 4 weeks after the first treatmentPopulation: 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.
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.
Outcome measures
| Measure |
Acupuncture
n=38 Participants
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.
|
Control
n=37 Participants
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.
|
|---|---|---|
|
Parents Evaluation of Benefit to the Child.
Improvement day 5
|
2.87 units on a scale
Standard Deviation 0.844
|
2.78 units on a scale
Standard Deviation 0.917
|
|
Parents Evaluation of Benefit to the Child.
Improvement day 12
|
3.62 units on a scale
Standard Deviation 0.861
|
3.27 units on a scale
Standard Deviation 0.902
|
|
Parents Evaluation of Benefit to the Child.
Improvement day 33
|
4.03 units on a scale
Standard Deviation 0.885
|
3.51 units on a scale
Standard Deviation 1.146
|
Adverse Events
Acupuncture
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Acupuncture
n=45 participants at risk
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.
|
Control
n=45 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Hickup
|
2.2%
1/45 • Number of events 1
|
0.00%
0/45
|
|
Gastrointestinal disorders
Increased regurgitation
|
2.2%
1/45 • Number of events 1
|
0.00%
0/45
|
|
General disorders
Small Hematoma
|
0.00%
0/45
|
2.2%
1/45 • Number of events 1
|
|
General disorders
Crying
|
0.00%
0/45
|
2.2%
1/45 • Number of events 1
|
|
General disorders
Restlessness
|
0.00%
0/45
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Excessive stools
|
0.00%
0/45
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Frequent defecation
|
0.00%
0/45
|
2.2%
1/45 • Number of events 1
|
|
General disorders
Light sedation
|
0.00%
0/45
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/45
|
2.2%
1/45 • Number of events 1
|
|
General disorders
Unease
|
0.00%
0/45
|
2.2%
1/45 • Number of events 1
|
Additional Information
Dr. Holgeir Skjeie
Department of General practice, University of Oslo
Phone: +4722850550
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place